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.
This webinar was recorded on October 21, 2021.
Related services:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies