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15 DECEMBER 2013. - Medical Devices Act

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART 1^er. - Introductory provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
PART 2. - Amendments
CHAPTER 1^er. - Amendments to the Insurance Act
health care and allowances, coordinated on 14 July 1994
Section 1^re. - Paramedical Auxiliaries
Art. 2. In section 2, (m), of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, as amended by the Acts of December 24, 1999 and August 22, 2002, the words "that is, people who provide invasive implants or medical devices" are inserted between the words "implant suppliers," and the words "the Licensees".
Section 2. - Health Care Insurance Committee
Art. 3. In section 22 of the Act, last amended by the Act of 27 December 2012, the following amendments are made:
1° in 4° bis, the words "seen to article 27, paragraph 3, and article 29bis, 3°" are replaced by the words "seen to article 27, paragraph 3, to article 29bis, 3°, and to article 29ter, paragraph 4, 3.,".
2° a 4° ter is inserted as follows:
"4° ter. is pronounced in accordance with Article 35septies/3, § 3, on adaptations of the nominative lists of invasive implants and medical devices;"
3° the article is completed by the 19°, written as follows:
"19° concludes the agreements with hospitals referred to in Article 2, n), with respect to invasive implants and medical devices intended for limited clinical applications as defined under Article 35septics/2, § 2, 4°. ".
Section 3. - College of Physicians and Directors
Art. 4. Article 23 of the Act, amended by the Acts of 20 December 1995, 29 April 1996, 22 February 1998, 25 January 1999, 24 December 1999, 22 August 2002, 13 July 2006, 27 December 2006, 18 March 2009, 10 December 2009, 23 December 2009 and 27 December 2012 and the Royal Decree of 25 April 1997, is supplemented by a § 7, which reads as follows:
"§ 7. The College of Physicians and Directors is responsible for deciding on the granting of health benefits under section 34, paragraph 1^er, 4° bis, where this decision constitutes one of the terms and conditions of reimbursement referred to in section 35septies/1, § 2, paragraph 2, 3°, and determine, if any, the amount.".
Section 4. - Special Solidarity Fund
Art. 5. In section 25quater, paragraph 2, (f), of the same law, inserted by the law of 27 April 2005, the words "or the commission referred to in section 29ter" are inserted between the word "competent" and the words "have been seized".
Art. 6. In article 25quinquies, § 4, of the same law, inserted by the law of 27 April 2005 and amended by the law of 27 December 2005, the words "vised 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 benefits in respect of compulsory health care and allowances" are replaced^er4° bis."
Section 5. - Technical advice
Art. 7. In article 27, paragraph 1^er, of the same law, as amended by the laws of 10 August 2001 and 27 December 2005, the words "and a Technical Board of Implants" are repealed.
Section 6. - Reimbursement Commission for Invasive Implants and Medical Devices
Art. 8. In section 29ter of the Act, reinstated by the Act of 13 December 2006 and amended by the Act of 27 December 2006, the following amendments are made:
1° in the Dutch text of paragraph 2, second sentence, the word "invasieve" is inserted between the word "in" and the words "medische hulpmiddelen";
2° in paragraph 4, 1., the words "in section 35septics" are replaced by the words "in sections 35septics/2 and 35septics/3";
3rd paragraph 4, is completed by the 3. to 5.
"3. to make proposals for interpretative rules to the Insurance Committee;
4. to provide advice and advice to the College of Physicians and Directors on the application of a mandatory insurance application for benefits referred to in section 34, paragraph 1^er4° bis, of which they are seized;
5. to make a notice in respect of the benefits of section 34, paragraph 1^er, 4° bis, at the request of the advice referred to in Article 27.".
Section 7. - Health benefits
Art. 9. Article 34, paragraph 1^er, 4° bis, of the same law, inserted by the law of 13 December 2006, the following amendments are made:
1° in (a), the words "with the exception of those covered under 1°, e) including osteo-integrated implants used in dentistry" are replaced by the words "with the exception of those covered under 1°, e), including osteo-integrated implants used in dentistry and invasive implants and medical devices used in the mouth or on the face of which at least one visible or
2° (b) is supplemented by the words ", except those referred to in (a)".
Section 8. - Notification
Art. 10. Article 35septies, § 1^erthe same Act, which was introduced by the Act of 13 December 2006 and amended by the Act of 27 December 2006, is amended as follows:
1° in paragraph 1^er, the words " § 1^er"are repealed;
2° in paragraph 1^er, the word "firm" is replaced by the word "company";
3° in paragraph 3, the words "The firm" are replaced by the words "The company";
Paragraph 8 is replaced by the following:
"The costs of invasive implants and medical devices for long-term unnotified use, which on the basis of this article are not exempt from the notification requirement, cannot in any case be borne by the beneficiaries. These costs also do not come into account for a mandatory insurance intervention, except for devices that come into account for a special solidarity fund intervention. ".
Section 9. - Refund of invasive implants and medical devices
Art. 11. In the same Act, an article 35septies/1 is inserted as follows:
"Art. 35septies/1. § 1^er. List of Refundable Invasive Medical Devices and Implants referred to in section 34, paragraph 1^er, 4° bis, consists of a list of benefits with their terms of reimbursement, referred to as "list", whether or not to these benefits is associated with a nominative list of implants and invasive medical devices, referred to as "named list".
The King sets out the lists referred to in paragraph 1^erno later than six months after this section comes into force.
A nominative list may be associated with benefits that meet one or more of the following conditions:
1° Invasive implant or medical device constitutes an active implantable medical device within the meaning of Council Directive 90/385/EEC of 20 June 1990 concerning the approximation of the laws of the Member States relating to active implantable medical devices or a high-risk device within the meaning of Council Directive 93/42/EEC of 14 June 1993 on medical devices;
2° additional guarantees are provided as to the quality of the implant or invasive medical device;
3° additional guarantees are provided for adequate pricing of the implant or invasive medical device.
§ 2. The list referred to in § 1^erParagraph 1^er, includes the terms of reimbursement determined by the King.
These reimbursements are based on benefits:
1° the reimbursement base;
2° the reimbursement category and subcategory;
3° the conditions of reimbursement;
4° the method of reimbursement, lump sum or non-performing;
5° the security margin, expressed as a percentage of the reimbursement base;
6° the price ceiling.
Invasive implants and medical devices whose selling price A.T.A. included exceeds the ceiling price referred to in paragraph 2, 6°, or the reimbursement base referred to in paragraph 2, 1°, increased from the security margin referred to in paragraph 2, 5°, where it is applied, cannot enter into an account for a mandatory insurance intervention.
In the event of a lump-sum intervention of compulsory insurance, no cost of the device may be considered to the beneficiary.
