Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the d... (32013R0920)
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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
- 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)
- 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
- ANNEX II
- Application form to be submitted when applying for designation as notified body
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