Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

PART B POST-MARKET PERFORMANCE FOLLOW-UP

4. PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence.

5. PMPF shall be performed pursuant to a documented method laid down in a PMPF plan.

5.1. The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of:

(a)

confirming the safety and performance of the device throughout its expected lifetime,

(b)

identifying previously unknown risks or limits to performance and contra-indications,

(c)

identifying and analysing emergent risks on the basis of factual evidence,

(d)

ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and

(e)

identifying possible systematic misuse.

5.2. The PMPF plan shall include at least:

(a)

the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data;

(b)

the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies;

(c)

a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);

(d)

a reference to the relevant parts of the performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I;

(e)

the specific objectives to be addressed by the PMPF;

(f)

an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;

(g)

reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and;

(h)

a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer.

6. The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation.

7. The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.

8. If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report.