2013/473/EU: Commission Recommendation of 24 September 2013 on the audits and ass... (32013H0473)
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2013/473/EU: Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices Text with EEA relevance
- COMMISSION RECOMMENDATION
- of 24 September 2013
- on the audits and assessments performed by notified bodies in the field of medical devices
- (Text with EEA relevance)
- (2013/473/EU)
- 1. PURPOSE
- 2. GENERAL GUIDELINES FOR AUDITS AND ASSESSMENTS
- 3. FOLLOW-UP
- 4. ADDRESSEES
- ANNEX I
- Product assessment
- ANNEX II
- Quality system assessment
- General advice in case of outsourcing of the production via subcontractors or suppliers
- ANNEX III
- Unannounced audits
- General advice with regard to contractual arrangements between the notified body and the manufacturer for the organisation of unannounced audits
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