Last November the government launched a Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices. The Consultation explored four main areas, including:
International Reliance
Currently, medical devices and in vitro diagnostic devices (IVD) can use the UKCA (UK Conformity Assessed) process to access the UK market either by self-certification for low-risk devices, or by conformity assessment and certification by an approved body.
The proposed international reliance scheme by the Medicines and Healthcare products Regulatory Agency (MHRA) aims to provide swifter market access for devices already approved in comparable regulator countries. This initiative is designed to reduce duplication of assessments, ensuring quicker access to innovative medical devices while maintaining safety and quality standards.
UKCA Marking
To be sold in the UK, medical devices or their sterile packs currently require UKCA marking. New requirements are on the horizon to enhance device traceability.
In Vitro Diagnostic Devices
IVD devices will soon be categorized into one of the four risk classes noted below. Each will have distinct market access requirements. The MHRA is currently seeking views on the requirements to gain market access.
- Class A: Low Individual Risk and Low Public Health Risk
- Class B: Moderate Individual Risk and/or Low Public health Risk
- Class C: High Individual Risk and/or Moderate Public Health Risk
- Class D: High Individual Risk and High Public Health Risk
Assimilated EU Law
The Medical Devices Regulations 2002 transposed relevant EU Directives into domestic law, now known as ‘assimilated’ EU law. Four pieces of assimilated law are due to expire on 26 May 2025. The legislation set to expire includes:
- Commission Decision 2002/364 on the common technical specifications for in vitro diagnostic medical devices.
- Commission Regulation (EU) No 207/2012 on electronic instructions for use (or 'IFU's') of medical devices.
- Regulation (EU) No 722/2012 concerning particular requirements for implantable medical devices and medical devices manufactured using tissues of animal origin.
- Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies.
The UK government has been consulting on the future regulation of medical devices, and the feedback from this consultation will shape the new regulatory framework. The government has indicated that these pieces of assimilated EU law should not expire on 26 May 2025 but should be retained until they are replaced with updated UK legislation.
Retaining EU Law: A Temporary Solution
Concerns arose that allowing the assimilated EU Law to expire could disrupt the regulatory framework and negatively impact patient safety. As a result, the MHRA proposed to remove the revocation date of these four pieces of assimilated EU law so that they continue to apply until updated UK law is in place. This proposal was welcomed with 83% of respondents favouring the status quo. The consensus was that maintaining the current regulatory framework supported patient safety. However, a number of responses noted the need for these regulations to be updated in time.
A draft statutory instrument, the Medical Devices (Amendment) (Great Britain) Regulations 2025, has now been published to remove the revocation dates. The government emphasised that this statutory instrument is only a temporary measure, paving the way for more permanent updates. The medical device industry can expect a series of regulatory changes in 2025, starting with the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, set to take effect on 16 June 2025. You can read about The Medical Devices Post-Market Surveillance Requirements here.
