EU: Revised Guidance on Clinical Evaluation – MEDDEV 2.7.1 (rev. 4)
The European Commission published a revision of its guidance on the clinical evaluation of medical devices – MEDDEV 2.7.1 (rev. 4). The new version is substantially strengthened than the old document, which came into effect in December 2009.
The updated guidance, among others, specifies how often manufacturers should actively update the clinical evaluation of their devices and introduces an updated methodology for clinical evaluation. The guideline contains additional rules on demonstrating equivalence with other medical devices, which will be more harder now.
Last but not least, the role and actions required by the notified bodies are also specified in this document. Due to the significant changes being introduced by the new Medical Device Regulation (MDR) it is more likely that also this guidance will be further revised to align to the upcoming legal requirements.
You get the updated guidance under MEDDEV 2.7.1 (rev. 4).
- EU: Revised Guidance on Clinical Evaluation – MEDDEV 2.7.1 (rev. 4)
- EU: MDR-Medical Device Regulation – consolidated text
- Germany: Regulation on unannounced audits
- Canada: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ issued
- Malaysia: Class A devices exempted from conformity assessment; some other devices from registration requirements