Novelties for Clinical Evaluation and Post Market Surveillance within MDR – the Posts Series
- December 10, 2020
- Posted by: confinis
- Categories: confinis, Regulations
The Medical Device Regulation (EU) 2017/745 (MDR) takes effects next year on 26th May 2021. Risk Management, Clinical Evaluation and Post-Market Surveillance activities are particularly affected by the enforcement of the MDR and they need to be aligned more than before.
How to do that?
In the last two years during the transition period for the enforcement of the MDR, more than 40 guidance were published by the medical device coordination group (MDCG) https://ec.europa.eu/health/md_sector/new_regulations/guidance_en. These are legally non-binding guidance documents, adopted by the MDCG in accordance with Article 105 of Regulation 745/2017 to ensure uniform application of the relevant provisions of the regulations within the EU.
In this series, confinis is proposing 6 blogs providing a quick, simplified, and critical summary of the most recent guidance related to the Clinical Evaluation and the Post-Market Surveillance activities.
In this series, #confinis is proposing 6 blogs providing a quick, simplified, and critical summary of the most recent guidance related to the Clinical Evaluation and the Post-Market Surveillance activities, including:
- “How to claim an equivalence in the clinical evaluation under the MDR” (How to claim an equivalence in the clinical evaluation under the MDR – confinis)
- “How to ensure sufficient clinical evidence for legacy devices” (How to ensure sufficient clinical evidence for legacy devices – confinis)
- “How to perform a clinical evaluation for Medical Device Software” (Clinical evaluation for Medical Device Software – confinis)
- “How doas a notified body assess your clinical evaluation?” (How does the notified body assess your clinical evaluation?)
- “How to plan your post-market clinical follow up…” (How to plan your post-market clinical follow up…)
- “…and How to report your Post-Market Clinical Follow-up evaluation” (… and Report your Post-Market Clinical Follow-up Evaluation! – confinis)
Stay tuned!
Feel free to reach out to us if you want to know more or to book an appointment: info.ch@confinis.com
Authors: Dr. Martina Coscia, Dr. Andrea Biasiucci