Key Benefits:
Decision of 22 June 2001 laying down rules on the placing on the market and use of medical devices for in vitro diagnostic tests (in vitro diagnostic documents)
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 26 October 2000, GMV/MH 2120408, after publication of the draft of this Decision in the Official Journal of 27 October 1999, No 207;
Having regard to
- Directive 98 /79/EC of the European Parliament and of the Council of 27 October 1998 concerning medical devices for in vitro diagnostic medical devices (PbEG L 331), Article 3, 1st paragraph, of the Law on Medical Devices ;
The Council of State heard (opinion of 16 March 2001, No. W13.00.0503/III);
Having regard to the further report of Our Minister of Health, Welfare and Sport of June 2001, GMV/L 2166009.
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. in vitro diagnostics: a medical device that is a reagent, a reactive product, a calibration material, a control material, a kit, a device, a device, a device, or a system used individually or in combination and is by the manufacturer for use in the in vitro study of specimens derived from the human body, including donor blood and tissue, solely or principally with the purpose of providing information:
-about a physiological or pathological condition, or
-about a congenital disorder, or
-to determine the safety and degree of compatibility with potential recipients, or
-to test the effects of therapeutic measures.
b. high-risk diagnostics : an in vitro diagnostic diagnostic system, intended solely or principally for:
-detecting, confirmatory and quantifying the presence in human specimens of markers of HIV infection, HTLV I and II, and hepatitis B, C and D;
-the determination of tumour-marker substances,
-the diagnosis of hereditary diseases,
-predictive genetic research.
c. control and calibration materials: a substance, material or article, designed by the manufacturer to establish a measurement relationship, or to check the performance characteristics of an in vitro diagnostic device in relation to the destination;
ed. Container for specimens: a medical device, whether or not the vacuum type, specially designed by the manufacturer to directly capture and store specimens from the human body for the purpose of in vitro diagnostic tests;
e. Auxiliary: a product which is not an in vitro diagnostic product but is specifically intended by the manufacturer to be used together with an in vitro diagnosis so that that in vitro diagnosis can be used in accordance with its intended use;
f. for self-testing for in vitro diagnostics: an in vitro diagnostic device intended for use by the manufacturer to be used in a home situation;
g. For performance evaluation intended in vitro diagnostics: an in vitro diagnostic device intended by the manufacturer to be tested on one or more times on its performance in medical laboratories or in any other suitable environment outside its own business premises;
h. new type in vitro diagnosis: A type of in vitro diagnosis:
-that, as regards the substance to be examined, or another parameter, is distinct from another type which has been continuously marketed in a Member State in the three previous years, or
-where use is made of an analysis technology which has not been used for three previous years to be used permanently in the case of an examination or other parameter;
i. Manufacturer: the person, including legal person, or his authorised representative, who:
1 °. is responsible for the design, manufacture, packaging and labelling of an in vitro diagnostic for placing on the market under its own name, regardless of whether these operations are carried out by the same person or under his or her own responsibility by a third party will be carried out; or
2. one or more prefabricated products assembles, packages, treats, innovates or labels, or, for the purposes of marketing these products on their own behalf, assembles to be used for in vitro purposes;
j. Delegate: the person established in a Member State, including legal person who, after having been expressly appointed by the manufacturer, acts on behalf of the manufacturer and is able to be sued in his place in law with respect to the person established in the Member State. obligations imposed on the manufacturer by or pursuant to this Decision;
k. Destination: the use to which the in vitro diagnosis is intended according to the manufacturer's instructions on the label, instructions for use or in the promotional material;
l. placing on the market: to deliver, for the first time, the payment or free of charge of an in vitro diagnostic device not intended for performance evaluation, for the purpose of distribution or use in the market of a Member State, whether or not it is a new one or a revamped in vitro diagnosis;
m. Notified body: the body designated for the implementation of Article 15 of the Directive;
n. 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;
o. Directive: Directive No 98 /79/EC the European Parliament and of the Council of 27 October 1998 concerning medical devices for in vitro diagnostic medical devices (PbEG L 331), to the text as set out in that Directive;
P. CE marking: the marking in accordance with the model set out in Annex X to the Directive.
2 Under an in vitro diagnosis, it is also understood:
-a container for specimens,
-a product for laboratory use, from the characteristics of which it is established that the manufacturer is specifically intended to be used for in vitro diagnostic tests.
