Law On Medical Devices

Original Language Title: Loi en matière de dispositifs médicaux

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Read the untranslated law here: http://www.ejustice.just.fgov.be/cgi/article_body.pl?numac=2013024422&caller=list&article_lang=F&row_id=1000&numero=1048&pub_date=2013-12-20&dt=LOI&language=fr&fr=f&choix1=ET&choix2=ET&fromtab=+moftxt&trier=publication&sql=dt+=+'LOI'&tri=pd+AS+RANK+

Posted the: 2013-12-20 Numac: 2013024422 PUBLIC SERVICE FEDERAL public health, food chain safety and environment 15 December 2013. -Law on medical devices PHILIPPE, King of the Belgians, to all, present and future, hi.
The Chambers have adopted and we endorse the following: title 1.-available introductory Article 1.
This Act regulates a matter referred to in article 78 of the Constitution.
TITLE 2. -Amending provisions Chapter 1. -Amendments to the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994 Section 1st. -Auxiliary paramedical s. (2. in article 2, m), the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994, amended by the law of 24 December 1999 and 22 August 2002, the words "i.e. persons" who provide implants and invasive medical devices are inserted between the words "implants providers", and the words "dismissed".
Section 2. -S. Healthcare Insurance Committee 3. at article 22 of the Act, as amended by the law of December 27, 2012, the following changes are made: 1 ° in the 4 ° bis, the words "referred to in article 27, paragraph 3, and article 29bis, 3 °" are replaced by "referred to in article 27, paragraph 3, article 29bis, 3 °, and article 29ter, paragraph 4 , 3.,".
2 ° a 4 ° ter is inserted worded as follows: "4 ° ter. is pronounced in accordance with article 35septies/3, § 3, on the adjustments to the lists of implants and invasive medical devices; ";
3 ° article is supplemented by the 19th, as follows: "(19° conclut les conventions avec les établissements hospitaliers visés à l'article 2, n), in regards to the implants and invasive medical devices intended for limited clinical applications such as defined under section 35septies/2, § 2, 4 °.".
Section 3. -College of doctors-directors art. 4. article 23 of the Act, as amended by the law of 20 December 1995, April 29, 1996, February 22, 1998, January 25, 1999, December 24, 1999, August 22, 2002, July 13, 2006, 27 December 2006, 18 March 2009, December 10, 2009, 23 December 2009 and 27 December 2012 and by the royal decree of 25 April 1997, is complemented by a § 7 as follows: "§ § 7 7" The College of doctors-Directors has for mission to decide on the granting of health benefits referred to in article 34, paragraph 1, 4 ° bis, when this decision is one of the conditions for reimbursement referred to in article 35septies/1, § 2, paragraph 2, 3 °, and to establish, where appropriate, the amount. "."
Section 4. -Special fund of solidarity article (5. in article 25quater, paragraph 2 f), of the same Act, inserted by the law of 27 April 2005, the words "or the Committee referred to in article 29ter" are inserted between the word "competent" and the words "received".
S. 6. in article 25quinquies, § 4, of the Act, inserted by the law of 27 April 2005 and amended by the Act of 27 December 2005, the words "referred to in article 35 § 4, 2 ° and 3 ° and article 35bis of the annex to the royal decree of 14 September 1984 establishing the nomenclature of health insurance compulsory health care and compensation benefits" are replaced by the words "determined in accordance with article 35septies/1 , § 2, paragraph 2, 5 °, with regard to the benefits referred to in article 34, paragraph 1, 4 ° bis. "."
Section 5. -Conseils techniques art. 7. in article 27, paragraph 1, of the Act, as amended by the law of 10 August 2001 and 27 December 2005, the words "and a technical Council of implants" are repealed.
Section 6. -Reimbursement of implants and invasive medical devices Arts commission 8. at article 29ter of the Act, restored by the law of 13 December 2006 and amended by the Act of 27 December 2006, the following changes are made: 1 ° in the text of paragraph 2, second sentence, the word "invasieve" is inserted between the word "en" and the words "medische hulpmiddelen";
2 ° in paragraph 4, 1., the words "in article 35septies" shall be replaced by the words "in articles 35septies/2 and 35septies/3";
3 ° paragraph 4, is supplemented by the 3. 5. worded as follows: "3 to formulate the Committee proposals for interpretative rules insurance;
4. to request medical advice and doctors-Directors College provide advice as part of an application of the compulsory insurance for benefits referred to in article 34, paragraph 1, 4 ° bis, before them;
5. to formulate a notice with respect to the provision of article 34, paragraph 1, 4 ° bis, at the request of the boards referred to in article 27. "."
Section 7. -Benefits of health arts
9. the article 34, paragraph 1, 4 ° bis, of the same Act, inserted by the law of December 13, 2006, the following changes are made: 1 ° in the a), the words "(à l'exception de ceux visés sous 1°, e) including osteo-integrated implants used in dentistry" are replaced by the words "(à l'exception de ceux visés sous 1°, e), including osteo-integrated implants used in dentistry and implants and invasive medical devices used in the mouth" or on the face which minimum intraoral or extraoral part is visible";
2 ° b) is supplemented by the words "(, à l'exception de ceux visés àle a)".
Section 8. -Notification s.
10 A article 35septies, § 1, of the same Act inserted by the law of 13 December 2006 and amended by the Act of 27 December 2006, the following changes are made: 1 ° in the paragraph 1, the words "§ 1" are repealed;
2 ° in the paragraph 1, the word "firm" is replaced by the word "business";
3 ° in paragraph 3, the words "The firm" shall be replaced by the words "Company";
4 ° paragraph 8 is replaced by the following: "the costs of implants and invasive medical devices for long-term non-notified, use which, on the basis of this article, are not exempt from the obligation of notification, cannot be worn in charge of beneficiaries." These costs do not account for an intervention of compulsory insurance, except for devices that come into consideration for the special solidarity fund intervention. "."
Section 9. -Reimbursement of implants and invasive medical devices article 11. in the same Act, it is inserted an article 35septies/1 as follows: "article 35septies/1. § 1.
The list of implants and refundable invasive medical devices referred to in article 34, paragraph 1, 4 ° bis, consists of a list of benefits with their repayment terms, hereinafter referred to as "list", only to those benefits is associated with or a list of names of implants and invasive medical devices, called hereinafter "list of names".
The King fixed the lists referred to in paragraph 1, no later than six months after the entry into force of this section.
A list of names can be associated with benefits answering one or more of the following conditions: 1 ° the implant or invasive medical device is an active implantable medical device within the meaning of Directive 90/385 / EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices or device at high risk within the meaning of Directive 93/42 / EEC of 14 June 1993 concerning devices medical;
2 ° of the additional guarantees are provided regarding the quality of the implant or invasive medical device;
3 ° additional guarantees are provided for appropriate pricing of the implant or invasive medical device.
§ 2. The list referred to the § 1, paragraph 1, contains terms and conditions determined by the King.
These repayment terms are designed according to the benefits: 1 ° the basis of reimbursement;
2 ° reimbursement category and sub-category of reimbursement;
3 ° the conditions for reimbursement.
(4) the method of reimbursement, lump or no lump;
5 ° the safety margin, expressed in the form of a percentage of the basis for reimbursement;
6 ° the price ceiling.
Implants and invasive medical devices sales VAT included price exceeding the ceiling price referred to in paragraph 2, 6 °, or the basis of reimbursement referred to in paragraph 2, 1 °, increased by the margin of security referred to in paragraph 2, 5 °, where it applies, cannot be taken into account for an intervention of compulsory insurance.
In the case of lump-sum intervention of compulsory insurance, no-cost device can be worn in the beneficiary's account.
§
3. The list referred to the § 1 reproduces the personal intervention referred to in article 37, § 2, paragraph 1.
§ 4. The nominative list referred to the § 1, shall provide the information determined by the King for the individual designation of implants and invasive medical devices and the identification of the company.
This list contains useful information aimed at ensuring the transparency of pricing, including supplement payable by the beneficiary in respect of margin of safety. "."
S. 12. in the Act, it is inserted a section 35septies/2 as follows: "article 35septies/2. § 1. The list, such as defined in article 35septies/1, § 1, paragraph 1, can be adapted by the Minister on a proposal from the commission referred to in article 29ter: 1 ° at the request of the undertaking which makes the implant or invasive medical device on the Belgian market, hereinafter referred to as "the applicant";
2 ° at the request of the Minister;
3 ° at the request of the commission referred to in article 29ter.
§ 2. Adaptations of the list may include:

