Will your CER meet the new requirements?
Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use. Worldwide regulatory requirements prescribe how such Clinical Evaluation needs to be completed. Specific regulatory requirements regarding Clinical Evaluation exist for example, in the US, EU and China.
Key principles of Clinical Evaluation are the same in the different regulatory regions.
The objective of the presentation is to discuss Clinical Evaluation and the concept of equivalence, with a focus on the recent publications of the European MEDDEV 2.7.1/rev 4.
Answers will be provided to the following questions:
- To what extent can the principles of equivalence be applied to innovative products?
- What are MEDDEV 2.7.1/rev 4 expectations regarding scoping of the Clinical Evaluation?
- What are the requirements regarding competencies and skills of the medical writing team?
- How to keep your Clinical Evaluation- and Risk Management documentation up to date?
Anna Pietersma, PhD