Key Benefits:
Decision of 30 March 1995 laying down rules on the placing on the market and use of medical devices and amending certain general measures of management
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of Our Minister for Health, Welfare and Sport of 28 September 1994, GMV/G 943101,
Having regard to
Having regard to the opinion of the Medicinal Products Committee (opinion opinion of 21 January 1994, Geco 4802 /EJ),
The Council of State heard (opinion delivered on 21 December 1994, No W13.94.0604);
Having regard to the further report by Our Minister for Health, Welfare and Sport of 20 March 1995, GMV/G 95767.
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. Custom medical device: a medical device specially designed according to the prescription of a doctor or other person empowered to do so by virtue of his or her profession, in which, under his responsibility, the specific medical device is the characteristics of the design are indicated, and this is intended to be used exclusively by a particular patient;
b. Medical device intended for clinical examination: a medical device intended for use in a clinical trial as referred to in Annex X, Part 2, to the Directive;
c. Aid: a product specially designed by the manufacturer to be used with a medical device so that it can be used or applied in accordance with its intended purpose;
ed. Manufacturer: the person, including legal person, or his authorised representative, who:
1 °. is responsible for the design, manufacture, packaging and labelling of a medical device for placing on the market under its own name, regardless of whether these operations are carried out by that person or under his responsibility by a third party; or
2 °, which assembles, packages, treats, refreshes or labels one or more prefabricated products or grants them the purpose of a medical device for the purpose of placing them on their market under their own name;
e. Delegate: the person established in a Member State, including legal person established in a Member State, who, after having been expressly appointed by the manufacturer, may be addressed in legal proceedings in respect of the obligations imposed by or pursuant to this Decision. manufacturer have been imposed;
(f) placing on the market: for the first time against payment or free of charge a medical device, which is not intended for clinical examination, for the purpose of distribution or use on the market of a Member State, whether or not it is intended to be used for the purpose of conducting a medicinal product; is a new medical device or a new medical device;
g. destination means the use to which the medical device is intended according to the instructions given by the manufacturer on the label, in the instructions for use or in the advertising material;
h. Notified body: the authority designated for the implementation of Article 16 of the Directive;
(i) Member State: the State, which is a Member of the European Union, as well as the State Party to the Agreement on the European Economic Area;
j. Directive: Directive No 93 /42/EEC of the Council of the European Communities of 14 June 1993 concerning medical devices ( PbEG L 169);
k. law: the Law on medical devices ;
l. 'CE' marking: the marking in accordance with the specimen in Annex XII to the Directive;
m. human blood derivative: a substance incorporated as an integral part in a medical device, which, if used alone, may be considered as a component of a medicinal product or as a blood product as intended in Article 1, first paragraph, point (d) of the Pharmaceutical Act , and which can support the functioning of the device on the human body;
n. auxiliary sub-category means a group of devices intended for use in the same fields, or in common technology;
o. generic auxiliary group: a group of tools intended for the same or similar use, or a common technology, so that they can be classified in a generic way, involving outside specific properties consider;
p. Single-use device: a device intended to be used only once for one patient;
q. Directive 2003 /32/EC: Commission Directive 2003 /32/EC of 23 April 2003 laying down detailed specifications for the requirements laid down in Council Directive 93 /42/EEC as regards medical devices manufactured with the use of tissue of animal origin (PbEU L 105);
r. clinical data: information arising from the use of a device concerning safety or performance 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 Medical devices manufactured according to the methods of continuous manufacture or of seriefabrikage and requiring an adjustment to meet the specific needs of the physician or of another professional user will not be considered a custom-made medical device.
3 Under a manufacturer, it is not understood a person who assembles medical devices already placed on the market in the sense of the first member of the first paragraph, other than a manufacturer of a medical device, assembles for a medical device. Individual patient, or adjudation according to their intended use.
4 An amendment to Annex I, II, III, IV, V, VI, VII, VIII, IX or X of the Directive, or of the Annex to Directive 2003 /32/EC, shall apply to the application of this Decision from the date of implementation of the amendment in question. have been given.
