Clinical Evaluation Reports (CER) for Medical Devices

The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR).  This scrutiny leaves some companies at risk for observations and nonconformities when transitioning from the Medical Devices Directive 93/42/EEC (MDD) to MDR.

Emergo by UL’s webinar will provide an overview of manufacturer responsibilities for clinical evaluation under the MDR, the clinical evaluation process including related Medical Device Coordination Group (MDCG) guidance on equivalence (MDCG 2020-5) and legacy devices (MDCG 2020-6), additional processes/documentation related to clinical evaluation and current experience in the MDR transition period.

 

Heather-Crawford
Heather Crawford
Senior Consultant, Quality and Regulatory Affairs (North America)

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This webinar was recorded on October 21, 2021.