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Decree Of 15 March 2010 Amending The Decree Of 20 April 2006 Laying Down The Rules For The Classification Of Medical Devices Made In Application Of Article R. 5211-7 Of The Code Of Public Health

Original Language Title: Arrêté du 15 mars 2010 modifiant l'arrêté du 20 avril 2006 fixant les règles de classification des dispositifs médicaux, pris en application de l'article R. 5211-7 du code de la santé publique

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Texts transposed

Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the legislation of the Member States on active implantable medical devices, Council Directive 93/42/EEC on medical devices and Directive 98/8/EC on the marketing of biocide products (Text of interest for EEA)

Summary

Complete transfer of Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the legislation of the Member States on active implantable medical devices, Council Directive 93/42/EEC on medical devices and Directive 98/8/EC on the marketing of biocide products (Text of interest to EEA).

Keywords

HEALTH , EUROPEAN DIRECTIVE , COMPLETE TRANSPOSITION


JORF n°0063 of 16 March 2010 page 5000
text No. 48



Order of March 15, 2010 amending the Order of April 20, 2006 setting the classification rules for medical devices, pursuant to section R. 5211-7 of the Public Health Code

NOR: SASP1006019A ELI: https://www.legifrance.gouv.fr/eli/arrete/2010/3/15/SASP1006019A/jo/texte


Minister of Health and Sports,
Having regard to Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the legislation of the Member States on active implantable medical devices, Council Directive 93/42/EEC on medical devices and Directive 98/8/EC on the marketing of biocide products;
Having regard to Council Directive 93/42/EEC of 14 June 1993 on medical devices, including Annex IX;
Vu le Public Health Codearticles L. 5211-6, R. 5211-7 to R. 5211-11;
In view of the decision of 20 April 2006 setting the classification rules for medical devices, taken under theArticle R. 5211-7 of the Public Health Code ;
On a proposal by the Director General of the French Health Products Agency dated 27 October 2008,
Stop it!

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The above decision of 20 April 2006 is amended to read:
I. - After the third paragraph of item 1.1 of Schedule I, the following paragraph is added:
"For the calculation of the duration, the term "used continuously" must be heard in the sense of an uninterrupted effective use of the device in accordance with its destination. However, when a device ceases to be used to be replaced immediately by the same device or by an identical device, this new period should be considered as an extension of the continuous use of the device. »
II. - After the last sentence of item 1.4 of Annex I, the following sentence is added: "Every autonomous software is considered an active medical device. »
III. - The second paragraph of item 1.7 of annex I is as follows:
" Pulmonary arteries, ascending aorta, aortic cross, descending aorta to aortic forks, coronary arteries, primitive carotide artery, external carotid arteries, internal carotid arteries, brain arteries, brachio-cephalic trunk, coronary sinus, pulmonary veins, upper cellar vein, lower cellar vein. »
IV. - In Appendix II, item 2.1, the first paragraph is as follows:
"All invasive devices related to the orifices of the body, other than invasive surgical-type devices, which are not intended to be connected to an active medical device or are intended to be connected to an active medical device of Class I:".
V. - Item 2.2 of Appendix II is amended as follows:
1. The first drawer is thus written:
"if specifically intended to control, diagnose, monitor or correct a failure of the heart or central circulatory system by direct contact with these parts of the body, in which case they are part of Class III; "
2. After the second dash, a dash is inserted as follows:
"if specifically intended to be used in direct contact with the central nervous system, in which case they are part of Class III; "
VI. - In Appendix II, item 2.3, the first dash is as follows:
“– specifically to control, diagnose, monitor or correct a central heart failure or circulatory system by direct contact with these parts of the body, in which case they are part of Class III; "
VII. — The second paragraph of item 4.3 of Schedule II is as follows:
"All devices specifically designed to disinfect medical devices are part of Class II a unless specifically intended to disinfect invasive devices in which case they are part of Class II b."
VIII. - In Appendix II, item 4.4, the words "non-active" are deleted.

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The provisions of this Order come into force on 21 March 2010.

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The Director General of the French Health Products Safety Agency is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.


Done in Paris, March 15, 2010.


For the Minister and by delegation:

The Director General of Health,

D. Houssin


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