Practical Aspects of Clinical Evaluation: What Needs to be Updated Now and How to Plan for Future Compliance Under the MDR

Clinical Evaluation is required for all medical devices, regardless of class pursuant to the medical device directives. This requirement was most recently reinforced by MEDDEV 2.7/1 rev. 4 which sets out clear guidelines for compliance. However, there is still a gap between the MEDDEV and the future requirements under MDR. This presentation will provide practical advice on issues to consider in performing the gap analysis to ensure that updated CERs are MDR compliant.