Decision of 5 July 1993, laying down rules on the marketing of active implants
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of the Secretary of State for Welfare, Public Health and Culture of 28 October 1992, after publication of the draft of this Decision in the Official Gazette of 16 August 1991, No 158;
Having regard to Directive 90 /385/EEC of the Council of the European Communities of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( PbEG L 189) and on Article 3, first paragraph, point A and f. , of the Law on Medical Devices and the Articles 1 , third member, and 26, point f. , of the Act on the Medicinal Product ;
Having regard to the opinion of the Medicinal Products Committee (opinion of 26 August 1991, Geco 4560),
The Council of State heard (opinion of 29 December 1992, No W13.93.0512);
Having regard to the further report of the Secretary of State for Welfare, Health and Culture of 15 June 1993, GMV/G 931357,
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. active medical device : a medical device including the accessories and software necessary for its proper functioning, which depends on an electric energy source for that operation, or any other than directly by the human body or gravity Energy source generated;
b. active implant : An active medical device designed to be implanted, fully or partially, in an operative or medical way in the human body or by a medical procedure in a natural opening, and intended to be used after that procedure remain the body;
c. Custom made active implant : an active implant specially manufactured according to written prescription from a medical specialist, in which under his responsibility the specific characteristics of the design are indicated, and is intended to be exclusively produced by a certain patient needs to be used; implants manufactured according to method of continuous manufacture or of series manufacturing, requiring adaptation to meet the specific needs of the physician or of another professional user, are not covered here;
ed. Active implant for clinical trial : an active implant which is intended to be placed at the disposal of a medical specialist in order to carry out clinical investigations as provided for in point 2.1 of Annex 7 to the Directive in an appropriate clinical human environment;
e. destination : the use to which the device is intended according to the instructions given by the manufacturer on the label, in the instructions for use or in the promotional material;
f. Directive : Directive 90 /385/EEC of the Council of the European Communities of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( PbEG L 189);
g. Manufacturer: the person, including legal person, or his authorised representative established within the territory of a Member State, who:
1 °. is responsible for the design, manufacture, packaging or labelling of an active implant for placing on the market under its own name, whether or not these operations are carried out by the same person. or under his responsibility by a third party; or
2. one or more prefabricated products assembles, packages, treats, innovates or labels, or confers on such products an active implant destination for the purpose of placing them on the market under their own name;
(h) placing on the market: for the first time against payment, free of charge, of an active implant, which is not intended for clinical examination, for the purpose of distribution or use in the market of a Member State, whether or not it is intended to be used for the purpose of distributing or providing for the purpose of conducting a clinical trial; is going to have a new or a renewed active implant;
i. CE marking : the marking in accordance with the model set out in Annex 9 to the Directive;
j. notified body : the authority designated for the implementation of Article 11 of the Directive.
(k) Member State shall mean the State, which is a member of the European Union, as well as the State Party to the Agreement on the European Economic Area;
l. law: the Law on medical devices ;
m. Delegate : the natural or legal person established in a Member State, which is expressly designated by the manufacturer as such, acting on behalf of the manufacturer and which may be legal in a Member State by the authorities and authorities in a Member State addressed in respect of the obligations of the manufacturer under the Directive;
n. clinical data : information on safety or performance resulting from the use of a device, derived from:
-clinical examination of the device concerned, or
-clinical examination of, or other studies on, a similar device for which equivalence to the device in question can be demonstrated, described in the scientific literature, or
-published or unpublished reports on other clinical experience of the device in question or with a similar device whose equivalence may be demonstrated with the device in question.
2 Under a manufacturer, it is not understood to include a person who, other than a manufacturer of an active implant within the meaning of the first member, is G , 1 °, active implants that have already been placed on the market, assembles for an individual patient, or adjusts according to their intended purpose.
3 An amendment to Annexes 2, 3, 4, 5, 6 or 7 to the Directive shall apply to the application of this Decision as from the day on which the amendment in question must be implemented.
2 It is a person, including legal person, other than the manufacturer, who is prohibited from holding or delivering an active implant if the active implant is not satisfied with the active implant. Articles 10 and 11 .
1 An active implant complies with the requirements set out in Annex 1 to the Directive, taking into account the intended use of the active implant.
2 Our Minister, in implementation of the Directive, shall designate standards for compliance with which active implants are suspected of complying with the requirements referred to in paragraph 1.
