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.

Source: Guidance documents MDCG 2019-7 and MDCG 2019-8