1 ° in the recording of a performance;
2 ° in the modification of a benefit or its terms of repayment;
3 ° in the removal of a benefit;
4 ° in the temporary registration of a benefit under a limited clinical application as defined by the King.
§ 3. The decision on the request for the adaptation of the list is taken by the Minister after evaluation of one or more of the following criteria by the commission referred to in article 29ter: 1 ° the therapeutic value of the implant or invasive medical device, expressed in one of the two following classes:-class 1: implants or invasive medical devices having a therapeutic value or economic-health demonstrated compared to existing therapeutic alternatives;
-class 2: implant or invasive medical devices have no therapeutic value or economic-health demonstrated compared to existing therapeutic alternatives;
2 ° the price of implant or invasive medical device and the reimbursement basis proposed in the application of adaptation;
3 ° the interest of the implant or invasive medical device in medical practice based on the therapeutic and social needs existing;
4 ° the budgetary impact for insurance compulsory health care;
5 ° the ratio between the cost for insurance compulsory health care and therapeutic value.
§ 4. The King may define the criteria referred to in § 3 in more detail, how the class an implant or invasive medical device is attached and define in more detail the criteria referred to in § 3, 2 ° to 5 °, which are at least evaluated depending on the class of the implant or the invasive medical device that has been mentioned by the applicant. The King may subdivide the classes into sub-classes and determine what are the criteria referred to in § 3, 2 ° to 5 °, which are at least evaluated.
§ 5. In the case of a request for the adaptation of the list, introduced by an applicant, on implants and invasive medical devices for long-term use, the commission referred to in article 29ter formulates a final reasoned proposal. The maximum period in which the final reasoned proposal of the commission referred to in article 29ter is formulated is 180 days and begins on the day following the day when demand for adaptation has been declared admissible.
The King sets the manner in which the above time limit of 180 days may be suspended.
Within 45 days of taking courses the next day of the day of receipt of the request for the adaptation, the secretariat of the Committee referred to in article 29ter decides on the admissibility of the application.
If the information provided in support of the request for the adaptation are insufficient, the secretariat immediately puts the applicant aware of detailed additional information that are still required. A new deadline of 45 days commences on the day following the day where the missing information is received by the secretariat of the Committee referred to in article 29ter.
The King determines the conditions and modalities under which the applicant is informed of the reasoned decision about the admissibility of the request for the adaptation.
The King sets the terms of the advertising provided by health care Service adaptation applications declared admissible.
The secretariat of the Committee referred to in article 29ter communicates to the applicant the date of admissibility of the request for the adaptation.
If there are insufficient elements accompanying the application of adaptation after assessment to be able to make a reasoned proposal, the time limit of 180 days is suspended and the commission referred to in article 29ter informed without delay to the applicant what additional elements are still required.
Within a period of 60 days after the receipt of the reasoned final proposal of the commission referred to in article 29ter or information that no final reasoned proposals could be formulated, the Minister takes a reasoned decision on the reasoned final proposal of the commission referred to in article 29ter after agreement of the Minister who has the Budget in charge, or absence of definitive reasoned proposals of the commission referred to in article 29ter, about the request for the adaptation of the list.
The absence of reaction of the Minister who has the Budget in charge within 30 days of the agreement request, consent is assumed to be tacit.
The King fixed by Decree deliberated in the Council of Ministers the conditions and the manner in which the Minister may waive the final reasoned proposal of the commission referred to in article 29ter within the period of 60 days referred to in paragraph 9.
Absence of a decision of the Minister within that period, the decision is supposed to be in accordance with the final reasoned proposal of the commission referred to in article 29ter.
Absence of final reasoned proposals of the commission referred to article 29ter within 180 days and if the Minister has not also taken of decision within this period, the proposal for the adaptation of the most recent list of the applicant is deemed to be accepted, except in the case referred to in § 7, paragraph 2.
§ 6. The King determines the procedure for adapting the list applications submitted by an applicant, other than those referred to in § 5.
The King also determines the procedure for adapting the list claims that may be made at any time by the Minister or the commission referred to article 29ter.
The Minister decides requests for adaptation of the list referred to in paragraph 1 on the basis of a reasoned final proposal made by the commission under article 29ter.
After the agreement of the Minister who has the Budget in its attributions, the Minister takes a reasoned decision about the final reasoned proposal for the adaptation of the list made by the commission under article 29ter.
The King determines by Decree deliberated in the Council of Ministers the conditions and the manner in which the Minister may waive the final reasoned proposal of the commission referred to in article 29ter.

§ 7. The King determines the procedure according to which the commission referred to in article 29ter, may, during the procedures mentioned in the §§ 5 and 6, make a proposal for a temporary repayment in a clinical application limited where it considers that the implant or invasive medical device requires a period of assessment.
Absence of reasoned final proposal for a temporary repayment in a clinical application limited to the commission referred to article 29ter and if the Minister has not also taken decision, the request for the adaptation of the list is closed by the secretariat of the Committee referred to in article 29ter.
However, with regard to the procedure with delay, absence of definitive reasoned proposals for temporary repayment in a clinical application limited to the commission and before the decision of the Minister, the applicant can communicate to the Minister its desire to conclude a contract with the Institute, which provides rules for compensation for compulsory insurance health care and benefits even the elements about which still reigns of insecurity and for which the applicant must conduct an evaluation at the time fixed in the contract.
The King fixed by Decree deliberated in the Council of Ministers the conditions and rules under which such a contract may be concluded between the applicant and the Institute.
The King determines the procedure with regard to the period of assessment referred to in paragraph 1.