1 An active implant is equipped with the CE marking.
2 An active implant shall be provided with the CE marking only if it meets the requirements set out in Annex 1 to the Directive.
3 By way of derogation from the first paragraph, custom-made active implants and active implants intended for clinical examination shall not bear the CE marking.
4 The CE marking shall be accompanied by the identification number of the notified body which has carried out the procedures referred to in Annexes 2, 4 and 5 to the Directive or procedures adopted by another Member State of the European Union.
5 The CE marking and the identification number referred to in paragraph 4 shall be affixed visibly, legibly and indelibly to the packaging that ensures sterility, on the packaging in which the active implant is traded, and on the packaging instructions for use.
6 An active implant is not labelled or inscription which could create confusion as to the meaning or the graphic design of the CE marking; if other markings are on the packaging and on the instructions for use of the device shall not reduce the visibility and legibility of the CE marking;
1 For the assessment or an active implant to the in Article 3, first paragraph The manufacturer shall, in the context of the tasks for which it has been notified, follow one of the following procedures, in accordance with the requirements set out in the said requirements:
(a) the procedure relating to the EC declaration of conformity set out in Annex 2 to the Directive,
(b) the procedure for EC-type examination, as defined in Annex 3 to the Directive, in combination with
1 °. either the EC verification procedure set out in Annex 4 to the Directive,
2 °. either the procedure of the EC declaration of conformity with the type described in Annex 5 to the Directive.
2 During the conformity assessment procedure, the notified body shall take into account the available results of assessment and verification activities which may be carried out in accordance with the provisions of this Decision at an intermediate stage of the assessment of conformity assessment procedures. manufacturing took place.
3 The manufacturer shall be obliged to provide the notified body with any information which may reasonably be required for the performance of its task in respect of this Decision.
4 A decision taken in accordance with Annex 2, 3 or 5 of the Directive shall lapse after a period of not more than five years to be determined by the notified body. At the request of the manufacturer, the notified body may extend this period by five years with periods of a period of five years.
5 By way of derogation from paragraph 1, the Minister may, in implementation of Article 21, paragraph 3, and subject to the procedure laid down in Article 7 (2) of the Directive, provide that a single type of active implant may be used as a the procedures referred to in the first paragraph must be followed.
6 A decision taken pursuant to paragraph 5 shall be published in the Official Gazette . In addition, please specify the number of the Official Journal of the European Communities In which, where appropriate, the relevant elements of the measures taken by the Commission of the European Communities have been published.
7 In implementation of Article 11 of the Directive, our Minister may designate one or more bodies to carry out the procedures referred to in paragraph 1, but only if those bodies comply with the criteria set out in Annex 8 to the Directive. In each case, the specific tasks of the authority shall be indicated in such a manner.
8 Our Minister shall withdraw the designation of an authority if that authority does not comply with the criteria referred to in paragraph 2 or the regulation referred to in paragraph 3.
9 The Secretary of State shall designate standards for the implementation of the Directive when a body is presumed to comply with the criteria referred to in paragraph 2.
10 With the entry into force of the first paragraph, A and B The procedures referred to shall be treated in the same way as the competent authorities of the other Member States of the European Communities in the framework of the Directive.
The manufacturer who has a registered office in the Netherlands and who places active implants on the market under his own name, in accordance with the procedure referred to in Article 9, second paragraph, of the Directive, shall report to a person designated by Our Minister. the address of the registered office and the description of the active implants concerned.
2 The manufacturer who, in a Member State other than the Netherlands, has its registered office and who places active implants on the market under his own name, in accordance with the procedure referred to in Article 9, second paragraph, of the Directive, shall report to the the competent authorities of that Member State shall address the registered office and the description of the active implants concerned.
3 The manufacturer who does not have a registered office in a Member State and who places active implants on the market under his own name shall designate a single authorised representative in the European Union.
1 A tailor-made active implant shall be accompanied by a declaration from the manufacturer, containing the information set out in Annex 6, point 2.1, of the Directive.
2 By way of derogation from Article 3, first paragraph , there is no need for a custom-made active implant to satisfy the requirements of Annex 1 to the Directive, provided that in respect of the requirements which are not met, the reasons for which the declaration referred to in paragraph 1 of the first paragraph expressly is included.
