European Commission 24 September 2013, Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance

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European Union · · · Cited by 35 · 24-09-2013

Article 1. Definitions
Article 2. Interpretation of designation criteria
Article 3. Procedure for the designation of notified bodies
Article 4. Extension and renewal of designation
Article 5. Surveillance and monitoring
Article 6. Investigation of the competence of a notified body
Article 7. Exchange of experience on designation and supervision of conformity assessment bodies
Article 8. Operating of designating authorities
Article 9. Cooperation with accreditation bodies
Article 10. Entry into force and date of application
ANNEX I. Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC

25.9.2013

Official Journal of the European Union

L 253/8

COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013

of 24 September 2013

on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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