NEWS FROM MDCG: four new documents:
This MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device on the market , for the purpose of CE-marking under the MDR.
One of the purposes of this document is to highlight the differences between the MDR and the MEDDEV 2.7/1 rev.4 specifically with regards to equivalence. It is also intended to provide additional guidance and support a harmonised approach to the demonstration of equivalence across the EU.
In addition, non-exhaustive guidance and references have been provided with respect to device considerations for medical devices incorporating an ancillary medicinal product.
This MDCG guidance also covers products without an intended medical purpose listed in Annex XVI of the MDR.
A PMCF plan shall specify the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from the use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.
The aim of the PMCF plan is:
confirming the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime;
identifying previously unknown side-effects and monitor the identified side-effects and contraindications;
identifying and analysing emergent risks on the basis of factual evidence;
ensuring the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR;
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
The PMCF plan shall be part of the post-market surveillance plan.
The purpose of the present templates is to guide manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report. This would assist manufacturers in a harmonised and complete presentation of post market clinical data and facilitate the activity of notified bodies and competent authorities in finding the information in an organized format.