Recent developments in UK regulations for IVDs: implications for EU manufacturers.

Description: UKCA marking came into effect in the UK in January 2021 when the UK left the EU. The UK legislation valid since January 2021 is the Medical Devices Regulations 2002 (SI 618) as amended by the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478). The new transition period until 30 June 2024 allows for the replacement of existing CE certifications with the new UKCA marking, but from 1 July 2024, any IVD manufacturer who puts their product on the market in the EU and the UK will have to comply with the IVDR and UK MDR. In the meantime, much is about to change as MHRA is developing future legislation for medical devices to achieve more harmonization across the industry, and to improve the safety of medical devices while also meeting fast-moving developments and enabling innovation, in conjunction with international regulations.
This presentation will cover the UKCA marking conformity assessment process, and how the transition affects EU manufacturers.

Christèle Perrin- East ( NAMSA) :
The first part of the session will include the latest guidance and interpretation available in this area as implementation of the IVDR and UK MDR 2002 continues, to help manufacturers
• Understand what changes in the regulation are proposed for the UK
• Identify significant areas of difference between the new MHRA Medical Device Regulations and the EU IVDR
• Leverage transitional provisions for CE marked devices

Philippe Auclair ( Abbott) :
The second part of the session will focus on a manufacturer’s view on the opportunities with the UK’s regulatory system
Specifically,
• Access to Innovation and Flexible Routes to Market
• Broadening Use of Electronic Labelling and Instructions for Use
• Leadership in Global Harmonization Efforts
• Regulating Products Without a Medical Intended Purpose

Q&A with audience