The focus is on
- Article 15 on the person responsible for compliance with regulatory requirements
- Article 18 on the implant card.
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.
- legal design requirements
- information to be provided by the manufacturer
- the use of symbols
Appendix 1 contains helpful examples of practical implementation.