19.01.2012 – Revised MEDDEV on post-market clinical follow-up studies published
The European Commission has published on its website an official guidance document entitled ‘Post-market clinical follow-up studies – a guide for manufacturers and notified bodies’, reference MEDDEV 2.12/2 rev.2, January 2012, updating the previous version published in 2004.
The Introduction to the document explains that it aims to assist the performance of Post-Market Clinical Follow-up (PMCF) studies in order to fulfil the Post-Market Surveillance (PMS) obligations of the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).
The document provides specific guidance in relation to:
the circumstances where a PMCF study is indicated;
- the general principles of PMCF studies involving medical devices;
- the use of study data (for example to update instructions for use and labelling); and
- the role of a notified body for medical devices in the assessment of PMCF plans and of the results obtained from the plans as part of conformity assessment.
The guidance also clarifies that it does not apply to in vitro diagnostic devices covered by Directive 98/79/EEC.