3 The manufacturer of a custom-made active implant shall keep the data referred to in Annex 6, point 3.1, of the Directive at the disposal of an administrative authority designated by Our Minister for that purpose.
1 For devices intended for clinical examination, the manufacturer shall, before the start of the study, inform the State Supervision of the Public Health and follow the procedure set out in Annex 6 to the Directive.
2 For the notification, the following information shall be provided:
-the name and address of the manufacturer,
-the information enabling the relevant active implant to be identified,
-the name of the doctor, as well as the institution responsible for carrying out the investigation,
-the extent of the examination and number of the active implants concerned;
-the site, the beginning and the likely duration of the investigation.
3 By way of derogation from Article 3, first paragraph , an active implantate for clinical examination at the point of the study need not comply with the requirements set out in Annex 1 to the Directive.
4 The manufacturer shall apply the active implantation to clinical trials only if:
-one on the basis of Article 16 of the Law Medical Scientific Research with People a positive opinion on the research programme, including the clinical research plan, has been issued by the Commission approved by the Commission; and
-prior to the time at which the clinical trial begins to have an insurance cover covering his liability for damage caused by the clinical investigation.
The clinical examination shall be carried out in accordance with Annex 7 to the Directive.
6 The manufacturer shall keep the following information available to the State Supervision on Public Health:
-at least for five years after the beginning of the examination, the data referred to in Annex 6, points 2.2 and 3.2 of the Directive; and
-the report provided for in Annex 7, point 2.3.7 of the Directive.
7 Article 4, third paragraph, and the first and fourth members -the sixth paragraph, first indent, of this Article shall not apply where medical devices are used in clinical trials to be carried out in accordance with Article 4 provided the CE marking, provided that the purpose of this examination is the same intended use of the medical devices as the corresponding conformity assessment procedures.
8 The manufacturer shall inform the State Supervision of Public Health of the termination of the clinical examination, indicating the reasons for the early termination. The manufacturer shall keep the report referred to in point 2.3.7 of Annex 7 to the State Supervision of Public Health.
For the purposes of implementing the Directive, our Minister shall designate standards for the fulfilment of the presumption of compliance with the provisions of Annex 7 to the Directive relating to clinical evaluation.
The Articles 3 and 4 Do not apply to active implants presented at fairs, exhibitions, demonstrations and similar occasions, provided that on a visible sign it is clearly indicated that the active implant is not on the inside. Annex 1 of the Directive shall comply with the requirements laid down in Annex 1 to this Directive and may not be applied before it has been brought into conformity by the manufacturer.
An active implant is being implanted by the Article 2, second paragraph , the person referred to was not delivered:
a. if that plea does not apply to the Article 3, first paragraph , complies with the said requirements;
(b) after the expiry of the deadline for safe implantation as provided for in point 14 of Annex 1 to the Directive.
The Article 2, second paragraph The person referred to above shall ensure that the active implants which he holds are kept in a proper, meaning and orderly manner and in compliance with the storage data referred to in Annex 1, point 14.2.
1 This Decision shall enter into force from the day following the date of issue of the State Sheet in which it is placed, except that until 1 January 1995 the placing on the market and the application of active implants complying with the application or control of the product concerned shall continue to be applied Law on medical devices rules laid down on 31 December 1992.
2 By way of derogation from Article 2, first paragraph ), the manufacturer is authorised until 14 June 1998 to have active implants available or to be delivered if the requirements laid down by or pursuant to the Act as applicable to those funds are met on 31 December 1994.
3 By way of derogation from Article 2, second paragraph , the person referred to in that paragraph shall be allowed to have, or to supply, the hands of the active implants delivered in accordance with paragraph 1, if they have been complied with, with regard to such means, to the competent authorities of the Member State or to the rules as they applied at 31 December 1994.
4 By way of derogation from Article 2 (3) , it is permitted to apply active implants delivered prior to 1 January 1995 or delivered in accordance with the first or second paragraphs.
This decision is cited as: 'Active implants' Decision.
Burden and order that this Decision, together with the accompanying note of explanatory note to the State Sheet will be placed.
' s-Gravenhage, 5 July 1993
The Secretary of State for Welfare, Health and Culture,
H. J. SimonsIssued the 22nd of July 1993
The Minister of Justice,
E. M. H. Hirsch Ballin