§ 3. The list referred to in § 1^er reproduces the personal intervention referred to in Article 37, § 2, paragraph 1^er.
§ 4. The name list referred to in § 1^er, includes the data determined by the King for the individual designation of invasive implants and medical devices and the identification of the company.
This nominative list includes useful information to ensure transparency of pricing, including a security margin dependant supplement. ".
Art. 12. In the same Act, an article 35septies/2 is inserted as follows:
"Art. 35septies/2. § 1^er. The list, as defined in Article 35septies/1, § 1^erParagraph 1^er, may be adapted by the Minister on the proposal of the commission referred to in section 29ter:
1° at the request of the company that puts the implant or the invasive medical device on the Belgian market, below referred to as the applicant;
2° at the request of the Minister;
3° at the request of the commission referred to in section 29ter.
§ 2. The adaptations of the list may consist of:
1° in the registration of a benefit;
2° in the modification of a benefit or its terms of refund;
3° by deleting 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 application for adaptation of the list shall be made by the Minister after assessment of one or more of the following criteria by the commission referred to in section 29ter:
1° the therapeutic value of the invasive implant or medical device, expressed in one of the following two classes:
- Class 1: Invasive implants or medical devices with a proven therapeutic or economico-sanitary surplus value compared to existing therapeutic alternatives;
- Class 2: Invasive implants or medical devices that have no proven therapeutic or economico-sanitary surplus value compared to existing therapeutic alternatives;
2° the price of the invasive implant or medical device and the reimbursement base proposed in the application for adaptation;
3° the interest of the invasive implant or medical device in medical practice based on existing therapeutic and social needs;
4° the budgetary impact for compulsory health care insurance;
5° the relationship between the cost for compulsory health care insurance and the therapeutic value.
§ 4. The King may define the criteria referred to in § 3 in a more detailed manner, determine how the class of an invasive implant or medical device is fixed and define in a more detailed manner the criteria referred to in § 3, 2° to 5°, which are at least evaluated according to the class of the implant or the invasive medical device mentioned by the applicant. The King may subdivide classes into subclasses and determine which criteria are specified in § 3, 2° to 5°, which are at least evaluated.
§ 5. In the case of an application for adaptation of the list, introduced by an applicant, on invasive implants or medical devices for long-term use, the commission referred to in section 29ter shall make a final reasoned proposal. The maximum period in which the final reasoned proposal of the commission referred to in section 29ter is made is 180 days and begins to run the day after the day the request for adaptation was declared admissible.
The King sets out the conditions under which the aforementioned 180-day period may be suspended.
Within 45 days of the day after the receipt of the request for accommodation, the secretariat of the commission referred to in article 29ter decides on the admissibility of the application.
If the information provided in support of the request for accommodation is insufficient, the secretariat shall immediately inform the applicant of the detailed additional information that is still required. A further 45 days period begins on the day after the day on which the secretariat of the commission referred to in section 29ter receives the missing information.
The King determines the conditions and conditions under which the applicant is informed of the reasoned decision on the admissibility of the application for accommodation.
The King regulates the terms and conditions of publicity provided by the Health Care Service to requests for adaptation declared admissible.
The secretariat of the commission referred to in section 29ter shall communicate to the applicant the date of admissibility of the request for accommodation.
If the elements attached to the request for accommodation are insufficient after an assessment to be able to formulate a substantiated proposal, the 180-day deadline is suspended and the commission referred to in section 29ter shall promptly inform the applicant what additional elements are still required.
Within 60 days after the receipt of the final reasoned proposal of the commission referred to in section 29ter or of the information that no final reasoned proposal could be made, the Minister shall, after agreement of the Minister who has the Budget in his or her powers, make a reasoned decision regarding the final reasoned proposal of the commission referred to in section 29ter or, in the absence of a final reasoned proposal of the commission referred to in section 29
In the absence of a response from the Minister who has the Budget within 30 days of the application for agreement, his agreement is supposed to be tacit.
The King shall, by order deliberately in the Council of Ministers, determine the conditions and conditions under which the Minister may derogate from the final reasoned proposal of the commission referred to in section 29ter within 60 days referred to in paragraph 9.
If the Minister fails to make a decision within that period, the decision is assumed to be in accordance with the final reasoned proposal of the commission referred to in section 29ter.
If there is no final reasoned proposal from the commission referred to in section 29ter within 180 days and if the Minister has not made a decision within that period, the proposal to adapt the most recent list of the applicant shall be deemed accepted, except in the case referred to in § 7, paragraph 2.
§ 6. The King determines the procedure for requests for adaptation of the list submitted by an applicant, other than those referred to in § 5.
The King also determines the procedure for requests for adaptation of the list that may be introduced at any time by the Minister or the commission referred to in section 29ter.
The Minister decides on requests to adapt the list referred to in paragraph 1^er based on a final reasoned proposal made by the commission referred to in section 29ter.
The Minister shall, after agreement of the Minister who has the Budget in his or her powers, make a reasoned decision on the final reasoned proposal to adapt the list made by the commission referred to in section 29ter.
The King shall determine by order deliberately in the Council of Ministers the terms and conditions under which the Minister may derogate from the final reasoned proposal of the commission referred to in section 29ter.
§ 7. The King determines the procedure whereby the commission referred to in Article 29ter may, in the proceedings referred to in §§ 5 and 6, make a proposal for a temporary reimbursement in the context of a limited clinical application where it considers that the implant or invasive medical device requires an assessment period.
In the absence of a final reasoned proposal for temporary reimbursement in the context of a limited clinical application of the commission referred to in section 29ter and if the Minister has not made a decision, the request for adaptation of the list shall be closed by the secretariat of the commission referred to in section 29ter.
However, in respect of the procedure with delay, in the absence of a final reasoned proposal for temporary reimbursement in the context of a limited clinical application of the commission and prior to the Minister's decision, the applicant may communicate to the Minister his wish to enter into a contract with the Institute, which provides compensation rules for compulsory health care and allowances insurance, as well as the elements on which insecurity still prevails and for which the applicant must perform a contract within the time frame.
The King sets by order deliberately in the Council of Ministers the conditions and rules that such a contract may be concluded between the applicant and the Institute.
The King shall determine the procedure for the assessment period referred to in paragraph 1^er.
§ 8. The King may determine in more detail the procedures referred to in paragraphs 5 to 7, in particular with respect to the composition and content of requests for adaptation and counter-proposals made by the applicant, as well as the computation and suspension of time limits and the conditions to which the applicant is deemed to have distracted from his request for accommodation.
§ 9. The King may extend to other invasive medical devices the procedure and deadlines referred to in § 5.
