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Regulation Updates: UKCA vs CE Markings for Medical Devices

Within the EU, CE marking is mandatory for machinery, electrical and electronic equipment, medical devices, personal protective equipment and toys. As such, anyone looking to sell electrical products in the EU will need to test for compliance and affix a CE mark to their product.

CE certification mark

Previously, these standards were uniform across all European Union members, including the United Kingdom. However, this changed due to Brexit. 

CE Marking Timeline Extensions

UKCA marking replaced CE marking on 1 January 2021.  Therefore, most products that previously required CE markings would need to have a UKCA mark in order to be sold on the UK market. 


However, as of August 1st, 2023, in order to give businesses time to adjust, the UK government updated their plan to grant an ongoing recognition of the CE marking for the distribution of a wide range of goods within Great Britain, extending indefinitely beyond December 2024.


The utilization of the UKCA marking is mandatory for individuals or entities involved in the production or handling of products within the subsequent sectors:

Toys Measuring instruments Gas appliances
Pyrotechnics Measuring container bottles Machinery
Recreational craft and personal watercraft Lifts Equipment for use outdoors
Simple pressure vessels Equipment for potentially explosive atmospheres (UKEX) Aerosols
Electromagnetic compatibility Radio equipment Low voltage electrical equipment
Non-automatic weighing instruments Personal protective equipment (PPE) Pressure equipment


For Medical Devices, the current rules is also to accept CE marking, but with a different timeline. 


Regulating Medical Devices in the UK

(updated July 27th, 2023)


ukca banner

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

Some CE marked devices will be accepted in the Great Britain market until 30 June 2030 depending on device type and classification (see below): (Source:

  1. Implementation of Future Regulations
    The UK government is embarking on a journey to implement substantial reforms in the existing regulatory framework for medical devices. The blueprint for this reform was outlined in response to the 2021 consultation on the future regulation of medical devices in the UK. The primary goal is to introduce a phased approach that ensures a proportionate implementation of the future regulatory framework. This approach is designed to bolster system readiness and minimize the risk of supply disruptions for patients in the UK.

    NOTE: The United Kingdom will continue to accept EU certificates for medical devices until June 30, 2030, as per existing legislation. However, additional updates on the regulatory regime for medical devices are expected to come into effect from July 1, 2025. This suggests a transition period for the medical device regulatory landscape in the UK. 

  2. Transitional Arrangements
    To facilitate a smooth transition towards the new regulatory framework, the UK government has put in place legislation that modifies The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). These amendments extend the acceptance of CE marked medical devices on the Great Britain market. This extension aims to support the uninterrupted supply of medical devices to Great Britain and ease the transition to the future regulatory framework.

Key timelines for the acceptance of CE marked medical devices on the Great Britain market:

  • 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 until the sooner of the certificate's expiry or June 30, 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 until the sooner of the certificate's expiry or June 30, 2030.

  • 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 until June 30, 2030.


Certain self-declared CE marked Class I medical devices may continue to be placed on the Great Britain market beyond June 30, 2023, under specific conditions

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