This Decision shall also apply to the ancillary system and to the software required for the proper functioning of the medical device.
1 This Decision shall not apply to:
a. In-vitro diagnostics to which the In Vitro Diagnostics is applicable.
b. Active implants in the sense of the Active Implants Decision ;
c. Medical devices intended for the administration of a medicinal product as specified in Article 1, first paragraph, point (b) of the Pharmaceutical Act , in so far as they are placed on the market in such a way that:
1 °. the medical device and the medicinal product form an indivisible whole,
2 °. they are intended solely for use in the given combination; and
3 °. cannot be re-used;
d. human blood, products of human blood, blood plasma or blood cells of human origin or on medical devices which at the time they are placed on the market such blood products, blood plasma or similar blood cells, excluding derivatives of human blood;
e. transplants, tissues or cells of human origin, or products containing or derived from tissues or cells of human origin;
f. transplants, tissues or cells of animal origin, unless the appropriate medical device is made using animal tissue that is not made viable or of non-viable products derived from Of animal tissue;
g. personal protective equipment within the meaning of the Personal protective equipment department decision .
2 However, the essential requirements set out in Annex I to the Directive, in so far as they relate to safety and performance aspects, shall apply to the medical devices referred to in subparagraph (c) of the first paragraph.
1 The manufacturer shall be prohibited from holding or delivering a medical device if the device is not met by the manufacturer. Articles 5 to 9c , 12 and 13 .
2 It is the person, including legal person, other than the manufacturer, who joins medical devices to deliver them in the form of a system or a treatment package, are prohibited from holding a system or a treatment package. to deliver or deliver if related to the system or treatment package is not met Article 10 .
3 A person other than the person referred to in paragraph 2, other than the manufacturer, shall be prohibited from holding or supplying a medical device if the medical device is not satisfied with the medical device, if the medical device is not satisfied with the medical device. Articles 15 and 16 .
4 It is prohibited to apply a medical device if the medical device does not comply with the requirements of this Directive. Articles 5 to 10 , 12 , 13 , 15 and 16 was delivered.
1 The Netherlands-based manufacturer who is under his own name and in accordance with the in Article 9 (5) If the conformity assessment procedure provides for a medical device, shall inform the public authority designated by our Minister before the delivery takes place:
a. his place of residence within the meaning of Article 10, Book 1 of the Civil Code ; and
b. a description of the relevant medical device; and, as soon as possible,
c. modifications of these data, as well as the termination of the activity.
2 The first paragraph shall apply mutatis mutandis to the Article 10 The person referred to in the Article 12 Intended manufacturer.
3 The manufacturer established outside a Member State shall designate an authorised representative.
1 A medical device must comply with the requirements of Annex I to the Directive, taking into account the intended use of the medical device concerned.
2 The information to be provided to the user and the patient as referred to in point 13 of Annex I to the Directive are drawn up in the Dutch language.
3 Our Minister shall designate, for the purposes of Article 5 of the Directive, or, where appropriate, monographs of the European Pharmacopoeia in respect of the compliance with which medical devices are suspected of complying with the provisions of the first paragraph of Article 5 of the Directive. requirements.
4 The references of the designated standards and monographs are published in the Official Gazette announced.
1 A medical device shall be marked with the CE marking.
2 A medical device shall bear the CE marking only if it complies with the requirements set out in Annex I to the Directive.
3 The CE marking shall not be affixed to a product which is not a medical device.
4 By way of derogation from the first paragraph, medical devices and medical devices made for use in clinical trials shall not be marked with CE marking.
5 The CE marking shall be accompanied by the identification number of the notified body which has carried out the procedures referred to in Annexes II, IV, V and VI to the Directive or of the notified body which has been notified by another Member State of the procedures have been performed.
6 The CE marking and the identification number referred to in paragraph 5 shall be affixed visibly and indelibly to the medical device or to the packaging which ensures sterility, and to the instructions for use.