§ 8. The King may determine in more detail the procedures referred to in §§ 5 to 7, including as regards the composition and content of requests for adaptation and counter-proposals made by the applicant, as well as the computation and the suspension of time limits and the conditions to which the applicant is deemed to have abandoned its request for the adaptation.
§ 9. The King may extend to other invasive medical devices the procedure and the time limits referred to in § 5.
§ 10. The decision of the Minister with respect to requests for adaptation of the list submitted by an applicant is limited in its scope to the contents of this request for the adaptation, except if the decision does not affect the existing rights of the other undertakings concerned. "."
S. 13. in the same Act inserted an article 35septies/3 as follows: "article 35septies/3. § 1. A list of names, as referred to in article 35septies/1, § 1, can be adapted by the Insurance Committee on a proposal from the commission referred to in article 29ter: 1 ° at the request of the undertaking which makes the implant or invasive medical device on the Belgian market, hereinafter referred to as the applicant;
2 ° at the request of the Minister;
3 ° at the request of the commission referred to in article 29ter.
§ 2. Adaptations of a nominative list may consist of: 1 ° the recordation of an individual implant or individual invasive medical device under its terms of repayment, previously defined on the list with existing delivery;
2 ° with the deletion of a single implant or individual invasive medical device;
3 ° in the modification of one or more of the facts determined by the King.
§ 3. The decision on the request for the adaptation of a nominative list is taken by the Committee of insurance within the time limits and in accordance with the procedure determined by the King.
§ 4. The decision of the Insurance Committee on the adaptation of a nominative list at the request of an applicant is limited in its scope to the contents of the request for the adaptation. "."
S.

14. in the same Act inserted an article 35septies/4 as follows: "article 35septies/4.
The King may, for decisions of the Minister or the Insurance Committee it determines, the procedure for publication of these decisions using the Internet at the address http://inami.fgov.be, as well as the modalities according to which the Institute health care Service follows the technical adjustments of the list or a list of names. "."
S. 15. in the Act, it is inserted a section 35septies/5 as follows: "article 35septies/5. § 1. The Minister's decision on a request for the adaptation of the list comes into force on the date determined by the Ministerial Decree of confirmation of this decision.
By way of derogation from paragraph 1, if the decision is positive of the Minister for the inclusion of a provision on the list, as referred to in article 35septies/2, §§ 5 to 7, or if the Minister is assumed to have confirmed a reasoned final proposal for the inclusion of a provision on the list of the Committee referred to in article 29ter, the decision of the Minister enter into force the first day of the month following that in which the decision was published via the network internet à l'adresse http://inami.fgov.be
Par dérogation à
l'alinéa 1er, entre également en vigueur le premier jour du mois qui suit celui au cours
duquel elle est publiée au moyen du réseau internet à l'adresse http://inami.fgov.be, la proposition
la plus récente du demandeur qui est réputée acceptée conformément à l'article 35septies/2, §
5, alinéa 13, à la condition qu'elle se rapporte à l'inscription d'une prestation sur la liste.

§ 2. The decision of the Committee of insurance on a request for the adaptation of a nominative list enter into force the first day of the month following that in which the decision was published through the Internet at the address http://inami.fgov.be § 3. Publication of decisions by means of the internet network referred to the § 1, paragraph 2, and at § 2 takes place at the latest within 30 days of the adoption of these decisions. "."
S. 16. in the same Act, it is inserted an article 35septies/6 worded as follows: "Article 35septies/6. The Minister may annually make full and without taking into account rules of procedure referred to in this Act the republication of the list and the lists, without making any changes in terms of content.
The Minister fits right the lists as a result of the changes made in relation to the margin of licensing referred to in article 44, § 1, paragraph 3.
The King may determine the cases in which the Institute health care Service can propose adaptations of the list to the Minister or the lists to the Committee of insurance without intervention by the commission under article 29ter when technical corrections of errors. "."
Section 10. -Intervention personal art. 17A article 37 of the Act, as amended by the Act of March 19, 2013, the following changes are made: 1 ° in § 2, paragraph 3, the words "as well as the list and lists of implants and invasive medical devices refundable" are inserted between the word "refundable" and the words "in relation to the amount of the personal intervention";
2 ° in the § 14(b), article 3 is repealed.
S.
18. in article 37sexies, paragraph 5, inserted by the Act of 27 December 2005 and amended by the law of July 24, 2008, the words "put supplement payable by the beneficiary as a margin of safety, as defined in article 35 § 4, and article 35bis, § 4, of the nomenclature of health benefits ' are replaced by the words"the supplement to be borne by the recipient as a margin of safety , as referred to in article 35septies/1, § 2, paragraph 2, 5 °, and § 4, paragraph 2 "."
Section 11. -Commission of agreements art. 19 A section 44, § 1, of the Act, as amended by the law of 20 December 1995, February 22, 1998 and December 19, 2008, the following changes are made: 1 ° in the paragraph 1, the words "providers of prostheses, devices and implants" are replaced by the words "providers of prostheses and appliances";
2 ° the § is supplemented by a paragraph worded as follows: "with regard to the benefits referred to in article 34, paragraph 1, 4 ° bis, the Commission of agreements between implants providers and insurers is competent to set the margin for the issue. The issue margin covers the information by the hospital pharmacist to the establishments referred to in article 2, n), and the potential will on the reimbursement of implants and invasive medical devices. The margin of issue covers also purchasing, stock management, infertility and the issuance of these implants and invasive medical devices as well as, in accordance with the legal requirements, dispensing and monitoring the way these implants and invasive medical devices. "."
Section 12. -Section Xvia s. 20. in title III, chapter V, of the same Act, section Xvia is inserted: "Section Xvia - of the obligations of business for admission to the reimbursement of implants and invasive medical devices referred to in article 34, paragraph 1, 4 ° bis".
S. 21. in section Xvia, inserted by article 20, it is inserted an article 75A, as follows: "article 75. § 1. Until the entry into force of the decision of redeemability of implants and invasive medical devices for which a request for the adaptation of the list or a list of names was introduced, all the changes that relate or may relate to the devices concerned and to the operation of the undertaking and which are useful for the treatment of the request shall be immediately reported by the company to the attention of the secretariat of the Committee referred to in article 29ter.
§ 2. Under the insurance mandatory health care and subject to other legal provisions, from the entry into force of the decision on the redeemability of implants and invasive medical devices, the company respects the following obligations, which are included in the application forms the model established by the King: 1 ° ensuring the continuity of the placing on the market of the implant or invasive medical device;
2 ° without prejudice to the obligation referred to in § 3, immediately inform the secretariat of the commission referred to in article 29ter of its own withdrawal from the Belgian market or the withdrawal of the Belgian market of the implant or invasive medical device;
3 ° communicating the number of implants or refundable invasive medical devices that have been distributed on the Belgian market the previous year;
4 ° communicate immediately to the secretariat of the commission referred to in article 29ter modification of one of the elements of the request for the adaptation;
5 ° immediately communicate the information it requested in case of request for the adaptation of the list or a list of names introduced at the initiative of the Minister or the commission under article 29ter;
6 ° communicate immediately any malfunction or undesirable side effect of the implant or invasive medical device to the secretariat of the commission referred to in article 29ter;
7 ° take the necessary measures following the existing warranty conditions to cover adequately the suffered health damage resulting directly from malfunction or a unwanted side effect of the implant or invasive medical device.
The King determines the date limit to be satisfied the obligation of communication referred to in paragraph 1, 3 °. It can determine to what invasive medical devices or implants may be waived the obligation referred to in paragraph 1, 3 °.
§ 3. When a company that puts an implant or invasive medical device on the Belgian market wishes to permanently withdraw the redeemability of this implant and this invasive medical device and continues to put on the Belgian market the implant or invasive medical device, it introduces for that purpose a request for deletion of the list or the list of names of implants and invasive medical devices refundable referred to in article 35septies/1 , § 1.
For reasons related to public health or welfare, the Minister may reject the application for discontinuance.
King lays down the arrangements for the removal of implants and invasive medical devices and the date of entry into force of this deletion.
§ 4. In the context of the procedures referred to in articles 35septies/1 35septies/6, the company shall immediately communicate to the secretariat of the Committee referred to in article 29ter all useful data that him are required for decision making by the Minister or the Insurance Committee.
§ 5. To ensure compliance with the obligations laid down by this article and without prejudice to the provisions it has adopted, the King determines, at the end of the period of two years provided for the assessment of the reimbursement system, procedures and compliance with the procedures, conditions and procedures under which the failings of business obligations, evidenced by the secretariat of the Committee referred to in article 29ter may give rise , after prior warning, to a penalty.
These conditions and procedures are particularly determined depending on the severity of the observed failure of recurrences and consequences of the sanction for the insured. "."
Section 13. -Provisions repealing art.

