CE Marking Changes in the UK: highlights and pointers for MedDev manufacturers

On the 1^st August 2023, the UK Government announced that they intend to continue to recognise CE marking across England, Wales and Scotland, indefinitely, for most goods beyond December 2024[1].

The CE marking has long been a symbol of compliance with essential health, safety, and environmental requirements for products sold within the European Economic Area (EEA). Its continued recognition in the UK helps businesses maintain access to the European market and ensures the smooth flow of goods.

This decision has brought relief to many industries, confirming a smoother transition as the UK moves forward independently. However, amidst the news coverage, confusion has arisen, especially in the MedTech sector, as the announcement does not encompass CE-marked medical devices or In-vitro diagnostic devices (IVDs). In this blog, we aim to shed light on the matter and provide clarity on transitional timelines and requirements. 

Medical devices and their unique regulations

The UK Government has made it clear that different rules apply to certain sectors, including medical devices. This means that the announcement of continuing recognition for the CE marking does not automatically extend to CE-marked medical devices.

The details surrounding the transitional timelines for placing CE-marked medical devices and in-vitro diagnostics on the UK market have already been announced when the government released a detailed update on the implementation of the future regulations on July 27, 2023[2].

Understanding the transitional timelines

The Implementation of the Future Regulations[3] extends the acceptance of CE marked medical devices and In-vitro diagnostics on the Great Britain market. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.

Specifically, CE marked medical devices may be placed on the Great Britain markets according to the following timelines:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

In addition, the legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

• self-declared against EU MDR requirements (until 30 June 2030), or
• self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes unclassified devices and reusable surgical instruments.

It also provides that a Class I medical device which has a sterile or measuring function with a valid MDD certificate can be placed on the GB market until 30 June 2028.

To further assist manufacturers and stakeholders in the MedTech industry, the UK Government has provided an infographic outlining the CE-marking transitional timelines.

Those involved in the production and distribution of medical devices need to be aware of the outlined timelines to avoid any disruptions in the supply chain and ensure that their products remain compliant with the new regulations.

Guidance for CE-marked devices with expiring certificates

In addition to the timelines, the UK government has also released comprehensive guidance[4] on the registration of certain medical devices with expiring certificates, aimed at assisting businesses in the MedTech sector during the transition to new regulations. CE certificates with extended validity under the extended EU MDR transitional arrangements (Article 120) are valid for placing devices on the NI and GB markets while EU AIMDD and EU MDD CE marked medical devices are accepted.

This means:

• provided that the conditions for placing a device on the EU market set out in EU MDR Article 120(3c) are met, they are valid for placing a medical device on the Northern Ireland market up until the end of the relevant transition period set out in Article 120(3a)
• devices with valid EU AIMDD and EU MDD certificates can be placed on the GB market up until the expiry of the certificate or 30 June 2028

Manufacturers who wish to rely on a previously expired CE-certificate (that was still valid on 26 May 2021 and expired before 20 March 2023), MHRA requires the manufacturer or their appointed Authorized Representative (UKRP), upload a letter declaring that key conditions for extension of the certificate (under EU MDR Article 120) have been met.

Meanwhile, within this comprehensive guidance, MHRA have also provided six case scenarios which cover the possible circumstances for expiring CE-certificates and the obligations are described in each case. Businesses are urged to proactively plan and execute the registration process within the given timeline to avoid any disruptions in the supply and distribution of medical devices.

While the UK Government’s decision to continue recognizing the CE marking of medical devices and in-vitro diagnostics beyond July 1^st, 2025, is a positive step towards ensuring a smooth transition, it is crucial to understand that this recognition does not automatically extend to CE-marked medical devices. The MedTech sector must pay close attention to the specific regulations and timelines communicated by the relevant departments to avoid misinformation and potential disruptions in the market. As the landscape of regulations evolves, businesses and stakeholders should stay vigilant, seek official updates, and adapt their practices accordingly. By staying informed and proactive, the MedTech industry can navigate the changes with confidence and continue delivering safe and innovative medical devices to patients and healthcare professionals alike.

[1] Gov.uk, UKCA marking conformity assessment and documentation

[2] Gov.uk, Implementation of the Future Regulations

[3] Gov.uk, Implementation of the Future Regulations

[4] Gov.uk, Guidance on registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates