Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

The European Commission seemingly wants to catch up with the shortfalls of the last years. Late April, the following guidance documents for Regulation (EU) 2017/745 on medical devices (MDR) have been published. Please review carefully as they may be important for your transition, especially regarding clinical evaluations:

  • MDCG 2020-5
    Clinical Evaluation – Equivalence
  • MDCG 2020-6
    Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC
  • MDCG 2020-7
    Post-market clinical follow-up (PMCF) Plan Template
  • MDCG 2020-8
    Post-market clinical follow-up (PMCF) Evaluation Report Template

Furthermore, in the course of the COVID-19 crisis, the Commission has issued guidance on certain product types that are urgently required in the given situation:

  • MDCG 2020-9
    REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES

It is a challenging time, which makes it difficult to keep track with all developments. Should you have any questions, please don’t hesitate to get in touch.

Sources: MDCG guidance documents

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