§ 10. The Minister's decision on requests to adapt the list submitted by an applicant is limited in its scope to the content of this application, unless the decision does not affect the existing rights of the other companies concerned. ".
Art. 13. In the same law, an article 35septic/3 is inserted as follows:
"Art. 35septies/3. § 1^er. A nominative list, as referred to in Article 35septics/1, § 1^er, may be adapted by the Insurance Committee on the proposal of the commission referred to in section 29ter:
1° at the request of the company that puts the implant or the invasive medical device on the Belgian market, below referred to as the applicant;
2° at the request of the Minister;
3° at the request of the commission referred to in section 29ter.
§ 2. Adaptations of a nominative list may consist of:
1° in the registration of an individual implant or an individual invasive medical device under an existing benefit with its reimbursement terms, previously defined on the list;
2° by removing an individual implant or an individual invasive medical device;
3° by modifying one or more of the factual data determined by the King.
§ 3. The decision on the application for adaptation of a nominative list is taken by the Insurance Committee 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 to an applicant's request is limited in its scope to the content of the application for adaptation.".
Art. 14. In the same Act, an article 35septies/4 is inserted as follows:
"Art. 35septies/4. The King may, for the decisions of the Minister or the Insurance Committee that He determines, set out the terms and conditions for the publication of these decisions using the Internet network at http://inami.fgov.be, as well as the terms and conditions under which the Institute's Health Care Service makes technical adjustments to the list or a nominative list. ".
Art. 15. In the same law, an article 35septies/5 is inserted as follows:
"Art. 35septies/5. § 1^er. The Minister's decision on a request for adaptation of the list comes into force on the date fixed by the departmental order confirming that decision.
Derogation from paragraph 1^er, in the event of a positive decision of the Minister for the registration of a benefit on the list, as referred to in section 35septies/2, §§ 5 to 7, or if the Minister is assumed to have confirmed a final reasoned proposal for the registration of a benefit on the list of the commission referred to in section 29ter, the Minister's decision enters into force on the first day of the month following the one in which the decision was published via the internet friend
Derogation from paragraph 1^er, also comes into force on the first day of the month following the one in which it is published using the internet network at http://inami.fgov.be, the most recent proposal of the applicant that is deemed accepted in accordance with section 35septies/2, § 5, paragraph 13, provided that it relates to the listing of a benefit.
§ 2. The decision of the Insurance Committee on an application for adaptation of a nominative list comes into force on the first day of the month following the one in which the decision was published via the Internet network at http://inami.fgov.be
§ 3. Publication of decisions using the internet network referred to in § 1^er, paragraph 2, and § 2 shall intervene no later than 30 days after the adoption of these decisions. ".
Art. 16. In the same Act, an article 35septies/6 is inserted as follows:
Article 35septies/6. The Minister may, on an annual basis, proceed in full and without taking into account the procedural rules referred to in this Act when the list and the lists of names are republished, without making any changes to the content.
The Minister shall, in full right, adapt the nominative lists following the amendments made with respect to the margin of issue referred to in section 44, § 1^erParagraph 3.
The King may determine the cases in which the Institute's Health Care Service may propose adjustments to the list to the Minister or the nominative lists to the Insurance Committee without intervention of the commission referred to in section 29ter in the event of technical corrections of errors. ".
Section 10. - Personal intervention
Art. 17. In section 37 of the Act, last amended by the Act of 19 March 2013, the following amendments are made:
1° in § 2, paragraph 3, the words "as well as the list and the nominative lists of implants and repayable invasive medical devices" are inserted between the word "refundable" and the words "in respect of the amount of personal intervention";
2° in § 14ter, paragraph 3 is repealed.
Art. 18. In article 37sexies, paragraph 5, inserted by the law of 27 December 2005 and amended by the law of 24 July 2008, the words "the surcharge dependant of the beneficiary as a margin of security, as defined in article 35, § 4, and in article 35 bis, § 4, of the nomenclature of health benefits" are replaced by the words "the surcharge dependant of the beneficiary as a margin of security, as defined in article 35, §
Section 11. - Convention Commission
Art. 19. Article 44, § 1^erthe same Act, as amended by the Acts of 20 December 1995, 22 February 1998 and 19 December 2008, the following amendments are made:
1° in paragraph 1^er, the words "providers, devices and implants" are replaced by the words "providers and devices";
2° the § is supplemented by a paragraph written as follows:
"In respect of benefits under section 34, paragraph 1^er, 4° bis, the Convention Commission between implant suppliers and insurers is competent to set the margin of issue. The margin of delivery covers information by the hospital pharmacist to the facilities referred to in section 2, n), and potential implanters on the reimbursement of invasive implants and medical devices. The margin of delivery also covers the purchase, stock management, sterility and delivery of these invasive medical implants and devices, as well as, in accordance with legal requirements, the dispensation and monitoring of the journey through these invasive medical devices and implants. ".
Section 12. - Section XVIbis
Art. 20. In Title III, Chapter V, of the same Law, a section XVIbis is inserted entitled: "Section XVIbis - Companies' obligations for admission to the reimbursement of invasive implants and medical devices referred to in Article 34, paragraph 1^er4° bis.
Art. 21. In section XVIbis, inserted by section 20, an article 75bis is inserted, as follows:
"Art. 75bis. § 1^er. Until the entry into force of the decision to reimburse invasive implants or medical devices for which an application for adaptation of the list or a nominative list has been introduced, all modifications that relate to or may relate to the devices concerned and to the operation of the company and that are useful for the processing of the application are immediately brought to the attention of the company to the relevant section of the commission.
§ 2. As part of compulsory health care insurance and subject to other legal provisions, as of the coming into force of the decision on the repayment of invasive implants or medical devices, the company complies with the following obligations, which are included in the application forms established by the King:
1° ensure 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 of the withdrawal of the Belgian market from the implant or invasive medical device;
3° communicate the number of invasive repayable implants or medical devices that were distributed on the Belgian market the previous year;
4° immediately communicate to the secretariat of the commission referred to in section 29ter any modification of any of the elements of the application for adaptation;
5° immediately communicate the information requested to it in the event of an application for adaptation of the list or a nominative list introduced on the initiative of the Minister or the commission referred to in section 29ter;
6° immediately communicate any undesirable malfunction or side effects of the implant or invasive medical device to the secretariat of the commission referred to in section 29ter;
7° take the necessary measures according to the existing warranty conditions to adequately cover the health damage suffered that results directly from an undesirable malfunction or side effect of the implant or invasive medical device.
The King shall determine the time limit for which it must be satisfied with the communication requirement referred to in paragraph 1^erThree. It may determine for which invasive medical implants or devices it may be derogated from the communication requirement referred to in paragraph 1^erThree.