3 Under an auxiliary piece is not understood one under the application of the Medical Devices Decision invasive medical device for the taking of specimens, as well as a medical device that is directly brought into contact with the human body to obtain specimens.
4 Under a manufacturer, it is not understood to include a person, including legal person, who assembles in vitro diagnostics that have already been placed on the market for an individual patient, or adjusts according to their intended purpose.
5 An amendment to one or more Annexes to the Directive shall apply to the application of this Decision as from the day on which the amendment in question must be carried out.
1 This Decision shall also apply to the aid and to the software required for the proper functioning of the in vitro diagnosis.
2 This Decision does not apply to an in vitro diagnosis applied solely by one and the same institution within the meaning of Article 1, 1st paragraph, Law quality, complaints and disputes care and within the premises in which it is manufactured or in an enacting space, without delivery to any other legal person.
1 The manufacturer shall be prohibited from holding or delivering an in vitro diagnosis if the presence of the product concerned has not been met by the manufacturer. Articles 4 to 8 and 10 .
2 It is prohibited to have any in vitro diagnosis or delivery of an in vitro diagnosis if the in vitro diagnosis has not been complied with in the Articles 12 and 13 .
3 It is prohibited to apply an in vitro diagnosis for the first time if the in vitro diagnosis does not comply with the requirements of the Articles 4 to 8 , 10 , 12 and 13 was delivered.
4 It is prohibited to provide users with high risk diagnostics to users other than those listed below:
a. A doctor;
b. A pharmacist.
1 The manufacturer who places on the market an in-vitro diagnostic service shall communicate to 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 ;
b. relating to the reagents, reactive products, calibration and control material, data in terms of common technological characteristics or substances to be examined, and any significant changes thereto, with including termination of placing on the market;
c. in relation to the other in vitro diagnostics, the appropriate data;
d. in respect of in vitro diagnostics referred to in Annex II to the Directive, as well as in vitro diagnostic diagnostics for self-testing:
-any data identifying the in-vitro diagnostic diagnostic in vitro,
-the analytical and, where appropriate, the diagnostic parameters referred to in Annex I, Part A, point 3 of the Directive,
-the results of the performance evaluation referred to in Annex VIII to the Directive,
-the certificates and any substantial amendments thereto, including the cessation of marketing.
2 Where the notification referred to in paragraph 1 relates to a new type of in vitro diagnosis bearing the CE marking, the manufacturer shall indicate this in the notification. In this case, the public authority referred to in the first paragraph may require, for two years after the marketing of that in vitro diagnosis by the manufacturer, that it submits a report on the experience gained from the in vitro diagnosis. to.
3 The manufacturer established outside a Member State shall designate an authorised representative.
1 An in vitro diagnosis shall comply with the requirements set out in Annex I to the Directive, taking into account the use of the in vitro diagnosis.
2 Our Minister, in implementation of Article 5 of the Directive, designates common technical specifications for the fulfilment of the in vitro diagnostics listed in Annex II, Annex II, List A, of the Directive and, where appropriate, in vitro diagnostics listed in Annex II, list B, of the Directive shall be considered to comply with the requirements set out in paragraph 1.
3 Our Minister shall designate standards for the implementation of Article 5 of the Directive, in the case of compliance with in-vitro diagnostics of compliance with the requirements of the first paragraph.
4 The references of the common technical specifications and standards identified shall be published in the Official Journal.
1 The information to be provided to the user listed in Annex I, Part B, point 8 of the Directive is drawn up in the Dutch language.
2 If the in vitro diagnosis is intended to be delivered exclusively to an institution where a professional environment in vitro diagnosis is performed, the information referred to in that paragraph may, by way of derogation from the first paragraph, be used in the English language of the English language, language has been prepared, under the condition that the person who first applies the in vitro diagnosis has an adequate control of the English language.
3 If an in vitro diagnosis is intended to be delivered to a user established in another Member State and delivered to the in vitro diagnosis for the first time, the first member may, by way of derogation from the first paragraph, be given the choice of the information referred to shall be drawn up in the language established by that Member State.
1 An in vitro diagnosis is marked with the CE marking.
2 An in vitro diagnosis 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 an in vitro diagnostic.
4 By way of derogation from the first paragraph, an in vitro diagnostic device intended for performance evaluation shall not bear the 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 III, IV, VI and VII to the Directive or of the notified body which is the notified body which has performed procedures.
6 The CE marking and the identification number referred to in paragraph 5 shall be affixed visibly, legibly and indelibly to the in vitro diagnosis, provided that it is technically feasible, on the instructions for use and on the packaging in which it is intended to be used. In vitro diagnostics are placed on the market.
