Learn more about this text...

Information on this text

Summary

Application des directives 90/385/CEE du 20 juin 1990 concernant le rapprochement des législations des Etats membres relatives aux dispositifs médical implantables actif et 93/42/CEE modifié du Conseil du 14 juin 1993 relative aux dispositifs médical. The purpose of this Order is to define the medical devices (DMs) of which all the documents enabling them to be identified must be communicated to the French Health Safety Agency (AFSSAPS) when they are put into service in French territory. This decree is implemented pursuant to Article L. 5211-4 of the Public Health Code, in its new wording from Article 95 of Law 2002-303 of 4 March 2002 on the rights of the sick and the quality of the health system. Prior to the Act of 4 March 2002, section L. 5211-4 provided that DMs with a certification of compliance with essential requirements for the safety and health of patients, users and third parties, but whose design or manufacture could be at the origin of particular health risks, were to be reported to the AFSSAPS three months before they were placed on the market. This provision, adding to the conformity certification a precondition for placing on the market, could not be compatible with community law. In order to allow the AFSSAPS to know as quickly as possible the entire DM. the most sensitive ones present in the French market, while remaining consistent with the Community law set out in amended Directive 93/42ICEE of 14 June 1993, Article L. 5211-4 now provides that all parts of the medical devices that have a high risk potential for human health must be communicated to the AFSSAPS when they are put into service in the national territory. The I of Article 1 of this Decree amends Article R. 665-5 of the Public Health Code in order to introduce the definitions of the agent of the manufacturer, the distributor of DM and the commissioning of DM. These definitions are indeed made necessary to the extent that the purpose of this decree is to allow the AFSSAPS to know as soon as possible the whole of the most sensitive models of the market, The definitions of a proxy and commissioning are in line with those set out in the 1993 directive referred to above; The definition of a distributor, on the other hand, is not equivalent.The II of Article 1 of the Order inserts an article R. 665-8-1 that determines the categories of medical devices to be the subject of the communication as Class IIb and Class III MDDs, as well as active implantable medical devices (MD1A). With respect to Class IIb or III MDDs, this provision is in accordance with Article 14 of Directive 93/42/EEC as amended by Directive 98/79/EC of 27 October 1998 on medical devices for in vitro diagnosis, which explicitly provides for the possibility for Member States to request the communication of these documents for Class IIb or Class III devices.The MDAs do not fall within the scope of Directive 93/42ICEE of 14 June 1993 on medical devices They are therefore not mentioned in Article 14 of Directive 931421EEC referred to above. The inclusion of DMIA in the framework provided for in this decree is, however, desirable in terms of health security, and is not contrary to the objectives of Directives 90/385/EEC and 93/42/EEC. In fact, it would be difficult to understand that, for market control and health safety reasons, implantable DMs, being with an exception close to Class IIb or III due to classification rules, must be reported to the AFSSAPS at their first commission, while active implantable medical devices that have the same level of danger as Class III DMs, are not subject to that obligation. Article R. 665-8-l sets out the list of elements to be the subject of the communication. This list of documents is limited to those necessary for the identification of the device: commercial name of the DM, name and address of the person performing the communication, labelling and instruction notice. Finally, section R. 665-8-1 recalls that, as provided by the law, when the DM concerned is a DM in the manufacture of which a product of animal origin occurs, the declaration mentions it and the species of origin. Article III of the Decree inserts an article R. 665-43-l which defines the criminal penalties applicable in the event of a breach of the obligation of communication provided for in this Decree. I of book V bis: art. R. 665-5 (insertion of 4°, 5° and 6°) from Decree 95-292 of 16-03-1995, after art. R. 665-8 insertion of an art. R. 665-8-1; in section IX insertion after art. R. 665-43 of an art. R. 665-43-1 of the Public Health Code.

