The UK Government has confirmed the indefinite recognition of CE marking for medical devices and in vitro diagnostic medical devices (IVDs).
This decision provides greater regulatory certainty for the medical device industry, helps ensure the continued supply of medical technologies, and reduces costs and regulatory duplication for companies seeking access to the Great Britain market.
What does this mean for your business, and what should you consider moving forward? Here are the key points you need to know.
Key Takeaways
- Indefinite recognition: CE-marked medical devices and IVDs that comply with the applicable EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) can continue to access the Great Britain market under the relevant arrangements.
- Continuity of supply: The decision supports the continued availability of medical and diagnostic technologies for healthcare professionals and patients.
- Reduced regulatory burden: Companies can benefit from less regulatory duplication and lower administrative costs when placing eligible products on the Great Britain market.
What Is Changing?
Greater Regulatory Certainty
The indefinite recognition of CE marking removes the uncertainty associated with the previous transition deadlines for mandatory UKCA marking. This provides manufacturers with greater long-term clarity when planning their regulatory strategies for the Great Britain market.
Simplified Market Access
Eligible medical devices and IVDs can continue to be placed on the Great Britain market using CE marking, in accordance with the applicable regulatory requirements, without the need to duplicate conformity assessments solely to obtain UKCA marking.
What Remains Unchanged?
Although this decision simplifies market access, manufacturers must continue to meet the applicable UK regulatory requirements.
- MHRA oversight: The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to oversee the safety and performance of medical devices, including applicable post-market surveillance and vigilance obligations.
- UK Responsible Person (UKRP): Manufacturers established outside Great Britain must continue to appoint a UK Responsible Person where required under the applicable regulations.
How Can ASPHALION Support Your Business?
At ASPHALION, we help medical device and IVD manufacturers navigate the evolving regulatory landscape and maintain compliance in the UK and international markets.
Our services include:
- Global and UK regulatory strategy: Defining and adapting your regulatory strategy to support market access and ongoing compliance.
- Post-market surveillance (PMS): Supporting the implementation and management of vigilance and post-market surveillance activities.
- UK Responsible Person (UKRP) services: Acting as your official UK representative, where applicable, to support compliance with UK regulatory requirements.
- Technical documentation and labelling: Reviewing and adapting technical documentation and product labelling to meet applicable regulatory requirements.
Read the Official Announcement
For further details on the UK Government’s decision and its implications for medical device and IVD manufacturers, read the official announcement.
Need Support with UK Medical Device Regulations?
The indefinite recognition of CE marking offers manufacturers greater certainty and flexibility when planning their access to the Great Britain market. However, understanding how these changes apply to your products and regulatory obligations remains essential.
Contact ASPHALION to find out how our regulatory experts can help your business maintain compliance and navigate UK market access requirements: [email protected]