7 In case of technical reasons it is not possible to affmark CE marking on the medical device or on the packaging which guarantees sterility, the marking shall be on the packaging in which the medical device is placed on the market. shall be brought.
8 A medical device is not marked with a marking or marking which could create confusion as to the meaning or the graphic design of the CE marking; if the medical device, the packaging or the instructions for use are on the medical device Other markings shall not reduce the visibility and legibility of the CE marking.
1 Medical devices are to be classified by the manufacturer in Class I, IIa, IIb or III as set out in Annex IX to the Directive.
2 By way of derogation from the first paragraph, breast implants and hip, knee and shoulder replacements shall be classified by the manufacturer in Class III.
3 To a decision of the notified body taken pursuant to the classification rules, the manufacturer may appeal to our Minister.
1 This Article shall not apply to a tailor-made medical device or medical device intended for clinical examination.
2 For the assessment of a medical device classified in class III, to the in Article 6, first paragraph The manufacturer shall, with a view to affixing the CE marking, follow one of the following procedures, in order to comply with the said requirements:
(a) the procedure relating to the EC declaration of conformity set out in Annex II to the Directive; or
(b) the procedure for EC-type examination as set out in Annex III to the Directive, in combination with:
1 °. either the EC-label procedure set out in Annex IV to the Directive;
2 °. either the procedure of the EC declaration on production quality assurance set out in Annex V to the Directive.
3 For the assessment or a class II B Classified medical device to the in Article 6, first paragraph The manufacturer shall, with a view to affixing the CE marking, fulfil one of the following procedures, in order to comply with the said requirements:
(a) the procedure relating to the EC declaration of conformity set out in Annex II to the Directive, with the exception of the procedure described in point 4 of that subparagraph; or
(b) the procedure for EC-type examination as defined in Annex III to the Directive in combination with
1 °. either the EC-label procedure set out in Annex IV to the Directive;
2 °. either the procedure of the EC declaration on production quality assurance set out in Annex V to the Directive;
3 °. either the product quality assurance procedure set out in Annex VI to the Directive.
4 For the assessment or one in Class II A Classified medical device to the in Article 6, first paragraph The manufacturer shall, with a view to affixing the CE marking, fulfil one of the following procedures, in order to comply with the said requirements:
(a) the procedure relating to the EC declaration of conformity set out in Annex II to the Directive, with the exception of the procedure described in point 4 of that subparagraph, or:
(b) the procedure relating to the EC declaration of conformity set out in Annex VII to the Directive, in combination with:
1 °. either the EC-label procedure set out in Annex IV to the Directive;
2 °. either the procedure of the EC declaration on production quality assurance set out in Annex V to the Directive;
3 °. either the product quality assurance procedure set out in Annex VI to the Directive.
5 For the assessment of a medical device classified in Class I, to the in Article 6, first paragraph The manufacturer shall, with a view to affixing the CE marking, before placing on the market of the medical device the EC declaration of conformity, as set out in Annex VII to the Directive, shall, in order to apply the CE marking, take the relevant requirements, and shall take the relevant information to the effect that the requirements of the Annex to the Annex to this Regulation.
6 In the case of a conformity assessment procedure the intervention of a notified body preconditions, the manufacturer shall refer to a notified body of his choice in the context of the tasks for which that body is notified.
7 During the conformity assessment procedure, the manufacturer or the notified body shall take into account the available results of assessment and verification activities which may be carried out in accordance with this Decision at an intermediate stage of manufacture. have taken place. Account shall also be taken of the results of assessment and verification activities which have taken place in accordance with or under the conditions of Law rules laid down on 31 December 1994.
8 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.
For medical devices classified in Class III, as intended Article 9a, first paragraph , the manufacturer shall provide the notified body with all relevant information that it needs to carry out an assessment of its current risk analysis and risk management strategy. Any new information on the risk of transmissible spongiform encephalopathies, collected by the manufacturer and relevant to the devices manufactured by it, shall be sent to the notified body for information.
