Module 16 2024

24/10/2024

Agenda

What are the UK Medical Device Regulatory Requirements for medical devices

01

Overview of draft PMS SI and new UK PMS requirements

02

03

Role of the AB / NB in PMS & Vigilance

04

PMS & Vigilance Guidance

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

2024-10-24

15

15

Draft PMS SI Approved Body Involvement in PMS

Review of the PMS Plan • The UKAB must review the manufacturer's PMS plan as part of the ongoing surveillance process. This includes assessing whether the plan is in line with the requirements and if it adequately addresses the manufacturer's obligations. Review of Preventive and Corrective Actions • The UKAB must be informed by the manufacturer of any preventive and corrective actions taken after device certification or declaration of conformity. The UKAB must review the notification to determine whether there is any impact on the certification it has issued for the device. Review of Periodic Safety Update Reports (PSUR) • For certain device classifications, such as Class III medical devices and Annex II list A and B IVDs, the UKAB must review the PSUR prepared by the manufacturer. They will determine if there is any impact on the validity of the device certification and provide details of any necessary action. Provision of Information and Assessments • The UKAB must provide MHRA • information and assessments relevant to serious incident and field safety corrective actions upon request. • completed PSUR assessment reports within 3 working days of the date of any such request.

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

2024-10-24

16

16

8