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.
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.