The aims of the PMCF are:
- 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 findings of the PMCF will be analysed by the manufacturer and the results documented in a PMCF evaluation report. The PMCF evaluation report will be part of the clinical evaluation report and the technical documentation.
The acceptability of the PMCF plan and its application is subject to assessment by the notified body. The notified body’s assessment of the clinical evaluation will also cover the manufacturer’s procedures and documentation of the PMCF.
It is role of the notified body to assess the justification provided by the manufacturer in relation to non-performance of PMCF.