On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/382/EEC”. The recently issued file replaces the 2009 version. It outlines clear guidelines for both manufacturers and Notified Bodies on how to conduct a clinical evaluation of medical devices.
What is MEDDEV 2.7/1?
The conduction of a clinical evaluation is currently mandatory in the EU for all classes of medical devices prior to affixing the CE mark. Any medical devices’ manufacturer is obliged to complete the clinical evaluation, which is documented in the clinical evaluation report (CER). CER is an integral part of the Technical File. The main aim of MEDDEV 2.7/1 is to set out guidelines concerning the purpose, methodology and necessary documentation of a clinical evaluation.
What has changed?
The 2016 version includes more detailed requirements for clinical data, acceptable methods, frequency of updates and the evaluation of CER.
Some of the key changes include, but are not limited to:
- preliminary stage of clinical evaluation added (referred to as ‘Stage 0’)
- clear deadlines for the frequency of clinical evaluation update (annually or every 2-5 years)
- revised definition of devices’ equivalence
- new requirements for the evaluators of clinical data
It is assumed that the new version of MEDDEV takes a step in the direction of the new Medical Devices Regulation. It will assist manufacturers in preparing for complying with the new requirements brought by the upcoming legislation.
Where can I access MEDDEV 2.7/1 text?
The entire text of the MEDDEV 2.7/1 is now available on the Obelis website in the Legislation section. If you wish to know more about clinical evaluation and the CE marking process for medical devices, feel free to contact us.
Katarzyna Piekarska