In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices.
This guideline was published and went into immediate effect without a transition period. Manufacturers were still evaluating the changes from the MEDDEV when the EC officially published the EU Medical Device Regulation (MDR) 2017/745 in the Official Journal of the European Union on 05 May 2017. The regulation affirms the expectations of the MEDDEV and expands on the clinical data requirements.
This live broadcast will explain the key changes affecting clinical evaluation, review the phases for clinical evaluation, explain expectations for a systematic literature review, and identify types of clinical data that can be used to support your device.
Angela Siebeneck has more than 30 years of clinical and regulatory experience. She began her career as a registered nurse in a hospital setting and has extensive experience in regulatory strategy, clinical and medical writing. Her experience with regulatory approvals spans Europe, Australia, the US and Asia. Siebeneck has authored or contributed to more than 100 MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Reports (CER), as well as postmarket surveillance (PMS) plans/reports, postmarket clinical follow up (PMCF) plans/reports, safety and performance evaluations, human factors studies and regulatory agency responses for medical devices. Her experience encompasses several areas including vascular access, orthopedics, interventional radiology, ophthalmic surgery and surgical instruments.