The focus is on
Article 15 of the MDR and IVDR requires companies to appoint at least one person responsible for compliance. The 5-page guideline MDCG 2019-7 explains in detail the criteria that must be met in this position.
Article 18 of the MDR deals with the information necessary on an implant card.
The 13-page document MDCG 2019-8 describes e.g.
Appendix 1 contains helpful examples of practical implementation.
Source: Guidance documents MDCG 2019-7 and MDCG 2019-8
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