News about GMP/cGMP


MDR/IVDR: Two guideances published on Art. 15 and 18

On 1 July 2019, the Medical Device Coordination Group (MDCG) published two guidance documents on the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR).

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