Device Compliance with MEDDEV 2.7.1 Rev 4 for Clin Eval / CER
Speaker: Dr. Frank Turner
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use.
With the release of MEDDEV 2.7.1 Rev 4 June 2016 on clinical evaluations in Europe, the main challenges for device companies in developing CER is to ensure compliance to new requirements and making justification that the available data is sufficient to support the performance and safety of a device.
This 2 part webinar will take a closer look on new requirements and highlight the key changes introduced by as MEDDEV 2.7.1 Rev 4 for CER and options for you to gather clinical data from different sources and methods like PMCF & Registries
Part I of the webinar covers:
- New Requirements for MEDDEV 2.7.1 Rev 4
- Most significant changes in Rev 4
- Evaluation of Risk-Benefits profile
- Impact on the CERs & device companies
- Process / Steps for you to consider
Webinar Part II: This will cover clinical data options when you can no longer use a predictive or equivalent device for data dependency for clinical evaluation. This webinar will also cover how to gather clinical data for your device in different methods. The date of the webinar part-II will be announced in June ending.