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.
Key takeaways and learning objectives
- 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.
Join this webinar to hear Richard Holborow, Global Head of Clinical Compliance for BSI.