22. article 54 of the law of 13 December 2006 laying down various provisions health is repealed, except that it inserts article 35septies, § 1, of the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994.
Articles 56 and 57 of the Act of 13 December 2006 are hereby repealed.
Section 14. -Entry into force and transitional provisions art. 23. This chapter enter into force July 1, 2015.
The King may set a date of entry into force earlier than referred to in paragraph 1.
The King determines the transitional provisions applicable to applications submitted before the date of entry into force.
CHAPTER 2. -Hospitals and other care arts. 24A article 102 of the coordinated Act of July 10, 2008, on hospitals and other institutions of care, the following changes are made: 1 ° 4 ° is replaced by the following: "(4° les frais liés àles implants visés à l'article 34, alinéa 1er, 4° bis, a) of the law on compulsory insurance health care and benefits" (, co-ordinated on 14 July 1994, with the exception: a) submitted implants to the obligation of notification, pursuant to article 35septies of the Act, and is not subject to notification;
(b) implants provided by the King of the obligation of notification in accordance with article 35septies, paragraph 5, of the Act and are not the object of an intervention of compulsory insurance in accordance with the repayment terms established;
(c) tissue, stick adhesive and Haemostatic products when these are not intervention of compulsory insurance in accordance with the terms of repayment laid down;
(d) implants that can not enter into consideration for effective intervention of compulsory insurance in accordance with article 35 f/1, § 2, paragraph 3, of the Act;
(e) implants that were the subject of a negative decision by the Minister following a negative assessment of the commission referred to in article 29ter of the Act, carried out in accordance with article 35septies/2, § 3, of the Act or of a negative decision by the Insurance Committee following a negative of the abovementioned commission assessment, in accordance with article 35septies/3 , § 3 of the same Act. ";
2 ° in 5 °, the words "under the conditions" are replaced by the words "in accordance with the terms and conditions".
S. 25. article 24 comes into force July 1, 2015.
The King may set a date of entry into force earlier than referred to in paragraph 1.
S. 26. by way of derogation from article 60 of the law of 13 December 2006 laying down various provisions on health, section 59, 2 ° of the Act comes into force July 1, 2015.
The King may set a date of entry into force earlier than referred to in paragraph 1.
CHAPTER 3. -Amendments to the law of 25 March 1964 on medicines article 27. article 9, § 4, of the law of 25 March 1964 on medicines, inserted by the law of April 27, 2005, is supplemented by three paragraphs, worded as follows: "the purpose of protection of public health, the King may extend the prohibition of advertising laid down in paragraph 1 to any other implantable medical devices medical devices." To this end, the King establishes a commission to provide advice to the Minister or his delegate about the risk an medical device poses to public health.
The King sets the composition and modalities of operation of the commission.
By way of derogation from paragraph 5, the King can load an existing body with a notice skill, which has the necessary experience in medical devices, the issuance of notice referred to in paragraph 1."
S. 28. in article 14, § 3, of the Act, replaced by the Act of 22 December 2003, a paragraph worded as follows is inserted between paragraphs 3 and 4: "the original record is sent to the officer designated in accordance with article 17, § 1 of this Act."
S. 29. in the same Act, it is inserted an article 16A as follows: "article 16bis. § 1. By derogation from article 16, without prejudice to the comminees by the penal Code penalties: 1 ° is punished by imprisonment from eight days to one month and a fine of 100 EUR to 1000 EUR or one of those penalties only, that contravenes the taken orders in pursuance of article 1bis of the Act;
2 ° 1 ° Notwithstanding, is punished by imprisonment of one month to one year and a fine of 200 EUR 15.000 EUR or one of those penalties only, that which: has) violates Title 3, Chapter 3, of the Act of... in medical devices or taken orders in pursuance of this chapter;
(b) in any capacity whatsoever, puts into service, distributes, acquires or uses in any way whatsoever a medical device under conditions which he knows or should know that they are in contradiction with the specific distribution legal rules established for the medical device;
c) distributes, acquires or uses in any capacity whatsoever, a medical device which he knows or should know that it does not meet the provisions laid down by or pursuant to title 3, Chapter 3, of the Act of... in medical devices, or taken orders in pursuance of this chapter.
§ 2. By way of derogation to the § 1, is punished by imprisonment of one to three years and a fine of 1,000 EUR 100,000 EUR or one of those penalties only, that which: 1 ° unduly affix a conformity marking for medical devices on an instrument, apparatus, equipment, material or other article to facilitate its market introduction commissioning, its traffic and its use in any capacity whatsoever.
2 ° matter, puts on the market, offers for service, allows to circulate or uses in any capacity whatsoever an instrument, apparatus, equipment, material or other article on which a mark of conformity medical devices is unduly affixed within the meaning of the 1st while he knows or should know the undueness of this marking;
3 ° imports, puts on the market, puts into service, allows to circulate or uses in any capacity whatsoever an instrument, apparatus, equipment, material or any other article without conformity marking for medical devices that he knows or should know that such marking is mandatory;
4 ° is the manufacturer or the authorised representative of a manufacturer and does not available or does not provide the FAMHP declarations of conformity to the technical documentation of medical devices need, puts on the market or puts into service;
5 ° contravenes article 9, § 4; this Act or orders for the implementation of this Act
§ 3. Is also punished by imprisonment of one to three years and a fine of 1,000 EUR 100,000 EUR or one of these sentence only, the fact: 1 ° for the manufacturer, importer or distributor of a device, to have had knowledge of an incident or a risk of incident involving a medical device resulting or likely to result in death or serious state of health of a patient deterioration a user or a third party, and to refrain to notify without delay to the FAMHP.
2 ° for the health care professional, to have had personal knowledge, in the exercise of its functions, of an incident or a risk of incident of a similar nature, and to refrain to notify without delay the FAMHP.
The FAMHP lays down the detailed rules for the way in which the notifications referred to in paragraph 1 are carried out, and publishes on its web site. The FAMHP may make compulsory the use of a form."
S.
30. in article 16, § 3, 1 °, of the Act, as last amended by the Act of June 20, 2013, the words "article 9" are replaced by the words "article 9, §§ 1 to 3", art. 31. at section 17 of the Act, as amended by the Act of 27 December 2006, the following changes are made: 1 ° the § 1 is replaced by the following: "§ 1." Infringement under Title 3, Chapter 3, of the Act of... medical devices or orders made pursuant to this chapter, the official licensee of the doctoral degree, license or master in law, designated for this purpose by the Deputy of the FAMHP, transmits a copy of the minutes of finding of infringement, for information, to the Prosecutor of the King.
The designated officer on the basis of paragraph 1 may propose to the offender a transaction whose payment off public action in accordance with paragraph 6.
The transaction referred to in paragraph (2) is sent to the author of the offence within three months of the date of the report. A copy of this proposal shall be forwarded for information to the Prosecutor of the King.
In the event of payment for the transaction, the official designated on the basis of paragraph 1 of the present paragraph shall notify immediately the Prosecutor of the King, by registered post. A copy of this notification is addressed to the author of the offence, by registered post.
In the event of non-payment of the transaction, the minutes passed to King's attorney.
If no transaction proposal is made by the designated officer on the basis of paragraph 1, the latter transmits the minutes to the Prosecutor of the King within a period of three months from the date of the minutes.
The payment for the transaction off public action, unless the Prosecutor shall notify the author of the offence, within one month from the notification of the payment referred to in paragraph 4, that it intends to exercise this action. The notification takes place via registered post.