§ 3. When a company that puts an invasive implant or medical device on the Belgian market wishes to permanently withdraw the repayment of this invasive implant or medical device and continues to put on the Belgian market the implant or invasive medical device, it introduces to this effect a request for the deletion of the list or the nominative list of repayable invasive implants and medical devices referred to in article 35septies/1, § 1^er.
The Minister may, for reasons related to public health or social protection, reject the application for deletion.
The King sets out the procedures for the removal of invasive implants or medical devices and the effective date of this removal.
§ 4. As part of the procedures referred to in sections 35septies/1 to 35septies/6, the company shall forthwith communicate to the secretariat of the commission referred to in section 29ter any useful data requested for the decision-making by the Minister or the Insurance Committee.
§ 5. In order to ensure compliance with the obligations provided for in this Article and without prejudice to the provisions it has adopted, the King shall determine, at the end of the two-year period provided for in the assessment of the reimbursement system, procedures and procedures, the conditions and procedures that the breaches of the undertakings to their obligations, recognized by the secretariat of the commission referred to in Article 29ter may give rise, after prior warning, to a penalty.
These conditions and procedures are, inter alia, determined on the basis of the seriousness of the breach, recidivism and consequences of the sanction for insured persons. ".
Section 13. - Abrogatory provisions
Art. 22. Article 54 of the Act of 13 December 2006 on various health provisions is repealed, except as it inserts section 35s, § 1^er, the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994.
Sections 56 and 57 of the Act of 13 December 2006 are repealed.
Section 14. - Entry into force and transitional provisions
Art. 23. This chapter comes into force on 1^er July 2015.
The King may fix an effective date prior to that referred to in paragraph 1^er.
The King shall determine the transitional provisions applicable to applications filed before the effective date.
CHAPTER 2. - Hospitals and other care facilities
Art. 24. In section 102 of the Coordinated Act of 10 July 2008 on hospitals and other care facilities, the following amendments are made:
1° the 4° is replaced by the following:
"4° the costs of implants referred to in article 34, paragraph 1^er, 4° bis, (a), of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, with the exception of:
(a) Implants subject to the reporting obligation, pursuant to section 35s of the Act, and not being notified;
(b) Implants exempted by the King from the obligation to notify pursuant to section 35septies, paragraph 5, of the same Act and which are not subject to mandatory insurance intervention in accordance with the terms and conditions of reimbursement established;
(c) tissue adhesives, anti-adhesive glues and hemostatic products when they are not subject to compulsory insurance intervention in accordance with the terms and conditions of reimbursement established;
(d) implants that cannot be considered for effective intervention of compulsory insurance under section 35 septies/1, § 2, paragraph 3, of the Act;
(e) implants that have been the subject of a negative decision of the Minister following a negative assessment of the commission referred to in section 29ter of the same law, carried out in accordance with section 35septies/2, § 3, of the same law or a negative decision of the Insurance Committee following a negative assessment of the aforementioned commission, carried out in accordance with section 35septies/3, § 3 of the same law.";
2° in 5°, the words "in the conditions" are replaced by the words "in accordance with the terms".
Art. 25. Section 24 comes into force on 1^er July 2015.
The King may fix an effective date prior to that referred to in paragraph 1^er.
Art. 26. By derogation from section 60 of the Act of 13 December 2006 on various health provisions, section 59, 2°, of the Act comes into force on 1 December 2006^er July 2015.
The King may fix an effective date prior to that referred to in paragraph 1^er.
CHAPTER 3. - Amendments to the law
25 March 1964 on Drugs
Art. 27. Article 9, § 4, of the Law of 25 March 1964 on Drugs, inserted by the Law of 27 April 2005, is supplemented by three paragraphs, as follows:
"For public health protection purposes, the King may extend the advertising prohibition referred to in paragraph 1^er other medical devices than implantable medical devices. To this end, the King shall establish a commission to advise the Minister or his or her delegate on the risk that a medical device may represent for public health.
The King sets out the composition and operating procedures of the commission.
By derogation from paragraph 5, the King may entrust an existing body with an expert opinion, which has the necessary experience with medical devices, with the issuance of notice referred to in paragraph 1^er"
Art. 28. In article 14, § 3, of the same law, replaced by the law of 22 December 2003, a paragraph written as follows is inserted between paragraphs 3 and 4:
"The original record is sent to the designated officer pursuant to Article 17, § 1^er of this Act."
Art. 29. In the same law, an article 16bis is inserted as follows:
"Art. 16bis. § 1^er. By derogation from article 16 and without prejudice to penalties commuted by the Criminal Code:
1° shall be punished by imprisonment of eight days to one month and a fine of EUR 100 to EUR 1,000 or only one of these penalties, which contravenes the orders taken pursuant to Article 1^erbis of this Law;
2° by derogation from 1°, is punishable by imprisonment from one month to one year and a fine of EUR 200 to EUR 15,000 or only one of these penalties:
(a) contravenes section 3, of the Medical Devices Act or the Orders pursuant to that chapter;
(b) in any capacity, puts into service, distributes, acquires or uses a medical device in any way under conditions that it knows or must know that they are in contradiction with the specific legal rules of distribution established for this medical device;
(c) distributes, acquires or uses, in any capacity, a medical device to which he or she knows or must know that he or she does not comply with the provisions established by or under heading 3, chapter 3, of the Medical Devices Act, or with orders made pursuant to that chapter.
§ 2. By derogation from § 1^er, is punished by imprisonment of one to three years and a fine of EUR 1,000 to EUR 10,000 or only one of these penalties, which:
1° unduly applies a marking of conformity intended for medical devices on an instrument, device, equipment, material or any other article in order to facilitate its marketing, commissioning, circulation or use in any capacity;
2° imports, puts on the market, puts in service, lets circulate or uses in any capacity an instrument, device, equipment, material or any other article on which a marking of conformity for medical devices is unduly affixed within the meaning of 1° while it knows or should know the undue character of this marking;
3° imports, puts on the market, puts in service, lets circulate or uses in any capacity either an instrument, device, equipment, material or any other article without marking of conformity for medical devices while it knows or should know that such marking is mandatory;
4° is the manufacturer or agent of a manufacturer and is not made available or does not provide the FAMPS with any declarations of conformity or technical documentation of medical devices that it imports, puts on the market or puts in service;
5° contravenes section 9, § 4, of this Act or the enforcement orders of this Act;
§ 3. It is also punishable by imprisonment of one to three years and a fine of EUR 1,000 to EUR 10,000 or only one of these penalties:
1° for the manufacturer, importer or distributor of a device, to have been aware of an incident or risk of an incident involving a medical device that has resulted in or likely to result in the death or serious deterioration of the health condition of a patient, user or third party, and to refrain from reporting it promptly to the PSMPS;
2° for the health professional, to have personally known, in the performance of his duties, an incident or a risk of incident of the same nature, and to refrain from reporting it promptly to the PSMPS.
