The MDR proposal will make Post-Market Clinical Follow-up (PMCF) mandatory as part of the clinical evaluation cycle for the device concerned, essentially implementing the PMCF MEDDEV 2.12/2 Rev2.
This is a further degree of harmonization because at the moment there are different approaches implemented in EU Member states.
PMCF is defined as a continuous process to update the clinical evaluation. It is repeatedly stated that this shall be part of the manufacturers’ post-market surveillance plan.
The manufacturer must analyze the findings of the PMCF and document the results in a PMCF - Evaluation Report that will be part of the technical documentation. It has now been proposed to amend this requirement such that this report should be sent periodically to the concerned Member States.
For class III devices and implantables this report shall be further reviewed by a third party or external expert under the principles of highest scientific competence and impartiality.
PMCF implies that the requirements for clinical evidence increases substantially and will require an significantly higher investment from medical device manufactures in employing staff who are knowledgeable in (a) regulatory affairs, (b) Good Clinical Practice (GCP) and (c) clinical investigation design in order to work with and interpret clinical studies. By hiring or employing a person responsible for regulatory compliance this QP is able to communicate with Competent Authorities and Notified Bodies.
Post Market (Clinical) Surveillance / Follow-Up
- Post-market follow-up, ... is a continuous process ... and shall be part of the manufacturer's post-market surveillance plan.
- To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device, which is authorized to bear the CE marking, within its intended purpose ... with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
MDR - Post Market Clinical Follow-Up
- '... PMCF shall be performed pursuant to documented method laid down in PMCF plan ...'
- 'specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data ...'
- 'The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.'
Elements of Post Market (Clinical) Surveillance / Follow-Up => Post Market Surveillance Plan - Content
- The plan shall define the source of data and the means to collect those data and shall be proportional to the risk of device/device family.
- The plan may include:
- Complaints Handling;
- Return Products Analysis
- Vigilance Reports
- Literature Review
- Registry Review
- Regulatory Feedback