If public action is introduced after payment for the transaction and leads to the conviction of the person concerned, the amount of the transaction is then charged on the costs of justice due to the State and the pronounced fine. Any excess is rendered. In the case of acquittal, the amount of the transaction is rendered.
In the case of conditional sentencing, the amount of the transaction is rendered after deduction of the costs of justice.
The rules of procedure and the terms of payment referred to in this § are laid down by the King.
§ 2.
The amount of the transaction cannot be less than the minimum or exceed the maximum fine for the offence.
In case of offences the amounts of the transactions may be added without that the total amount does not exceed the maximum of the highest fine double.
In case of recidivism within a period of three years after payment of the sum which extinguished public action, the maximum amount of the transaction can be doubled.
The amount of the transactions is increased by the additional decimated that are applicable to the fines provided for in the penal Code.
Article 41A of the Criminal Code applies to the payment of the minimum and the maximum of the amount of the transactions, in the case of offences committed by legal persons.
When the offence under this Act or its orders of execution gave rise to charges of analysis or expertise, the maximum transaction amount determined in accordance with the rules set out in this paragraph may be increased the amount or a portion of these costs. The part of the amount of the transaction to cover these costs will be allocated to the agency or the person who exposed.
§ 3. The person to whom the payment for the transaction is proposed, may, upon request from the concerned official in the § 1, be aware of the dossier for the offence dependants. This person may submit in writing his remarks or means of defenses at the FAMHP, in case of non-payment of the transaction, will forward them to the Prosecutor of the King with the minutes, which finds the infringement.
§
4. The employer is liable for the payment of the transaction proposed to his servant.

§ 5. The amounts resulting from these transactions in the § 1 are paid to the account of the FAMHP in its favour.
§ 6. The FAMHP carries out an internal and external audit for assessment and systematic monitoring of the procedure. ";
2 ° the existing text of § 2 will form the § 7;
3 ° the existing text of § 3 form § 8;
4 ° the existing text of § 4 form § 9.
S. 32. This chapter enter into force at a date to be determined by the King.
TITLE 3. -Contribution to the financing of control of medical devices and traceability Chapter 1. -Definitions art.
33 § 1. For the purposes of this title, is meant by: 1 ° 'official': the FAMHP officer designated by the Minister having health in his attributions for the purposes of this Act;
2 ° "contribution year": each calendar year where the company is active as a Distributor;
3 ° 'distributor': any natural or legal person, with the exception of the retailer, established in the European Union, which provides retailers or end users of the devices;
4 ° "retailer": any natural or legal person who provides features to consumers, namely any natural person who acquires or uses devices exclusively for non-professional purposes;
5 ° "end-user": any physical or legal person, other than a Distributor, which uses a medical device in the context of his professional activities;
6 ° "FAMHP": Federal Agency for medicines and health products;
7 ° 'device': device medical or accessory of a medical device;
8 ° "Minister": the Minister having health in its attributions;
9 ° "turnover of medical devices": turnover as defined under article 92 of the Code of corporations but limited to the part relating to the sale and provision of medical devices as referred to in the 11 °, including medical devices as referred to in the 13 ° and 15 °, retailers and end-users in Belgium;
10 ° "total sales": last known turnover by the company during a taxable period preceding the year of assessment as this period is defined in income taxes;
11 ° "medical device": any instrument, apparatus, appliance, software, any material or other article, whether used alone or in combination, including the software intended by the manufacturer to be used specifically for diagnostic or therapeutic and necessary for the proper functioning, intended by the manufacturer to be used in humans for purposes:-diagnosis, prevention, control treatment or mitigation of a disease, - diagnostic, control, treatment, mitigation or compensation of an injury or disability, - study or replacement or modification of the Anatomy or of a physiological process, - control of the design, with the principal intended action in or on the human body is not achieved by pharmacological or immunological means or by metabolism , but that the function can be assisted by such means;
12 ° "accessory": any item which, not being a device is intended specifically by its manufacturer to be used with a device to allow the use of the device in accordance with the intentions of the manufacturer of the device;
13 ° "implantable medical device": any medical device that is designed to be implemented in whole or in part, by surgical or medical intervention, in the human body or, by medical intervention into a natural orifice, and which is intended to remain after the procedure.
14 ° "professional practitioner": practitioner referred to in article 2, 3 °, of the law of August 22, 2002 on the rights of the patient;
15 ° "diagnostic medical device in vitro": any medical device which is a reagent, reagent product, a calibration material, control material, Kit, an instrument, a device, equipment or a system, used alone or in combination, intended by the manufacturer to be used in vitro in the examination of specimens derived from the human body, including blood and tissue donations only, or primarily for the purpose of providing information:-concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures.
Containers for samples are considered medical diagnostic devices in vitro. Is meant by "receptacles for samples" devices, whether vacuum or not, specifically intended by their manufacturer to directly receive the sample derived from the human body and keep to a review of diagnostic in vitro.
Products for general laboratory use are not diagnostic medical devices in vitro unless, in view of their characteristics, they are specifically intended by their manufacturer diagnostic examinations in vitro.