FAMPS sets out the terms and conditions for how notifications referred to in paragraph 1^er are operated and published on its website. AFMPS may make it mandatory to use a form. "
Art. 30. In Article 16, § 3, 1°, of the same law, last amended by the law of 20 June 2013, the words "of Article 9" are replaced by the words "of Article 9, §§ 1^er at 3,"
Art. 31. In section 17 of the Act, last amended by the Act of 27 December 2006, the following amendments are made:
1° § 1^er is replaced by the following:
§ 1^er. In the event of an offence under title 3, chapter 3, of the Law of ... in respect of medical devices or the orders made pursuant to this chapter, the grievor, holder of the doctorate degree, licence or master in law, designated for that purpose by the Administrator General of the AFMPS, transmits a copy of the record of finding of offence, for information, to the Crown Prosecutor.
The designated official based on paragraph 1^er may propose to the offender a transaction whose payment extinguishes public action pursuant to paragraph 6.
The transaction referred to in paragraph 2 is sent to the offender within three months of the date of the report. A copy of this proposal is transmitted to the King's Prosecutor for information.
In case of payment of the transaction, the employee designated on the basis of paragraph 1^er of this paragraph shall immediately notify the Crown Prosecutor by registered mail. A copy of this notification is sent to the offender by registered mail.
In the event of non-payment of the transaction, the minutes are forwarded to the King's Prosecutor.
If no transaction proposal is made by the designated official based on paragraph 1^er, the latter shall forward the minutes to the Crown Prosecutor within three months of the date of the minutes.
The payment of the transaction extinguishes the public action, unless the King's Attorney notifies the perpetrator of the offence within one month of the notification of the payment referred to in paragraph 4, that he intends to exercise that action. The notification shall be made by registered mail.
If the public action is introduced after payment of the transaction and results in the conviction of the interested party, the amount of the transaction is then charged to the legal costs due to the State and the fine imposed. The potential surplus is returned. In case of acquittal, the amount of the transaction is returned.
In the event of a conditional conviction, the amount of the transaction shall be returned after deduction of court fees.
The rules of procedure and the terms of payment referred to in this § shall be fixed by the King.
§ 2. The amount of the transaction may not be less than the minimum nor exceed the maximum fine set for the offence.
In the event of an infringement contest, the amounts of the transactions may be added without the total amount exceeding the maximum of the maximum fine.
In case of recidivism within three years after payment of the sum that extinguishes the public action, the maximum amount of the transaction can be doubled.
The amount of transactions is increased by additional decimals that are applied to fines provided for in the Penal Code.
Section 41bis of the Criminal Code applies to the payment of the minimum and maximum amount of transactions, in the event of offences committed by legal persons.
Where the offence of this Act or its enforcement orders has given rise to analytical or expert fees, the maximum amount of the transaction determined under the rules set out in this subsection may be increased by the amount or part of the amount of the transaction. The portion of the transaction amount to cover these costs will be allocated to the organization or to the person who exposed them.
§ 3. The person to whom the payment of the transaction is proposed may, upon request from the employee referred to in § 1^er, take note of the file concerning the charge offence. This person may send written notices or defences to the PSMPS, which, in the event of non-payment of the transaction, will forward them to the King's Attorney with the minutes which notices the offence.
§ 4. The employer is civilly responsible for the payment of the proposed transaction to its employee.
§ 5. The sums resulting from the transactions referred to in § 1^er are paid to the FAMPS account for its benefit.
§ 6. The PSMPS conducts an internal and external audit for a systematic evaluation and monitoring of the procedure. ";
2° the current text of § 2 shall form § 7;
3° the current text of § 3 shall form § 8;
4° the current text of § 4 will form § 9.
Art. 32. This chapter comes into force on a date to be determined by the King.
PART 3. - Contribution to funding
control of medical devices and traceability
CHAPTER 1^er. - Definitions
Art. 33. § 1^er. For the purposes of this title:
1° "staff": the official of the PSMPS designated by the Minister who has Public Health in his duties for the purposes of this Act;
2° "year of contribution": each calendar year in which the company is active as a distributor;
3° "distributor": any natural or legal person, except the retailer, established in the European Union, who makes available to retailers or end users of the devices;
4° "dead": any natural or legal person who provides devices to consumers, i.e. any natural person who acquires or uses devices exclusively for non-professional purposes;
5° "final user": any natural or legal person, other than a distributor, who uses a medical device as part of his or her professional activities;
6° "AFMPS": Federal Agency for Drugs and Health Products;
7° "dispositive" : medical device or accessory of a medical device;
8° "Minister": the Minister who has Public Health in his duties;
9° "Business of medical devices": turnover as defined under section 92 of the Code of Companies but limited to the part relating to the sale and provision of medical devices as referred to in 11°, including medical devices as referred to in 13° and 15°, retailers and end-users in Belgium;
10° "total business figures": the last known turnover made by the company during a taxable period preceding the contribution year as defined in the income tax period;
11° "medical device": any instrument, device, equipment, software, any material or any other article, used alone or in association, including the software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes, and necessary for the proper operation of it, intended by the manufacturer to be used in man for the purposes of:
- diagnosis, prevention, control, treatment or mitigation of a disease,
- diagnosis, control, treatment, mitigation or compensation of an injury or disability,
- study or replacement or modification of anatomy or physiological process,
- design control,
and whose primary action in or on the human body is not obtained by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means;
12° "accessory": any article which, being not a device, is specifically intended 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 this device;
13° "implantable medical device": any medical device that is designed to be implanted in whole or in part, by surgical or medical intervention, in the human body or, by medical intervention, in a natural orifice that is intended to remain there after the intervention;
14° "professional practitioner": practitioner referred to in section 2, 3°, of the Act of 22 August 2002 on the rights of the patient;
15° "In vitro diagnostic medical device": any medical device that consists of a reagent, reactive product, calibration material, control material, kit, instrument, device, equipment or system, used alone or in combination, intended by the manufacturer to be used in vitro in the examination of samples from the human body, including donations of blood and tissue, only to provide or
- concerning a physiological or pathological state, or
- for congenital anomaly, or
- to determine safety and compatibility with potential receivers, or
- to control therapeutic measures.
Sample containers are considered to be in vitro diagnostic medical devices. The "sample collection" means devices, whether vacuumed or not, specifically intended by their manufacturer to receive directly the sample from the human body and to store it for an in vitro diagnostic examination.
Products intended for general laboratory use are not in vitro diagnostic medical devices unless, given their characteristics, they are specifically intended by their manufacturer for in vitro diagnostic tests.
