Understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR – (EU) 2017/745), MEDDEV 2.7/1 Revision 4, and relevant Medical Device Coordination Group (MDCG) guidance documents is now critical for all manufacturers.
Join this webinar to hear Richard Holborow, Global Head of Clinical Compliance for BSI, talk about:
- The clinical evaluation process at BSI and the clinical team involved.
- Critical areas of the Clinical Evaluation Report (CER) along with some expanded information about what notified bodies expect to see under the MDR.
- How to present ‘State of the Art’ for your submission.
- Critical points for the additional documentation required under MDR and how these documents affect manufacturers and where they should fit into their document cycle: Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Report (PSUR) and Clinical Evaluation Assessment Report (CEAR).The main messages from updates including coverage of MDCG 2019-9, MDCCG 2020-7, MDCG 2020-8, and MDCG 2020-13.