7 An in vitro diagnosis is not labelled or inscription which could create confusion as to the meaning or graphic design of the CE marking; if on the in vitro diagnosis, the packaging or the packaging The instructions for use of other markings shall not reduce the visibility and legibility of the CE marking.
1 This Article shall not apply to an in vitro diagnostic device intended for performance evaluation purposes.
2 For the assessment of the in vitro diagnosis of in vitro diagnosis in Annex II, under list A, of the Directive Article 5, first paragraph , the manufacturer shall, in order to affc the CE marking, follow one of the following procedures:
(a) the procedure relating to the EC declaration of conformity set out in Annex IV to the Directive; or
(b) the procedure for EC-type examination, as defined in Annex V to the Directive, in conjunction with the procedure for the EC declaration of conformity set out in Annex VII to the Directive.
3 For the assessment of the in vitro diagnosis of in vitro diagnosis in Annex II, under List B, to the in vitro diagnosis of the Article 5, first paragraph , the manufacturer shall, in order to affc the CE marking, follow one of the following procedures:
(a) the procedure relating to the EC declaration of conformity set out in Annex IV to the Directive, with the exception of the procedure laid down in points 4 and 6 of that Annex; or
(b) the procedure for EC-type examination as defined in Annex V to the Directive in combination with
1 ° or the EC-label procedure set out in Annex VI to the Directive;
2 ° or the procedure relating to the EC declaration of conformity set out in Annex VII to the Directive.
4 For the assessment or an in vitro diagnosis intended for self-testing, to the in vitro diagnosis Article 5, first paragraph The manufacturer shall follow the procedure laid down in Annex III to the Directive as regards the EC declaration of conformity or the procedure referred to in the second or third paragraph, as specified in Annex III to the Directive. If the manufacturer follows the procedure set out in Annex III to the Directive, it shall draw up the declaration of conformity referred to in that Annex before the marketing of the in vitro diagnosis.
5 For the assessment or any in vitro diagnosis, other than those specified in the second to the fourth member, to the in vitro diagnosis, Article 5, first paragraph ' The manufacturer shall comply with the procedure laid down in Annex III to the Directive on the EC declaration of conformity, with the exception of the procedure laid down in point 6 of that Annex, as provided for in Annex III to the Directive. Before placing the in vitro diagnostic on the market, he shall draw up the attestation of conformity referred to in that Annex.
6 Our Minister may, in application of Article 14 of the Directive or the following provisions:
-amend or extend the lists of in vitro diagnostics, as set out in Annex II to the Directive,
-designate, by way of derogation from the second to fifth paragraph, for the assessment of an in vitro diagnosis or in a category of in vitro diagnostics, one or more of the other procedures referred to in those paragraphs shall be indicated.
7 In case of a conformity assessment procedure, the manufacturer shall refer to a notified body of his choice in the context of the tasks for which the notified body is notified.
8 During the conformity assessment procedure, the manufacturer and, where the latter is involved, 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 the conformity assessment procedure. of this Decision took place at an intermediate stage of manufacture. The notified body shall also take into account all relevant information concerning the characteristics and performance of the in vitro diagnostics and, in particular, the results of any relevant tests and inspections already carried out. in accordance with the relevant provisions as they applied immediately before the date of entry into force of this Decision.
9 The manufacturer shall keep the EC declaration of conformity referred to in the second to fifth paragraph, the technical documentation referred to in Annexes III to VIII of the Directive and the acts drawn up by the notified body; reports and certificates for a period of five years after the date of manufacture of the last in vitro diagnosis, at the level of the in vitro diagnosis Article 4, first paragraph , public authority.
10 The manufacturer shall provide the notified body with any information which may reasonably be required for the performance of its task.
11 A decision taken pursuant to Annexes III, IV or V 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 for a maximum period of five years by periods of a maximum period of time.
12 The provisions of this Article and of Article 3, third paragraph , shall apply mutatis mutandis to a person, including legal person, who manufactures an in vitro diagnosis and applies for the first time without delivering it.
13 The procedures referred to in the second to fifth paragraph shall be treated in the same way as the competent authorities of the other Member States in the framework of the Directive.
1 In implementation of Article 15 of the Directive, our Minister may designate one or more authorities to Article 8 carry out the procedures referred to, but only if they comply with the criteria set out in Annex IX to the Directive. In each case, such designation shall indicate the specific tasks of the body.
