Join us on November 15th for this webcast being held in partnership with TOPRA.
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 regulatory submissions.
This guidance was published in June of 2016 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 (European Union) 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.
Many manufacturers struggle to achieve regulatory compliance under the new regulation because they don’t understand the data required or how to conduct the clinical evaluation. Failure to meet these requirements can jeopardize a manufacturer’s ability to market their device in Europe.
During the webcast, we will review MED DEV 2.7/1 REV 4, MDR, and the medical device coordination group guidance (MDCG) regarding clinical evaluation. We will review the stages and deliverables of clinical evaluation. We will explain the key components of a clinical evaluation, including state-of-the art, equivalence, systematic literature review, post market surveillance, post market clinical follow up, and identify types of clinical data that can be used to support your device under MDR.
Upon the conclusion of the program, you will be able to:
- Describe the applicable regulations and guidance documents related to clinical evaluation
- Identify the five stages of Clinical Evaluation
- Identify key components of clinical evaluation
Whilst TOPRA is facilitating this webinar for Certara this is not an endorsement of Certara, Certara’s affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.