Last June the European Commission published a new revision of the guideline MEDDEV 2.7.1 on Clinical Evaluation.
The updated guideline, replacing the previous of December 2009, describes the requirements in a more detailed and complete way, in order to execute an adequate clinical evaluation.
Some of the more important changes are:
- Direct match between the essential requirements and the clinical data to evaluate;
- Deep analysis of the clinical data during the entire life cycle of the device, from Design Controls to Post-market Evaluation;
- Detailed definition of equivalent device: the new revision highlights which documentation must be attached in order to demonstrate the technical, clinical and biological equivalence of the device, and include the relevant clinical data in the report;
- For each type of device a Stage 0 is foreseen, to establish a clinical evaluation protocol and plan.
The MEDDEV is already in force.