Notes

Slide Show

Outline

1	Swiss Agency for Therapeutic Products Rainer VOELKSEN Head Medical Devices Division
2	General introduction Medical Devices Division Mutual Recognition Agrements European Regulatory System Links and Information Sources
3	New Federal Institute
4	Different players
5	Members of the Institute Council Dr.med. Peter Fuchs (President) Prof.Dr.med. Michel Burnier Surgeon, CHUV Dr.jur.Adv. Carlo Conti Cant. Auth. BS Dr.med.vet. Markus Dürr Cant. Auth. LU Anne-Sylvie Fontannaz Cant.Pharm. VD Prof.Dr.jur. Reinhold Hotz University Prof. Dr.med. Christiane Roth-Godat Admin. Dir. USZ
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7	Legislative basis
8	Therapeutic products
9	Core duties
10	Our services
11	Authorizations / licences
12	Market monitoring
13	Control of production and trade
14	Partners
15	International cooperation
16	Funding
17	Medical Devices Division
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20	Essential Requirements The very general essential requirements are in the annex I of each directive. The verification of the fulfilment of the essential requirements is delegated to state-controlled “Notified Bodies”. They perform the pre-market review of the product (with the exception of low-risk devices). All post-markering controls like vigilance, market surveillance etc. is performed by the Competent Authority.
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23	M R A Mutual Recognition Agreements
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26	Mutual Recognition Agreements trade-policy instruments for the elimination of barriers to trade recognition of conformity-assessments in the exporting country assessment against the regulations of the importing country recognition of equivalence of conformity assessment bodies
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32	European Regulatory System
33	Implementation of EU Directives Dir. 90/385/EEC on Active Implantable Medical Devices Dir. 93/42/EEC on Medical Devices Dir. 98/79/EC on In-vitro Diagnostic Medical Devices IVD Acceptance of the CE-Marking in Switzerland since May 1996
34	Definitions The largest group of medical devices is defined based on Annex IX of directive 93/42/EC into different risk classes. (see also GHTF doc. ) Classification in countries outside the EU/EEA/EFTA may be different.
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40	Sources, Links, Information
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44	Contact Swissmedic Medical Devices Division Erlachstrasse 8 CH - 3000 Berne 9, Switzerland Phone +41 31 323 22 51 Fax +41 31 322 76 46
45	Thank you