RegionWhat is MEDDEV 2.7 rev?
MEDDEV 2.7/1 Rev. 4 is a guidance document published by the European Commission that provides a common approach for manufacturers and notified bodies to conduct clinical evaluations of medical devices under the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Device Directive (AIMDD) 90/385/EEC
What are critical responsibilities of MEDDEV 2.7 rev?
- Conducted clinical evaluations and maintained the clinical evaluation report as part of the device’s technical documentation.
- Ensure clinical evaluations are carried out by suitably qualified individuals with specific education and experience requirements.
- Update clinical evaluation reports at least annually for high-risk devices and every 2-5 years for lower-risk devices or whenever new post-market data becomes available.
- Establish clear, measurable objectives for the clinical evaluation linked to device performance, safety, and risk-benefit endpoints.