Keywords

HEALTH , PUBLIC HEALTH CODE , MEDICAL DISPOSITIF , DM , IMPLANTIVE MEDICAL DISPOSITIF , DMIA , IDENTIFICATION , COMMUNICATION , AFSSAPS , MISE IN SERVICE , MANDATE , FABRICAN , DISTRIBUTEUR , MISE ON THE MARK

---

JORF n°231 of 3 October 2002 page 16348
text No. 24



Decree No. 2002-1221 of 30 September 2002 on the categories of medical devices to be transmitted during their commissioning and amending Book V bis of the Public Health Code (Part Two: Orders in the Council of State)

NOR: SANP0222418D ELI: https://www.legifrance.gouv.fr/eli/decret/2002/9/30/SANP0222418D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2002/9/30/2002-1221/jo/texte

The Prime Minister,
On the report of the Minister of Health, Family and Persons with Disabilities,
Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the legislation of member States on active implantable medical devices;
Having regard to Council Directive 93/42/EEC of 14 June 1993 on medical devices;
Considering the public health code, including articles L. 5211-4 and L. 5211-6 (5°);
Considering the penal code, including article R. 610-1;
The State Council (Social Section) heard,
Decrete:

Article 1 Learn more about this article...

Chapter I of Book V bis of the Public Health Code (Part Two: Decrees in the Council of State) is thus amended:
I. - In article R. 665-5, it is inserted a 4°, a 5° and a 6° as follows:
« 4° "Manufacture any natural or legal person established in a Member State of the European Community or a party to the Agreement on the European Economic Area that, after being expressly designated by the manufacturer, acts and may be contacted by the competent administrative authorities in place and place of the manufacturer with respect to the obligations that this book imposes on the manufacturer;
« 5° "Distributor means any natural or legal person engaged in the storage of medical devices and their distribution or export, excluding the sale to the public;
« 6° It is meant by "commissioning the provision of a medical device ready to be used for the first time in the community market, in accordance with its destination. »
II. - After the article R. 665-8, an article is inserted as follows:
"Art. R. 665-8-1. - Medical devices to be reported under Article L. 5211-4 are the medical devices of Class II b and III resulting from the classification rules set out in Appendix IX to this book, as well as active implantable medical devices.
"The communication referred to in the first paragraph shall be made with the Director General of the French Health Product Safety Agency during the commissioning on the national territory by the manufacturers, agents or distributors who deliver medical devices directly to the end user. It includes:
“(a) The commercial name of the medical device;
“(b) The name and address of the communication person;
"(c) A copy of the labelling and instructions of the medical device referred to in Appendix I to this book.
"For medical devices in the manufacture of which a product of animal origin occurs, the communication specifies it and the species of origin. »
III. - In section IX, after article R. 665-43, an article R. 665-43-1 is inserted as follows:
"Art. R. 665-43-1. - I. - Is punishable by the fine provided for in contraventions of the 5th class by putting into service in the national territory a medical device of Class II b or III, or an active implantable medical device without the communication provided for in Article R. 665-8-1.
“II. - The recidivism of the offence defined in I of this article is punishable under section 132-11 of the Criminal Code.
"III. - Legal persons may be criminally liable under the conditions provided for in article 121-2 of the Criminal Code for the offence defined in I of this article.
"The penalty incurred by the legal person is the fine, under the conditions set out in section 131-41 of the Criminal Code. »

Article 2 Learn more about this article...

The Minister of Justice and the Minister of Health, Family and Persons with Disabilities are responsible, each with regard to the execution of this Order, to be published in the Official Journal of the French Republic.

Done in Paris, September 30, 2002.

Jean-Pierre Raffarin

By the Prime Minister:

Minister of Health, Family

and persons with disabilities,

Jean-François Mattei

The Seal Guard, Minister of Justice,

Dominica Perben

---

Download the document in RTF (weight < 1MB) Facsimile (format: pdf, weight < 3.5 MB) Download the document in RDF (format: rdf, weight < 1 MB)