2 Our Minister shall designate standards for the implementation of the Directive when a body is considered 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 4, first paragraph If necessary, the public authority shall inform the public authority thereof.
4 The authority shall, on request, inform the Article 4, 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 15 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 first, third and fourth members, or the rules provided by the Minister under the fifth paragraph.
1 For the in vitro diagnostics intended for performance evaluation, the manufacturer shall follow the procedure set out in Annex VIII to the Directive and prepare the declaration referred to in that Annex before the in-vitro diagnosis of the in vitro diagnosis -to set
2 By way of derogation from Article 5, first paragraph , there is no need to meet the requirements set out in Annex I to the Directive for an in vitro diagnosis intended for performance evaluation, at the point of the study, and other aspects mentioned by the manufacturer.
The Articles 5 , 6 and 7 shall not apply to in vitro diagnostics presented at fairs, exhibitions, demonstrations and similar occasions, provided that:
-these in vitro diagnostics do not apply to specimens from the participants on those occasions, for the first time,
-it is clearly and visible that the in vitro diagnostics do not comply with the provisions of this Decision and cannot be delivered and applied for the first time before the manufacturer complies with the provisions of this Decision. Agreement has been reached.
The Article 3, second paragraph The person referred to above shall ensure that in vitro diagnostics he holds are retained in a proper, satisfactory, orderly manner and in accordance with the conditions laid down in Annex I, Part B, point 8.4. (h) of the Directive.
An in vitro diagnosis is provided by the in Article 3, second paragraph , the person referred to was not delivered:
a. In case the in vitro diagnostic efficacy diagnosis is intended, if not fulfilled, Article 10 ;
(b) where the in vitro diagnostic has been placed on the market:
-if it is not the one in the Article 5, first paragraph , 6, first paragraph , and 7, first paragraph , complies with the said requirements;
-after the expiry date referred to in point 8.4 of Annex I, point 8.4, point (e) of the Directive.
1 Pharmacists exercising their profession in a pharmacy shall issue a high risk diagnosis to a user, subject to the second and third paragraphs.
2 The high-risk diagnosis is provided by a package leaflet prepared by the manufacturer, which contains the following additional information:
-adequate guidance on the severity of the possible condition and on the importance of medical supervision in the use of the high risk diagnosis system;
-a instructions for use, sufficiently accessible to the non-professional user in order to use the high risk diagnosis correctly and to interpret the test results correctly;
-a presentation of the test results in a manner easily understood by the non-professional user,
-information on the possibility of false positive or false negative results;
-an opinion on measures to be taken in the event of a positive, negative or unambiguous result;
-an opinion that the user does not make a medical decision without consulting a doctor, quoting the relevant professional assistance agencies.
3 The delivery is preceded by information on:
-the possibility of using anonymous testing in the context of medical supervision,
-the importance of medical supervision where the test produces a positive result;
-the correct use of the high-risk diagnostic system,
-the correct interpretation of the test results.
1 By way of derogation from Article 3, first paragraph , until 7 December 2003, the manufacturer is allowed to have or to deliver in vitro diagnostic tests if, as regards the in vitro diagnosis, compliance with the requirements laid down in or under the law as applied to 6- December 1998.
2 By way of derogation from Article 3, second paragraph , the person referred to in that paragraph shall be allowed to have the presence of the in vitro diagnosis referred to in paragraph 1 until 7 December 2005 or to deliver it if, in respect of that in vitro diagnosis, the presence of the in vitro diagnosis has been complied with or the law has been complied with in vitro diagnosis. rules laid down in force on 6 December 1998.
3 By way of derogation from Article 3, third paragraph , it is permitted to apply in vitro diagnostics for the first time which were delivered before 6 December 1998 or which were delivered in accordance with the first or second paragraphs.
4 As regards the in vitro diagnostics referred to in the preceding paragraphs, on which this Decision is not applied and to which a CE marking is applied by virtue of one or more legal arrangements, shall be applied to the in vitro diagnostic tests. Documents, manuals or instructions for use shall state the references of the directives which are the basis of those legal arrangements published in the Official Journal of the European Communities.
This Decision shall enter into force on the second day following the date of issuance of the Official Gazette.
This Decision is cited as: Decision in vitro diagnostics.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 22 June 2001
Beatrix
The Minister for Health, Welfare and Sport,
E. Borst-Eilers
Published the 28th August 2001The Minister of Justice,
A. H. Korthals