§ 2. The following natural or legal persons are entitled to complete retailing for the purposes of this title:
1° licensed pharmaceuticals;
2° audiologists and audicians for deliveries to end users on the basis of technical services that can be performed by audiologists and audicians pursuant to Article 23, § 1^erParagraph 1^er, Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions;
3° bandagists, orthists and prothesists for deliveries to end users on the basis of technical services that can be performed by bandagists under Article 23, § 1^erParagraph 1^erthe same Royal Decree No. 78 of 10 November 1967;
4° opticians for deliveries to end users of articles intended for the correction or compensation of the vision of human being, and artificial eyes.
CHAPTER 2. - Contribution to funding
control of medical devices
Section 1^re. - Amount of annual contribution
Art. 34. Distributors are responsible for an annual contribution of 0.29438% on their turnover of medical devices realized the previous calendar year in the Belgian market. This contribution cannot be less than 500 euros.
The minimum contribution referred to in paragraph 1^er is adapted annually, depending on the September index, to the evolution of the Consumer Price Index. The starting index is that of September prior to the publication of this Act to the Belgian Monitor. The indexed amounts are published in the Belgian Monitor and are due from 1^er January of the year following that during which the adaptation was made.
Section 2. - Determination of contribution
Art. 35. Distributors hold a specific newspaper, organized so that the details of the sales, export and services provided for the devices can be followed, indicating the amount, mode and day of the collection, as well as in kind other than for their business, as well as the consequences of these transactions for the turnover of medical devices.
The particular newspaper is kept at the disposal of the AFMPS at the distributor's headquarters or, if different, at the main place where the activities are carried out. If the distributor does not have a seat in Belgium, or is a natural person without a home in Belgium, but has one or more antennas or one or more activity centers, the layout takes place in the main antenna or main activity center in Belgium, and the distributor ensures that the address of this center is known to the AFMPS.
Distributor introduces each year before 1^er April with the AFMPS a statement of the turnover of medical devices of the previous calendar year, certified by a reviewer or an accountant based on the particular newspaper.
Whether or not the distributor is subject to the Act of 17 July 1975 on business accounting, sections 6 to 8, enforcement orders, and section 16 of the aforementioned Act of 17 July 1975 apply to the holding of the particular newspaper and to the attestation of sales.
The King may set a model for the declaration referred to in paragraph 3.
Art. 36. The employee may, in the absence of a statement made pursuant to section 35 and after application of section 42, determine the contribution on the basis of the total turnover of the business. The amount of the fixed contribution is at least 500 euros.
The distributor referred to in paragraph 1^er, is notified by registered consignment against acknowledgement of receipt of the intention of the binding with indication of the existence of the remedy referred to in article 38 as well as the forms and deadlines to be respected.
The distributor has fifteen days to submit his written remarks to the grievor. Otherwise, the intent becomes final at the expiry of this period.
The employee may reduce the turnover that serves as the basis for determining the contribution in accordance with paragraph 1^erin the event of a manifest disproportion between the total turnover and the turnover of medical devices, to the extent of this disproportion.
At the request of the grievor, the appropriate department within the Federal Public Service Finance shall issue information for the purposes of paragraph 1^er.
Art. 37. The staff member determines the amount of the contribution and sets it in a decision.
The decision shall be notified to the distributor by registered consignment against acknowledgement of receipt, indicating the existence of the remedy referred to in section 38 as well as the forms and deadlines to be respected.
Art. 38. § 1^er. Upon termination, the distributor may, within fifteen days after the expiry of the period referred to in section 36, paragraph 3, or after a final decision referred to in section 37, paragraph 2, file an administrative appeal against the decision with the deputy head of the PSMPS by a registered consignment against receipt. In the event of a nullity, he shall attach a copy of the statement to that consignment, unless the contribution has been fixed ex officio, and the decision and also indicate whether he wishes to be heard.
§ 2. The deputy head of the AFMPS or his delegate decides, after hearing the distributor if the distributor requested it in accordance with § 1^er.
The decision is served by registered mail against receipt.
Section 3. - Loss and recovery
Art. 39. The grievor sends a notice of payment to the distributor by registered mail against receipt.
The notice of payment mentions the amount to be paid, the method of calculation, the maturity of payment and the continuation of the procedure.
If an initial appeal has been filed in accordance with section 38, the grievor shall attach the decision referred to in section 38, § 2, to the notice of payment.
Art. 40. § 1^er. The amount of the contribution is paid no later than 14 days after receipt of the notice of payment.
§ 2. If the payment is not made within the period referred to in § 1^er, the grievor sends the final decision with the amount to be paid to the Federal Public Service Finance and the amounts due are recovered by constraint, in accordance with section 3 of the federal law of December 22, 1949.
An interest equal to the legal interest rate in tax matters is due in full right for the duration of the delay in the amounts due.
Art. 41. Enforcement of constraint can only be interrupted by bringing an action to justice.
Section 4. - Monitoring and sanctions
Art. 42. The grievor may restrain the distributor from complying with section 35 within 15 days. If the distributor remains in default on the expiry of this period, the grievor may, after hearing or duly summoned the person and having informed him of the fine to which he or she is exposed, make an administrative fine to him or her. The fine is 1% of total revenue.
The grievor may reduce the turnover that serves as the basis for fixing the fine in accordance with paragraph 1^er, in accordance with the principle of proportionality, in particular in the event of a manifest disproportion between the total turnover and the turnover of medical devices, to the extent of this disproportion.
At the request of the grievor, the appropriate department within the Federal Public Service Finance shall issue information for the purposes of paragraph 1^er.
The fine is collected by the Federal Public Service Finance in accordance with Section 3.
Section 5. - Procedure and prescription
Art. 43. The appeal shall be filed before the expiry of the period referred to in Article 40, § 1^er.
Art. 44. The contribution is prescribed by five years from the date on which it must be paid under Article 40, § 1^er.
Art. 45. If the distributor fails to comply with its obligations of notification and registration in contravention of Chapter 3, orders made pursuant to Chapter 3 or royal decrees relating to medical devices under Article 1^erbis of the Act of March 25, 1964 on Drugs, the grievor may determine the contribution in accordance with this chapter for a maximum of five years of contribution during which the distributor has subtracted from the contribution and before the year of the fixing.
Section 44 applies to the claim of the contribution set for the preceding contribution years pursuant to paragraph 1^er.
Section 6. - Exceptional contribution
Art. 46. For the year 2014, a compensatory contribution is introduced to the distributors referred to in Article 33, § 1^erParagraph 1^erThree.