§ 2. Physical or legal persons following shall retailers for the purposes of this title: 1 ° pharmacies allowed;
2 ° the audiologists and specialists for deliveries to end users on the basis of technical services that can be performed by audiologists and specialists pursuant to article 23, § 1, paragraph 1, of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care;
3 ° bandagers, Orthotists and Prosthetists to deliveries to the end-users on the basis of technical services that can be performed by the bandagers pursuant to article 23, § 1, paragraph 1, of the arrested royal No. 78 of 10 November 1967;
4 ° opticians to deliveries to end users of articles intended for correction or the compensation of the vision of the human being, and artificial eyes.
CHAPTER 2. -Contribution to the financing of control of medical devices Section 1.
-Amount of the annual contribution art. 34. the distributors are liable to an annual contribution of 0,29438% on their turnover of medical devices the previous calendar year on the Belgian market. This contribution cannot be less than EUR 500.
The minimum contribution referred to in paragraph 1 is adapted annually, according to the index of the month of September, to the evolution of the consumer price index. The starting index is the month of September preceding the publication of this Act in the Moniteur belge. Indexed amounts are payable from 1 January of the year following that during which the adaptation was made and shall be published in the Moniteur belge.
Section 2. -Fixing of the article contribution
35. the distributors take a particular journal, organized so that details of transactions of sale, export and services relating to can be followed, showing the amount, mode and day of perception as well as levies in nature other than for their company, as well as the consequences of these transactions for sales of medical devices.
The particular newspaper is held permanently at the disposal of the FAMHP at Headquarters

Office of the Distributor or, if it is different, in the principal place where the activities are carried out. If the Distributor has no seat in Belgium, or is an individual homeless in Belgium, but has one or several antennas and one or several activity centres, provision takes place in the main antenna or the main centre of activities in Belgium, and distributor ensures that this Center is known to the FAMHP.
The Distributor introduced each year before 1 April with the FAMHP a statement of sales of medical devices in the previous calendar year, certified by an auditor or a chartered accountant on the basis of the particular journal.
Until the dispenser is subject or not to the law of 17 July 1975 on accounting companies, articles 6 to 8, the orders of execution thereof, and article 16 of the law of 17 July 1975 apply to holding the particular log and the certification of the turnover.
The King may set a model for the declaration referred to in paragraph 3.
S.
36. the officer may, in the absence of a declaration under article 35 and after application of article 42, office to fix the contribution on the basis of the total turnover of the company.
The amount of the fixed contribution of office is at least 500 euros.
The Distributor referred to in paragraph 1, is informed by registered delivery against acknowledgement of intent to fix office with indication of the existence of the remedy referred to in article 38 and the forms and deadlines to meet.
The Distributor has 15 days to submit his remarks written on the official. Otherwise, intend to become final upon expiry of this period.
The official may reduce turnover which serves as the basis for the establishment of the contribution in accordance with 1st paragraph, in the event of manifest disproportion between the total turnover and the turnover of medical devices, to the extent of this disproportion.
At the request of the staff member, the competent service within the Service public federal Finance delivers the information for the purposes of paragraph 1.
S. 37. the Officer determines the amount of the contribution and fixed it in a decision.
The decision is notified to the Distributor by registered delivery against acknowledgement of receipt, with an indication of the existence of the remedies referred to in article 38 and the forms and deadlines to meet.
S. 38 § 1. Under penalty of forfeiture, the Distributor may introduce, within fifteen days of the expiry of the period referred to in article 36, paragraph 3, or after a final decision referred to in article 37, paragraph 2, a motivated administrative appeal against the decision, with the general administrator of the FAMHP, to a shipment recommended against acknowledgment of receipt. Under penalty of nullity, he joined this sending a copy of the declaration, unless the contribution has been fixed office, and decision and also indicates whether he wishes to be heard.
§ 2. The Deputy Head of the FAMHP or his delegate decides, after hearing the dispenser if requested by the latter in accordance with the § 1.
The decision shall be notified by sending recommended against acknowledgment of receipt.
Section 3. -Collection and recovery article 39. the official sends a notice of payment to the Distributor by sending recommended against acknowledgment of receipt.
The notice of payment listed the amount payable, the method of calculation, by the payment due and the remainder of the proceedings.
If an initial appeal has been lodged in accordance with article 38, the official joined the decision referred to in article 38, paragraph 2, the notice of payment.
S. 40 § 1. The amount of the contribution is paid no later than 14 days after receipt of the notice of payment.
§
2. If payment is not made within the period specified in the § 1, the employee sends the final decision with the amount payable to the federal public Service Finance and money owed is collected by means of constraint, in accordance with article 3 of the national law of December 22, 1949.
Interest equal to the legal rate of interest in tax matters is because of right for the duration of the delay on the sums due.
S. 41. the implementation of the constraint cannot be interrupted by commencing an action in court.
Section 4. -Control and sanctions art.
42. the employee may put the distributor notice to comply with article 35 within a period of 15 days. If Distributor remains in default upon the expiry of this period, the officer may, after having heard or duly summoned the person and having informed her of the fine to which it is exposed, impose an administrative fine. The fine is 1% of the total turnover.
An employee may reduce turnover which serves as a basis for the fixing of the fine pursuant to paragraph 1, in accordance with the principle of proportionality, particularly in the event of manifest disproportion between the total turnover and the turnover of medical devices, to the extent of this disproportion.
At the request of the staff member, the competent service within the Service public federal Finance delivers the information for the purposes of paragraph 1.
The fine is perceived by the Service federal public finance in accordance with section 3.
Section 5. -Procedure and limitation period art. 43. under penalty of forfeiture, the appeal shall be commenced before the expiry of the period referred to in article 40, § 1.
S. 44. the contribution prescribed by five years from the date on which it shall be paid under section 40, § 1.
S.
45. If the distributor does not obligations of notification and registration in violation of Chapter 3, orders taken in execution thereof or the Royal Decrees relating to medical devices under article 1bis of the law of 25 March 1964 on medicines, the official can set the contribution in accordance with this chapter for at least five years of contribution during which the Distributor is exempt from the contribution and preceding the year of the fixing.
Article 44 applies to the claim for contribution for the preceding contribution years under paragraph 1.
Section 6. -Contribution exceptional art. 46. for the year 2014, it introduced a compensatory contribution to charge distributors referred to in article 33 § 1, paragraph 1, 3 °.
The amount of this contribution amounts to 0.09% of the turnover, as taken into account for the purposes of article 34, which was carried out in 2014 and is paid through a deposit, set at 0.09% of the turnover in 2013, and a balance. This balance is the difference between the contribution even and the paid deposit.
The contribution referred to in paragraph 1 is collected by the FAMHP on behalf of the national Institute for sickness and invalidity insurance.
Articles 36 to 41 shall apply for the establishment and the recovery of compensatory contribution provided for in the first paragraph.
Section 7. -Provisions finals s. 47. article 224 of the Act of 12 August 2000 on social, budgetary and diverse provisions is hereby repealed, without prejudice to the compensation of the balance in the § 1/1 and 1/2 of section 224 of the Act.
S. 48. article 191, paragraph 1, 32 °, of the law on compulsory health care and insurance benefits, co-ordinated on 14 July 1994, inserted by the Act of 27 December 2012 and amended by the Act of June 28, 2013 shall be supplemented by the words: "as well as the contributions referred to in article 46 of the law of... for medical devices".
S.
49. This chapter shall enter into force on January 1, 2014.
By way of derogation from article 35, the Distributor may for the contribution year 2014, introduce the certified statement of sales by 2013 of medical devices on the basis of the register which has been taken in accordance with article 224, § 1, paragraph 7, of the law of August 12, 2000, from social, budgetary and diverse provisions.
By way of derogation from article 35, the Distributor may for the contribution year 2014, introduce the certified statement of sales of diagnostic medical devices 2013 in vitro on the basis of a declaration on their honour stating the turnover of the previous calendar year.
CHAPTER 3. -Traceability s. 50. the distributor who offers devices in Belgium, even free of charge, is subject to prior registration with the FAMHP.
The Distributor referred to in paragraph 1 in advance saves specifications of the features it provides to the end user or retailer in Belgium.
The King determines the terms of the records referred to in paragraphs 1 and 2.
S. 51 § 1. The professional practitioner who carries out the implementation, removal or replacement of an implantable medical device communicates the personal data referred to in § 4 to the FAMHP for their registration and preservation in an on the implantable medical devices database, hereinafter referred to as "data bank".
The King determines by Decree deliberated in the Council of Ministers, and after the opinion of the Committee established or designated by him pursuant to article 9, § 4, of the law of 25 March 1964 on medicines, implantable medical devices to which this section applies, on the basis of the risk that they pose to public health and patients.
The King, for the devices referred to in paragraph 2, means a Steering Committee to oversee the development of the technical aspects and