Amendments related to the procedures for the selection, collection, treatment and inactivation or elimination which may affect the risk management result of the manufacturer, shall be submitted for additional purposes prior to its implementation. submitted approval to the notified body.
9 A decision taken in accordance with Annex II or III 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.
10 The procedures referred to in the second paragraph up to the fifth paragraph shall be treated in the same way as the competent authorities of the other Member States for the purposes of the Directive.
1 Before an application for a conformity assessment in accordance with Article 9, second paragraph , to be submitted, the manufacturer shall provide a medical device to which this decision based on the Article 3, first paragraph, point (f) , where the aid is manufactured using animal tissue from bovine, ovine, caprine, deer, elk, mink or cat or by means of derived products of such tissue, the the procedure for risk analysis and risk management laid down in Annex, Part 1, of Directive 2003 /32/EC.
The first paragraph shall not apply to medical devices which are not intended to come into contact with the human body or which are intended solely to come into contact with the skin of the skin.
1 Within the framework of the conformity procedures referred to in Article 9, second paragraph In the case of medical devices referred to in Article 9a, first paragraph, the notified body concerned shall verify that the medical devices comply with the essential requirements set out in Annex I to the Directive and the Annex, Section 1 of Directive 2003 /32/EC.
2 The notified body shall assess the risk analysis and risk management strategy pursued by the manufacturer, and in particular:
a. Information provided by the manufacturer;
b. the justification for the use of animal tissue or products derived therefthereof;
c. the results of studies on elimination or inactivation, or of literature review;
d. The supervision by the manufacturer of the origin of the raw materials, on the final products and on the subcontractors;
e. the need to control the provenance, including deliveries by third parties.
3 The notified body shall take into account, in the assessment of risk analysis and risk management under the conformity assessment procedure for the source material, a TSE approval certificate of the European Directorate for the medicinal product quality, hereinafter referred to as the 'TSE-certificate', where available.
4 Except for medical devices manufactured using source material for which the TSE approval certificate referred to in paragraph 3 has been issued, the notified body shall, through the intervention of Our Minister, request that the advice from the competent authorities of the other Member States on their assessment of and their conclusions on risk analysis and risk management by the manufacturer of the tissues and derived products intended to be used in the medical device are used.
5 Before issuing an EC examination certificate for the draft or an EC-type examination certificate, the notified body shall take due account of the observations which it has submitted within 12 weeks of the opinion of the national authorities has received a request.
For medical devices as intended Article 9a, first paragraph With regard to which an EC research certificate for the design or declaration of EC type-examination was issued before 1 April 2004, an additional EC examination certificate for the design or additional declaration of EC type-examination shall be provided for: obtained from compliance with the specifications set out in the Annex, part 1, to Directive 2003 /32/EC.
For the application of Article 3, first paragraph, point (f) , Article 9a, first paragraph , Article 9b , Article 9c The following definitions apply:
a. cell: the smallest structural unit of an organism which is capable of being independent and capable of replacing itself in a suitable environment;
b. Tissue: a complex of cells or extracellular constituents:
c. derived product: material obtained from animal tissue by means of a manufacturing process, such as collagen, gelatin, monoclonal antibodies,
ed. non-viable: without possibility of metabolism or multiplication;
e. Transferable agents: non-classified pathogenic entities, prions and entities, such as the agents of bovine spongiform encephalopathies and of scrapie;
f. reduction, elimination or removal: a process of reducing, eliminating or removing the number of communicable agents in order to prevent contamination or a pathogenic reaction;
g: inactivation: a process which reduces the ability of transferable agents to cause infection or a pathogenic reaction;
h. country of origin: the country where the animal was born, reared or slaughtered;
i. Starting material: the raw material or any other product of animal origin from which or by means of which the Article 9a, first paragraph , the tools referred to are produced.
