Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn

4.11. Re-certification U.K.

The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years.

The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:

(a)

all changes to the originally approved device, including changes not yet notified,

(b)

experience gained from post-market surveillance,

(c)

experience from risk-management,

(d)

experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,

(e)

experience from reviews of the performance evaluation, including the results of any performance studies and PMPF,

(f)

changes to the requirements, to components of the device or to the scientific or regulatory environment,

(g)

changes to applied or new harmonised standards, CS or equivalent documents, and

(h)

changes in medical, scientific and technical knowledge, such as:

• new treatments,

• changes in test methods,

• new scientific findings on materials and components, including findings on their biocompatibility,

• experience from studies on comparable devices,

• data from registers and registries,

• experience from performance studies with comparable devices.

The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' performance evaluation reports.

For the decision on the re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps to be taken for certification, such as application and application review.