Commission Publishes Update of MEDDEV 2.12/2 on Post Market Clinical Follow-Up (PMCF) Studies
Quality First International draws attention to the revised guideline that provides instructions on how to fulfil post-market surveillance obligations according to the Medical Devices Directive 93/42/EEC and how to address issues linked to residual risk
London, 6 February 2012
The European Commission has published an update of MEDDEV 2.12/2 entitled Post Market Clinical Follow-Up Studies - A Guide for Manufacturers and Notified Bodies, dated January 2012.
The guidance provided in the updated MEDDEV follows the recommendations of the Global Harmonization Task Force and references the 2011 update of EN ISO 14155. It also reflects the changes introduced by Directive 2007/47/EC. MEDDEV 2.12/2 rev 2 provides specific advice on:
- The circumstances where a PMCF study is indicated;
- The principles of PMCF studies involving medical devices;
- The use of study data; and
- The role of a Notified Body in the assessment of PMCF plans and of the results obtained from the plans as part of conformity assessment.
The guidance does not apply to in vitro diagnostic devices.
One of the goals of the second revision of MEDDEV 2.12/2 is to emphasise the importance of the appropriate use and conduct of PMCF studies to address issues linked to residual risk.
“Although PMCF studies are conducted using devices carrying the CE mark of conformity within their intended use, the provisions of section 2.3.5 of Annex X to Directive 93/42/EEC do not apply; however, the requirements in Directive 93/42/EEC concerning notification of adverse events after placing a device on the market apply fully,” explains Haroon Atchia from Quality First International. “Manufacturers of medical devices must be aware that compliance with these notification provisions is necessary in order to fulfil legal obligations under European legislation. Further, manufacturers should recall the conditions of the General Product Safety Regulations; therefore, PMCF constitutes only part of the obligations on post-production obligations”.
A full copy of the guidance document may be downloaded
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
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