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

5.2. The PMPF plan shall include at least: U.K.

(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.