to ensure the use of the data bank in accordance with this Act and the legislation on the protection of privacy. This Steering Committee is composed according to the type of device concerned, doctors or dental practitioners involved in locating, removal or replacement of an implantable medical device. It includes as many members of French expression as expression Dutch-speaking members.
The Committee carries out its duties without prejudice to the powers of the Commission on the protection of privacy and the sectoral Committee of social security and Health established in his breast, as well as without prejudice to the responsibility which is the responsibility of the controller under this Act, Act of 8 December 1992 relative to the protection of privacy with respect to the processing of data personal and their orders for execution.
The King fixed, by order deliberate in Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy, the composition and modalities of operation of the Committee in support, as well as his skills against the responsible for the treatment.
§ 2. The FAMHP is responsible for the processing of personal data referred to in § 4, within the meaning of article 1, § 4, of the aforementioned law of 8 December 1992.
The personal data referred to in § 4 are processed under the control of the Committee in support and responsibility of a physician.
By way of derogation from paragraph 1, when the personal data referred to in § 4 shall be communicated to the NIHDI in pursuance of § 11, the INAMI is the controller for the data which it is entrusted.
§ 3. The treatment of the personal data referred to in § 4 in the data bank pursue the following aims: 1 ° collect the information necessary to enable the authorities and professionals concerned to carry out their tasks in materiovigilance, including identifying incidents and provide follow-up adequate to protect public health;
2 ° collect information necessary for the performance by the competent authorities of this title;
3 ° enable the person concerned and the doctors referred to the §§ 5, 7 and 8 have the most accurate information possible about the nature of the implantable medical device that was implanted in the person concerned;
4 ° collect the information necessary to enable the competent authorities run their missions of protection of public health, and especially allow to have and provide general information on the exposure of the population at risk for materiovigilance;
5 ° to better understand the use of implantable medical devices in Belgium;
6 ° preserve data that could be used as evidence in judicial, administrative or disciplinary proceedings.
Treatment may also involve the identification of the person concerned, in accordance with rules laid down in this article, where necessary in order to provide care or to provide important information for health.
§ 4. The data bank contains the personal following data concerning any person with an implantable medical device has been implanted, hereinafter referred to as "the person concerned": 1 ° the identification of the person concerned, referred to in article 8, § 1, of the Act of 15 January 1990 to the institution and the Organization of a Crossroads Bank for social security. For people who do not have such number, it can be made use of a specific number enabling their identification, determined in a manner defined by the King, by a decree deliberated in the Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy;
2 ° the sex of the person concerned;
3 ° the year of birth of the person concerned;
4 ° the postal code of the residence of the person concerned;
5 ° identification number that has been assigned by the national Institute for sickness and invalidity insurance the physician who proceeded with implementation of the implantable medical device or, in absence of such a number of identification, an other identification number that can identify the doctor in a unique way;
6 ° identification of the institution and the place where the implantation was performed;
7 ° the date of implementation, removal or replacement of the implantable medical device;
8 ° all information to uniquely identify the medical device implanted.
9 ° when necessary taking into account the specific nature of the implantable medical device, an indication relating to the area of the body where it is located.
The King may, in accordance with purposes established in § 3, by Decree deliberated in the Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy add, modify or delete data that is stored in the database.
The additions, changes or deletions are required to ensure an at least equivalent level of protection of public health, patients, users or third parties.
It also determines the system to uniquely identify implanted medical devices.
The data are stored 30 years after the death of the person concerned or 30 years after the time at which the implanted medical device is definitely explanted.
§ 5. Have only access to the personal data referred to in § 4:-the professional practitioner referred to the § 1;
-the doctor or practitioner of Dentistry which is in therapeutic relationship with the patient;
-the person concerned or his legal representative;
Access is allowed through the identification of the person concerned referred to in article 8, § 1, of the above-mentioned Act of 15 January 1990.
§ 6. Notwithstanding § 5, the FAMHP also has access to the data bank data, in accordance with the purposes described in § 3.
Subject to section 8, the FAMHP has however not access to the identity of the person concerned.
For the execution of tasks entrusted to it by this article, the FAMHP has the right to use the identification number of the national register. In cases where the FAMHP is authorized to access the identity of the person concerned, it has access to the data registered in the national register.
§ 7. When the situation is in a State of need, any doctor can also access the personal data referred to in § 4, through the identification of the person concerned referred to in article 8, § 1, of the Act of January 15, 1990, if it considers it necessary for care appropriate to the person concerned.
Doctor who accessed the database in these conditions:-in fact the mention in the patient record referred to in article 9 of the Act of 22 August 2002 on the rights of the patient;
-advises the Steering Committee and the provincial Council of the College of physicians it depends.
§ 8. In the event of serious risk to public health linked to an implantable medical device, or when there is a risk that such a device has resulted or is likely to result in death or serious deterioration in the State of health of a patient, a user or a third party, and that the only reasonable way to remedy this situation requires to identify one or more subjects the FAMHP may proceed to the identification of the person or persons concerned, after the opinion of the Committee for support.
The FAMHP in this case actually a reasoned statement with the National Council of the order of physicians.
The Board may delegate a doctor to monitor the identification.
Only a doctor can make contact with the person concerned, and provide the information required in respect of medical confidentiality.
The King determines, by a decree deliberated in the Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy, the manner in which this identification may take place, the means of communications that can be used on this occasion, and processes which, taking into account the situation and possible urgency, are previously implemented to remedy the situation without this identification.
§ 9. Any other communication from the referred to in § 4 personal data contained in the data bank, not covered by this section or its orders of execution, requires prior approval by the sectoral Committee of social security and health.
§ 10. Security logging is kept for 30 years for each access to the database. This allows identification of persons who have accessed the data referred to in § 4, when, and what data in particular.
§ 11. By way of derogation to the § 1, the King may, by Decree deliberated in the Council of Ministers, and after opinion of the Committee on the protection of private life, determine the cases in which the information referred to in § 4 are supplied by the provider of care to the NIHDI in lieu of the FAMHP, as well as the terms of this communication and the rules of cooperation between the RIZIV and the FAMHP in order to allow the fulfilment by the FAMHP of missions that are entrusted
by this article.
§ 12. The King may, by order deliberate in Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy details of conservation, securing, consultation, communication, and destruction of the data referred to in § 4.