1 The person, including legal person, who combines medical devices with the CE marking, in accordance with their intended purpose and within the limits specified by the manufacturers, with the intention of delivering them in the form of A system or a treatment package shall draw up a declaration stating:
a. that he has verified the mutual compatibility of the medical devices in accordance with the instructions of the manufacturers, and that he carried out the amalgamation in accordance with those instructions; and
b. that he has packaged the system or treatment package and has provided relevant information to users, including the relevant instructions of the manufacturers; and
c. that all such work is subject to appropriate methods of internal control and control.
2 Where medical devices are pooled in respect of which the conditions referred to in paragraph 1 are not fulfilled, the system or treatment package shall be treated as a medical device in itself and as such shall be treated as such subject to the relevant procedure of Article 9 .
3 The person, including legal person, with a view to their delivery:
a. Systems,
b. Treatment packages; or
c. any other medical device bearing the CE marking, which must be sterilized prior to use in accordance with the manufacturer's instructions, shall follow one of the procedures set out in Annex II or V of the Directive to the extent that this relates to the acquisition of sterility. The person shall make a declaration that the sterilisation has been carried out in accordance with the manufacturer's instructions.
4 The funds referred to in paragraphs 1 and 3 shall not be subject to an additional CE marking.
5 The systems and treatment packages shall be accompanied by the information set out in Annex I to the Directive. This information, if necessary, contains the information provided by the manufacturers of the devices to be joined together.
6 The person, including legal person, shall keep the certificate referred to in paragraphs 1 and 3 above for a period of five years from the date of aggregation or sterilisation.
1 In implementation of Article 16 of the Directive, our Minister may designate one or more authorities to Article 9 carry out the procedures referred to, but only if those bodies comply with the criteria set out in Annex XI to the Directive. In each case, the specific tasks of the authority shall be indicated in such a manner.
2 Our Minister shall designate standards for the implementation of the Directive, when a body is presumed to comply with the criteria referred to in paragraph 1.
3 When the body finds that the manufacturer has not complied with or no longer fulfils the applicable requirements of this Decision, or if no statement of information may have been issued, it shall, taking into account the requirements of the Principle of proportionality, the suspension, withdrawal or restriction of the declaration issued, unless the manufacturer ensures that the above mentioned requirements are satisfied by introducing a suitable corrective measure. In the event of suspension, revocation or limitation of the declaration, or if intervention of the Article 5, first paragraph If necessary, the public authority shall inform the public authority thereof.
4 The authority shall, on request, inform the Article 5, first paragraph the public authority and the other notified bodies shall be informed of the certificates issued or refused and, on request, shall make available all relevant information.
5 In implementation of Article 16 of the Directive, our Minister may attach to the designation rules.
6 Our Minister shall withdraw the designation if the body does not comply with the rules laid down by the Minister under paragraph 3, third and fourth, or under the fifth paragraph by the Minister.
1 The manufacturer of a custom-made medical device shall, before delivering the product, produce a declaration containing the particulars referred to in point 2.1 of Annex VIII, and shall follow the procedure referred to in that section.
2 A custom-made medical device, classified in Class III, IIb or IIa, must be accompanied by the statement referred to in paragraph 1, which becomes available to the patient identified by a name, acronym or number code. ed.
3 By way of derogation from Article 6, first paragraph , there is no need for a medicated medical device to satisfy the requirements of Annex I to the Directive, provided that in respect of the requirements which are not met, the reason for the declaration referred to in the first paragraph It is explicitly included.
4 The manufacturer of a custom-made medical device shall keep the data referred to in point 3.1 of Annex VIII of the Directive at the disposal of an administrative authority designated by Our Minister for that purpose.
1 For medical devices intended for clinical examination, the manufacturer shall inform the State Supervision of the Public Health by means of the declaration provided for in Annex VIII to this Regulation before the start of the study. The Directive and the procedure laid down in Annex VIII to the Directive shall be followed.
2 By way of derogation from Article 6, first paragraph , a medical device intended for clinical examination at the point of study shall not be required to comply with the requirements set out in Annex I to the Directive.
3 The manufacturer shall supply the medical device intended for clinical examination only if:
a. 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;
(b) prior to the time at which the clinical investigation begins to have an insurance cover covering his liability for damage caused by the clinical investigation.
