Module 16 2024

24/10/2024

EU MDR Notified Body Involvement in PMS

Review of the PMS Plan • Article 84: For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.

Review of Preventive and Corrective Actions • Article 83 (4): Where applicable, the NB must be informed by the manufacturer of any preventive and corrective actions taken.

Review of Periodic Safety Update Reports (PSUR) • Article 86 (2): For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notif ied body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.

Provision of Information and Assessments • Via EUDAMED – or via NB surveillance audits per MDCG 2022-14

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

19

19

Notified Body role in vigilance EU MDR Annex VII

4.10 Surveillance activities and post-certification monitoring

The notified body shall have documented procedures:

The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide which of the following options to apply: — not to take action on the basis that the vigilance case is clearly not related to the certification granted, — observe the manufacturer's and competent authority's activities and the results of the manufacturer's investigation so as to determine whether the certification granted is at risk or whether adequate corrective action has been taken, — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk, — increase the frequency of surveillance audits, — review specific products or processes on the occasion of the next audit of the manufacturer, or — take any other relevant measure.

— to review vigilance data to which they have access under Article 92(2) in order to estimate its impact, if any, on the validity of existing certificates . The results of the evaluation and any decisions taken shall be thoroughly documented.

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

20

20

10