The amount of this contribution is 0.09 per cent of the turnover, as reflected in the application of section 34, which was made in 2014 and is paid through a deposit, set at 0.09 per cent of the turnover in 2013, and a balance. This balance is the difference between the contribution itself and the deposit paid.
The contribution referred to in paragraph 1^er is collected by the AFMPS on behalf of the National Institute of Disability Health Insurance.
Sections 36 to 41 apply to the establishment and recovery of the compensatory contribution referred to in paragraph 1.
Section 7. - Final provisions
Art. 47. Article 224 of the Act of 12 August 2000 on social, budgetary and other provisions is repealed, without prejudice to compensation for the balance referred to in § 1^er/1 and § 1/2 of Article 224 of the same Law.
Art. 48. Article 191, paragraph 1^er32°, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, inserted by the Act of 27 December 2012 and amended by the Act of 28 June 2013 is supplemented by the words:
"as well as the contributions referred to in Article 46 of the ... Medical Devices Act."
Art. 49. This chapter comes into force on 1^er January 2014.
By derogation from section 35, the distributor may, for the 2014 contribution year, introduce the certified return of the 2013 turnover of medical devices on the basis of the register that was held in accordance with Article 224, § 1^erparagraph 7 of the Act of 12 August 2000 of social, budgetary and other provisions.
By derogation from section 35, the distributor may, for the 2014 contribution year, introduce the certified return of the 2013 turnover of in vitro diagnostic medical devices on the basis of a statement on honour indicating the turnover of the previous calendar year.
CHAPTER 3. - Traceability
Art. 50. The distributor who makes devices available in Belgium, even free of charge, is subject to a prior registration with the AFMPS.
The distributor referred to in paragraph 1^er first records the specifications of the devices it provides to the end user or retailer in Belgium.
The King shall determine the terms and conditions of the registration referred to in paragraph 1^er and 2.
Art. 51. § 1^er. The professional practitioner who initiates the establishment, withdrawal or replacement of an implantable medical device shall communicate the personal data referred to in § 4 to the AFMPS for registration and retention in a data bank for implantable medical devices, referred to as "the data bank".
The King shall determine by order deliberately in the Council of Ministers, and after notice of the commission established or designated by him pursuant to section 9, § 4, of the Act of 25 March 1964 on medicines, the implantable medical devices to which this section applies, on the basis of the risk that they represent for public health and patients.
The King, for the devices referred to in paragraph 2, designates an accompanying committee to oversee the development of technical aspects and to ensure the use of the data bank in accordance with this Act and the privacy legislation. This accompanying committee is composed, depending on the type of device concerned, of doctors or dental practitioners involved in the establishment, removal or replacement of an implantable medical device. It includes as many French-speaking members as Dutch-speaking members.
The Committee shall carry out its duties without prejudice to the competence of the Privacy Commission and the Sectoral Committee on Social Security and Health established within it, and without prejudice to the responsibility of the person responsible for processing under this Act, Act of 8 December 1992 on the protection of privacy with respect to personal data processing and their enforcement orders.
The King sets out, by order deliberately in the Council of Ministers, and after the advice of the Commission on the Protection of Privacy, the composition and operating procedures of the accompanying committee, as well as its competence with respect to the controller.
§ 2. AFMPS is the person responsible for processing personal data referred to in § 4, within the meaning of Article 1^er§ 4 of the above-mentioned Act of 8 December 1992.
The personal data referred to in § 4 are processed under the supervision of the accompanying committee and the responsibility of a doctor.
Derogation from paragraph 1^erwhere the personal data referred to in § 4 are communicated to INAMI pursuant to § 11, INAMI is the controller for the data entrusted to it.
§ 3. The processing of personal data referred to in § 4 in the data bank continues the following purposes:
1° collect the necessary information to enable the authorities and professionals concerned to carry out their materiality tasks, including identifying incidents, and providing adequate monitoring to protect public health;
2° collect the information necessary for the execution by the competent authorities of this title;
3° allow the person concerned and the doctors referred to in §§ 5, 7 and 8 to have the most accurate information possible on the nature of the implantable medical device that was implanted in the person concerned;
4° collect the necessary information to enable the competent authorities to carry out their public health protection missions, including providing and communicating general information on the exposure of the population to a risk of materiality;
5° to better know the use of implantable medical devices in Belgium;
6° keep the data that could be used as evidence in judicial, administrative or disciplinary proceedings.
The treatment may also relate to the identification of the person concerned, in accordance with the rules set out in this section, where necessary to provide care or to provide him with important information for his or her health.
§ 4. The data bank contains the following personal data concerning any person in whom an implantable medical device has been established, referred to as "the person concerned":
1° the identification number of the data subject, referred to in Article 8, § 1^er, of the Act of January 15, 1990 on the institution and organization of a Social Security Bank. For persons who do not have such a number, a specific number may be used which allows their identification, determined in terms defined by the King, by a deliberate order in the Council of Ministers, and after the advice of the Privacy Commission;
2° the sex of the person concerned;
3° the year of birth of the data subject;
4° the postal code of the domicile of the data subject;
5° the identification number that was assigned by the National Institute of Disability Health Insurance to the physician who proceeded to the establishment of the implantable medical device or, in the absence of such an identification number, another identification number that can identify the physician in a single manner;
6° the identification of the institution and the place where the establishment was executed;
7° the date of the establishment, withdrawal or replacement of the implantable medical device;
8° all information to uniquely identify the implanted medical device;
9° where necessary given the specific nature of the implantable medical device, an indication of the location of the body where it is located.
The King may, in accordance with the purposes set out in § 3, by order deliberately in the Council of Ministers, and after the opinion of the Commission on the Protection of Privacy add, modify or delete the data that is registered in the data bank. Additions, modifications or removals are necessary to ensure at least equivalent levels of public health protection, patients, users or third parties.
It also determines the system for unique identification of implanted medical devices.
The data is retained 30 years after the death of the data subject or 30 years after the time at which the medical device is permanently exposed.
§ 5. Only access to the personal data referred to in § 4:
- the professional practitioner referred to in § 1^er;
- the doctor or dental art practitioner who is in therapeutic relationship with the patient;
- the person concerned or his legal representative;
Access is authorized by means of the identification number of the data subject to Article 8, § 1^erthe Act of 15 January 1990 referred to above.
§ 6. By derogation from § 5, AFMPS also has access to data from the data bank, in accordance with the purposes described in § 3.
Subject to § 8, AFMPS does not have access to the identity of the person concerned.
For the performance of the missions entrusted to it by this section, the PSMPS has the right to use the National Register ID number. In cases where the PSMPS is authorized to access the identity of the data subject, it has access to the data recorded in the National Registry.
