The French Notified Body LNE/G-MED has issued its calendar for implementation of the MEDDEV 2.7.1 for Clinical Evaluation, published in April 2016 in their audit requirements.
Although the MEDDEV guidance has been applicable since its publication, G-MED will apply the following deadline for its assessment during audits:
- From 1st February 2017, during annual audits, auditors will check that manufacturers have performed a gap analysis and set up an action plan for the update of the Clinical Evaluation report of medical devices according to the new guidance, regardless of their class and assessment procedure.
- From 1st July 2017, Clinical Evaluation must be presented according to the new MEDDEV guidance for each device assessed under Annex III (EC type examination procedure) and Annex II.4 (Examination of design of the product). It applies to initial assessment, renewal of certification or assessment of changes impacting clinical data.
In order to help manufacturers, LNE/G-MED has published a guidance document for the presentation of Clinical Evaluation report in French.
The original information from LNE/G-MED website and the link to download the French guidance can be found here.
Contact us if you need any help updating your Clinical Evaluation report.