The new Medical Device Regulation (MDR 2017/745) was adopted by the European Union in 2017 and will come into effect on 26 May 2020. It replaces the existing Medical Device Directive (MDD 93/42) and introduces a number of important changes, including the strengthening of post-marketing surveillance requirements. The new regulations state that medical device manufacturers must play an active role during the post-marketing phase, by implementing processes to actively and systematically collect, record and analyse data on the safety, quality and performance of the device throughout its expected lifetime.
These enhanced vigilance and market surveillance requirements mean that medical device manufacturers will need to collect data about the performance of their devices once they are available for use on the market. As part of this process some medical device manufacturers will need to conduct post market clinical follow-up (PMCF) studies.
Post market clinical follow-up studies are carried out following the CE marking of a device. They are intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labelling. Guidance on the conduct of PMCF studies is provided in MEDDEV 2.12/2 rev.2.
Clinical data obtained from post-market surveillance and during PMCF studies are critical for updating the clinical evaluation report throughout the life-cycle of the medical device to provide evidence of the long term safety and performance of the marketed device.
Post-market clinical follow-up studies evaluate the medical device when used in accordance with its intended purpose and instructions for use. Studies must be compliant with applicable laws and regulations, follow an appropriate methodology and should adhere to relevant guidelines and standards. The PMCF study design and methodology should be described in a clinical investigation plan (CIP) which will include a description of the rationale, objectives, endpoints, statistical methods and clinical processes which must be appropriate for addressing the stated objectives. A statistical analysis plan (SAP) giving a detailed description of the statistical methods is also required.
The study conduct should include adequate control measures to ensure compliance with the CIP. Data analysis should be performed in accordance with the SAP by someone with appropriate statistical expertise. The final clinical investigation report should describe the outcome of the statistical analysis and provide conclusions relating back to the planned objectives.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. https://publications.europa.eu/en/publication-detail/-/publication/83bdc18f-315d-11e7-9412-01aa75ed71a1/language-en/format-PDF/source-58036705
Guidelines on Medical Devices. Post Market Clinical Follow-up Studies. MEDDEV 2.12/2 rev2 January 2012