Module 17 2024

05/12/2024

Areas Delivered 2021 - 2023

Delivered 2021 - 2023

Public consultation

Future core regulations: international recognition stakeholder discussions

.

Transition arrangements for CE- marked devices regulation in place

Consultation response published

Stakeholder awareness sessions for IVDR-NI

Post Market Surveillance (PMS) guidance: stakeholder focus groups

PMS: draft legal text published by World Trade Organization

2021

2022

2023

SaMD guidance published: predetermined change control plans (PCCPs) for developers

3 new Approved Bodies designated: capacity almost doubled

Software as a Medical Device (SaMD) and AI roadmap published

SaMD guidance published: crafting an intended purpose

SaMD guidance published: reporting adverse incidents

Regulations laid in

Parliament for In Vitro Diagnostics in Northern Ireland (IVDR-NI)

Innovative Devices Access Pathway (IDAP) pilot launched

MHRA Roadmap towards the future regulatory framework for medical devices

The Organisation for Professionals in Regulatory Affairs

3

3

Areas Planned 2024 - 2025

The Organisation for Professionals in Regulatory Affairs

4

4

2