§ 7. When the situation arises from a state of necessity, a doctor may also access the personal data referred to in § 4, by means of the identification number of the data subject to Article 8, § 1^erof the Act of 15 January 1990 referred to above, if he considers it necessary to provide adequate care to the person concerned.
The doctor who accessed the data bank under these conditions:
- in fact the reasoned statement in the patient's file referred to in section 9 of the Patient Rights Act of 22 August 2002;
- notify the accompanying committee and the provincial council of the College of Physicians of which it depends.
§ 8. In the event of a serious public health risk associated with an implantable medical device, or where there is a risk that such a device has resulted or may result in the death or serious deterioration of the health status of a patient, user or third party, and that the only reasonable way to remedy this situation requires the identification of one or more persons concerned, the AFMPS may proceed with the identification of the person concerned.
The AFMPS, in this case, makes a statement motivated by the National Council of the Order of Physicians.
The Council may delegate a doctor to monitor the identification.
Only a doctor may contact the person concerned and communicate the information required in accordance with the medical confidentiality.
The King determines, by a deliberate decree in the Council of Ministers, and after the advice of the Commission on the Protection of Privacy, the modalities by which such identification may take place, the means of communication that may be used on this occasion, and the processes that, in the light of the situation and the possible urgency, are pre-implemented to remedy the situation without carrying out such identification.
§ 9. Any other communication of personal data referred to in § 4 which is contained in the data bank, not covered by this article or its enforcement orders, requires prior authorization from the Sectoral Committee on Social Security and Health.
§ 10. A security logging is maintained for 30 years for each access to the data bank. This allows to identify persons who have accessed the data referred to in § 4, when, and what particular data.
§ 11. By derogation from § 1^er, the King may, by order deliberately in the Council of Ministers, and after the advice of the Commission on the Protection of Privacy, determine the cases in which the information referred to in § 4 is communicated by the provider of care to INAMI in place of the AFMPS, as well as the modalities of this communication and the rules of collaboration between INAMI and AFMPS in order to allow the fulfilment by the AFMPS of the tasks entrusted to him by the present article.
§ 12. The King may, by order deliberately in the Council of Ministers, and after the advice of the Commission on the Protection of Privacy specify the modalities for the conservation, security, consultation, communication and destruction of the data referred to in § 4.
§ 13. The King may, in order to protect public health, by a deliberate decree in the Council of Ministers, and after notice of the commission created or designated by him pursuant to article 9, § 4, of the Act of March 25, 1964 on drugs, extend the application of this article to other medical devices than implantable medical devices, on the basis of the risk that they may represent for public health and patients.
When the King applies the faculty provided for in the preceding paragraph, he may adapt the terms provided for under this article to the nature of medical devices, by order deliberately in the Council of Ministers, and after the advice of the Privacy Commission.
§ 14. In order to protect public health, the King may establish, by order deliberately in the Council of Ministers, and after notice of the commission created or designated by him pursuant to Article 9, § 4, the Act of March 25, 1964 on drugs and the Commission on the Protection of Privacy, the modalities of traceability of the medical devices which he determines, in accordance with the purposes described in § 3, and on the basis of the public health risks that these devices represent. If these are implantable medical devices subject to the communication obligation referred to in § 1^er, this paragraph refers to the life of the pre-implantation medical device. It determines in this context the information provided by distributors, professional practitioners and end-users, 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 accordance with the purposes referred to in § 3.
Art. 52. The King may, without prejudice to the provisions made on the basis of the Act of March 25, 1964 on medicines, subject the issuance of implantable medical devices by a pharmaceutical outlaw open to the public or a hospital outlaw to end-users to a withdrawal declaration on behalf of the patient written by the end-user.
In this case, the King establishes the model of this withdrawal declaration, as well as the terms and conditions.
Art. 53. When using a medical device implantable by a professional practitioner, the practitioner shall provide the patient with information on the device that is implanted. This information is delivered by the professional practitioner on a medium such as the patient can keep it and consult it on a permanent basis.
On the proposal of the Minister who has the Public Health in his or her powers, the King shall determine the terms and conditions for that information.
Art. 54. Physicians or dental practitioners who provide care services to patients with implantable medical devices are allowed to hold a deposit of medical devices and corresponding medications as referred to in Article 4, § 4, of Royal Decree No. 78 of 10 November 1967 relating to the exercise of health care professions.
The King may determine the terms and conditions of the authorization referred to in paragraph 1 and limit the authorization to the drugs necessary for the benefit referred to in paragraph 1.
Art. 55. In section 4 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions, last amended by the Act of 22 December 2008, the following amendments are made:
1° § 3, 1°, paragraph 9, is supplemented by the following sentence:
"Because of public health, we must hear, among other things:
1° the sale of medicines and medical devices that have not been obtained in accordance with the legal provisions;
2° the issuance of medicines and medical devices without taking into account the legal provisions on traceability. ";
2° § 4 is replaced by the following:
§ 4. The doctor or dental practitioner authorized to hold a repository supplies medicines and implantable medical devices either in a public-opened pharmaceutical outlaw or in a hospital outlaw. It can only deliver these implantable medicines and medical devices as part of a medical act.
For the purposes of § 2ter, the doctor referred to in paragraph 1^er concludes an agreement with an informal open to the public or a hospital informal.
For the purposes of this Act, the deposit is assimilated to an unopened informal to the public. If the agreement referred to in paragraph 2 is entered into with a holder of a hospital officin, the deposit is, for the purposes of this Act, also considered to be a hospital officin.
If the holder referred to in paragraph 3 does not assume the responsibility for the pharmaceutical offence, a pharmacist-title is designated by the holder to assume responsibility for the pharmaceutical offence.
The holder who is responsible for the pharmaceutical offence is responsible for the administrative formalities required under the registration procedure referred to in paragraph 2ter, last paragraph.
The King may determine the terms and conditions for the supply, management and control of such deposits that are separated from the medical office or other places where the doctor receives and examines patients, gives them advice or administers care. "
Art. 56. Article 6 of the Act of 25 March 1964 on drugs, last amended by the Act of 20 June 2013, is supplemented by a § 3, which reads as follows:
§ 3. The hospital pharmacist may, in the same way as other pharmacists, issue medicines and medical devices for the benefit of physicians authorized to hold a deposit."
Art. 57. The King sets the effective date of each of the articles of this chapter.
Article 53 comes into force for the devices that the King determines on the date the King determines.
Promulgate this Act, order that it be put on the State Seal and published by the Belgian Monitor.
Given in Brussels on 15 December 2013.
PHILIPPE
By the King:
Minister of Social Affairs and Public Health,
in charge of Beliris and Federal Cultural Institutions,
Ms. L. ONKELINX
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
____
Note
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 and transmitted to the Senate, No. 53/3057/5.
Full report: 7 November 2013.