§ 13. The King may, in order to protect public health, by order deliberated in the Council of Ministers, and after opinion of the Committee established or designated by him pursuant to article 9, § 4, of the law of 25 March 1964 on medicines, extend the application of this article to other medical than medical Implantable devices, on the basis of the risk that they pose to public health and patients.
When the King is application of the option provided for in the preceding paragraph, it may adapt laid down under this section to the nature of medical devices, by Decree deliberated in the Council of Ministers, and after receiving the opinion of the Committee on the protection of privacy.
§ 14. To protect public health, the King can establish, by Decree deliberated in the Council of Ministers, and after the opinion of the Committee established or designated by him pursuant to article 9, § 4, of the law of 25 March 1964 on medicines and the Commission for the protection of privacy, the terms of traceability of the medical devices it determines in compliance with the purposes described in § 3, and on the basis of the risk posed by these devices for public health and patients. If it comes to implantable medical devices subject to the obligation of information referred to in the § 1 this paragraph covers the period of life of the medical device prior to implantation. It determines in this context information that are provided by professional practitioners and end users, distributors, as well as how this information is processed. It also specifies the possible links that are made with the information referred to in § 4 contained in the data bank, in respect of the purposes referred to in § 3.
S. 52. the King may, without prejudice to the provisions adopted on the basis of the law of 25 March 1964 on medicines, submit the issue of implantable medical devices by a pharmaceutical pharmacy open to the public or a hospital dispensary to end-users in a notice of withdrawal on behalf of the patient by the end user.
In this case, the King established the model of this declaration of withdrawal, as well as the terms and conditions.
S.
53. for any use of an implantable medical device by a professional practitioner, this last issue the patient information on the device which it is implanted. This information is issued by the Professional on a media practitioner as the patient can keep it and consult it permanently.
On proposal of the Minister having health in its attributions, the King determines the terms of this information, its content and the conditions with which it must comply.
S. 54. the doctors or dental art practitioners who provide care services to patients with implantable medical devices are allowed to keep a repository of medical devices and corresponding medicines such as referred to in article 4, § 4, of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care.
The King may fix the terms and conditions of the authorization referred to in the first paragraph and limit the authorization to the necessary medicines to the benefit referred to in the first paragraph.
S. 55 A article 4 of royal decree No 78 of 10 November 1967 on the exercise of the professions of health care, last amended by the law of December 22, 2008, the following changes are made: 1 ° § 3, 1 °, paragraph 9, is supplemented by the following sentence: "for reasons of public health, there is to hear, among other : 1 ° the sale of drugs and medical devices that have not been obtained in accordance with the legal provisions;
2 ° issuing medicines and devices without taking account of legal provisions relating to traceability. ";
2 ° § 4 is replaced by the following: "§ § 4 4" The physician or practitioner of dentistry authorized to hold a deposit supplies drugs and implantable medical devices either in a pharmaceutical pharmacy open to the public, or in a hospital pharmacy. It cannot deliver these drugs and implantable medical devices as part of a medical procedure.
For the purposes of § 2B, the physician referred to in paragraph 1 enters into an agreement with a holder of a hospital pharmacy or a pharmacy open to the public.
For the purposes of this Act, the filing includes a pharmacy not open to the public. If the agreement referred to in paragraph 2 is reached with a holder of a hospital pharmacy, the deposit is, for the purposes of this Act, also likened to a hospital pharmacy.
If a certificate holder referred to in paragraph 3 does not assume itself responsibility for the pharmaceutical pharmacy, a pharmacist-owner is designated by this holder to assume responsibility for the pharmaceutical dispensary.
Holder who is responsible for the pharmaceutical pharmacy is responsible for the administrative formalities required in the context of the registration procedure, referred to in paragraph 2b, last paragraph.
The King may set terms and conditions for supply, management and control of these deposits that are separated from the doctor's office or other premises where the doctor receives and examines patients, gives them advice or given care."
S. 56. article 6 of the law of 25 March 1964 on medicines, as last amended by the Act of June 20, 2013, is supplemented by a paragraph 3, as follows: "§ § 3 3" Hospital pharmacist may, in the same way as the other pharmacists, issue of drugs and medical devices for the benefit of physicians take a deposit."
S. 57. the King fixed the date of entry into force of each of the articles of this chapter.
Section 53 comes into force for the devices that the King determines the date determined by the King.
Promulgate this Act, order that it be under the seal of the State and published by le Moniteur.
Given in Brussels, December 15, 2013.
PHILIPPE by the King: the Minister of Social Affairs and public health, Beliris and Federal Cultural Institutions, Ms. L. ONKELINX sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ notes Session 2013 - 2014 House of representatives Documents. Bill, no. 53/3057/1. -Amendment, no. 53/3057/2. -Report, no. 53/3057/3. -Text adopted by the commission, no. 53/3057/4. -Text adopted in plenary meeting and transmitted to the Senate, no. 53/3057/5.
Full report: November 7, 2013.