CTDA, Specialist Quality & Regulatory Consultancy

The changeable regulatory environment for Medical Devices and In vitro Diagnostic medical devices (IVD) is showing no sign of slowing down as we begin 2025.

The UK Government agency, the Medicines & Healthcare products Regulatory Agency (MHRA) have already provided us with a Roadmap towards the future regulatory framework for medical devices, published on 9 January 2024, recently updated in December 2024.

Given the expectation that these dates are targets, and may change, we can expect the following updates throughout 2025:

January 2025 – Public Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices closes on 05 January 2025.

March 2025 – Publication of new guidance on UK Post-Market Surveillance regulation.

March 2025 – New guidance of use of Exceptional Use Authorisation, including the potential changes in EUA for Covid-19 tests under CTDA.

April 2025 – Potential MHRA Fees change (link to consultation)

April 2025 – Published response on public consultation on UK Post-Market Surveillance regulation.

May 2025 – Certificates issued in accordance with IVD Directive (98/79/EC) Annex VI which shall become void at the latest on 27 May 2025 and can not be used for placing CE marked IVDs on the Great British Market.

June 2025 – Post Market Surveillance Statutory Instrument in force (PMS)

June 2025 – Development of draft guidance on artificial intelligence (AI) development and deployment

Winter 2025 – Statutory Instrument on Pre-Market Requirements

With so much change happening, it has never been so important to engage with your regulatory teams, to understand the impact and implications of the changes and to get ahead of the game. IVDeology work with IVD manufacturers throughout the global industry to Educate, Evaluate and Execute regulatory strategies to Sustain market access.

You can get in touch with IVDeology by booking time with our friendly team here or email i[email protected] – we’d be happy to chat

We also have a series of online webinars that can also support your next steps and understanding of the regulatory landscape, you can check the early 2025 sessions here:

Importance of the role of PRRC (person responsible for regulatory compliance) under MDR and IVDR – 23rd January 2025 The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Training Course

2 day online Introduction to the Invitro Diagnostic Regulation (IVDR) webinar – 5th and 6th February 2025 Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

On the 21^st May 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) launched a consultation on common specification requirements for invitro diagnostic devices. The aim of this consultation is to gauge industry opinion over a 4 week period on introducing common specifications requirements for certain high risk IVD devices placed on the Great Britain (GB) market.

What are common specifications?

Common specifications (CS) set out a minimum set of performance requirements for specific high risk IVDs, principally to ensure a higher level of patient safety. These common specifications will replace the existing ‘Common Technical Specifications’ described under the current Medical Device Regulations (UK MDR 2002).

The consultation asks the following questions:

Should GB common specifications align with the European equivalent, as set out under (EU) 2022/1107
Should monitoring for common specifications be included within a Post Market Performance Follow-up Plan (a key document to describe post market performance data collection)?
Should Covid-19 IVD devices meet a common specification rather than meet the existing CTDA requirements?

The consultation is an opportunity for industry to offer a view on how aligned GB common specifications should be to the EU. In addition, feedback can be given for the potential removal of the much-discussed CTDA process, which could mean that Covid-19 IVD devices will undergo the general process for conformity assessment via UK approved bodies.

You can submit your views and include comments on the consultation here. The consultation is due to end on the 18^th June, so I would encourage any interested parties to submit their views – this is an opportunity to shape the way CS are used in GB.

As a UK provider of quality and regulatory services, IVDeology are proud to engage with the IVD diagnostic keen to support IVD manufacturers on IVD market access. For further information on how we can help, please contact [email protected]

Written by Stuart Angell, MD and Co-founder of IVDeology Ltd and IVDeology UKRP Ltd