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

23

23

Available guidance

UK MHRA Guidance

EU Guidance

Current & Future?

MDCG 2023 3

• Medical devices: guidance for manufacturers on vigilance - GOV.UK

• Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

• Future MHRA guidance to support PMS SI?

MDCG 2022 21

• Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

• DSVG Artificial heart valves • DSVG Blood glucose meters

Device Specific

• DSVG Breast Implants • DSVG Cardiac ablation • DSVG Cardiac Implantable Electronic Devices • DSVG Coronary stents

Device Specific

Vigilance Guidance (DSVG)

• MDCG 2024-1-1: DSVG 01 on Cardiac ablation • MDCG 2024-1-2: DSVG 02 on Coronary stents • MDCG 2024-1-3: DSVG 03 on Cardiac implantable electronic devices (CIEDs) • MDCG 2024-1-4: DSVG 04 on Breast implants • MDCG 2024-1-5: DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence

• DSVG Inferior vena cava filters • DSVG Insulin Infusion Pumps • DSVG Intraocular lenses • DSVG Joint replacement implants • DSVG Neurostimulators • DSVG Software as a medical device

Vigilance Guidance (DSVG)

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

2024-10-24

24

24

12