The clinical examination is carried out in accordance with Annex X of the Directive.
5 The manufacturer shall inform the State Government on public health of the termination of the clinical examination, stating its reasons in the event of an early termination.
6 The manufacturer shall keep the following information available to the State Supervision on public health:
a. the information referred to in point 3.2 of Annex VIII to the Directive;
(b) the clinical examination report referred to in point 2.3.7 of Annex X to the Directive.
7 Article 7, fourth paragraph -the first and fourth paragraphs, and the sixth paragraph (a) of this Article shall not apply where medical devices are used in the clinical trials to be carried out in accordance with the conditions laid down in Annex II to this Regulation. Article 7 bear the CE marking, provided that the purpose of this examination is the same use of the medical devices as the corresponding conformity assessment procedures are intended to be used.
The Articles 6 and 7 shall not apply to medical devices presented at fairs, exhibitions, demonstrations and similar occasions, provided that a visible sign clearly indicates that the medical device is not in accordance with the requirements of the Annex I of the Directive shall be compliant and cannot be applied before it has been brought into conformity with those requirements by the manufacturer.
A medical device is provided by the Article 4, third paragraph , the person referred to was not delivered:
a. if that product is not the one in the Articles 6, first and second members , and 7, first paragraph , complies with the said requirements;
(b) after the expiry of the expiry date referred to in point (e) of Annex I to the Directive.
The Article 15 shall ensure that the medical devices available to him are kept in a proper, meaning, orderly and orderly manner and taking into account the conditions set out in point 13.3 (i) of Annex I to the Directive.
The application of a ripple filler that remains lifelong in the body is prohibited for any other than reconstructive purposes.
The following Decisions shall be repealed:
(a) the Decision of the Rubber Condoms;
b. The Decision Trade sterilized medical devices;
c. Decision electro-medical devices;
d. EEC-Ice-control thermometers.
1 By way of derogation from Article 4, first paragraph , the manufacturer may, until 14 June 1998, have access to or supply of medical devices if they have been complied with in respect of such means by the aid to or from the Law rules laid down on 31 December 1994.
2 By way of derogation from Article 4, second paragraph , the person referred to in that paragraph is allowed to have, or to supply, a system or treatment package consisting of the medical devices referred to in paragraph 1 if, in respect of such means, the aid is fulfilled or under the Law rules laid down on 31 December 1994.
3 By way of derogation from Article 4, third paragraph , the person referred to in that paragraph shall be allowed to have available or deliver the medical devices referred to in paragraph 1 by 30 June 2001 at the latest, if they have been complied with in respect of such means by the competent authorities of the Member States of the European Union, if they have been satisfied with or under the conditions of Law rules laid down on 31 December 1994.
4 By way of derogation from Article 4 (4) , it is permissible to apply medical devices delivered prior to 1 January 1995 or delivered in accordance with the first, second, or third paragraphs.
5 By way of derogation from Article 4 Have the holding, delivery and for the first time applying mercury-filling and maximum-body fever thermometers for measuring the body temperature of humans and animals up to 30 June 2004 if they have been manufactured according to a model according to Article 3 of the General EEC Treaty has been admitted before 1 January 1995 and the period of validity of the EEC pattern approval has not yet expired.
6 With regard to medical devices referred to in the preceding paragraphs, to which this Decision is not applied and to which the CE marking is affixed under one or more legal arrangements, the relevant medical devices shall be the subject of such medical devices; the documents, manuals or instructions for use shall be the subject of the Official Journal of the European Communities published references of the directives which are the basis of those legal arrangements.
This Decision shall enter into force from the day following the date of issue of the State Sheet where it is placed.
This decision is cited as: Decision medical devices.
Burden and order that this Decision, together with the accompanying note of explanatory note to the State Sheet will be placed.
' s-Gravenhage, 30 March 1995
Beatrix
The Minister for Health, Welfare and Sport,
E. Borst-Eilers
Published the eleventh may 1995The Minister of Justice,
W. Sorgdrager
