The Medicines & Healthcare products Regulatory Agency (MHRA), which oversees medical devices in the UK, declared on April 28, 2023 that it would continue to accept CE-marked medical devices in Great Britain (England, Scotland, and Wales) after June 30, 2023.
Following the UK’s exit from the EU, under the current transitional rules, medical devices with the CE mark may be sold on the Great Britain market until June 30, 2023. The proposed extension will facilitate the smooth transition to the next regulatory framework for medical devices and ensure the continued safe supply of medical device to Great Britain.
The government is aiming for the core elements of the UK’s future regime for medical devices to make it effective from July 1, 2025. The government wants to propose laws in the future that will implement a significant reform of the country’s current regulatory framework for medical devices.
Extension to Proposed Transitional Arrangements
According to the UK Medical Device Regulations of 2002 (UK MDR), the acceptance of medical devices with a CE mark on the British market will cease on June 30, 2023. However, the MHRA plans to introduce legislation before June 30, 2023, which will stipulate that CE-marked medical devices may only be sold in the United Kingdom under the following conditions:
| Conditions | Deadline |
|---|---|
| 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 mark can be placed on the Great Britain market | Up to the expiry of the CE mark 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 to the expiry of the CE mark certificate or 30 June 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 | Up to 30 June 2030 |
The above mentioned extensions do not apply to…
- Class I medical devices or general IVDs (for which a notified body was not involved in the conformity assessment under EU MDD or EU IVDD)
- Custom-made devices that are in compliance with the EU MDD or EU AIMDD, now cannot sell in Great Britain.
Post Market Surveillance
Additionally, the government is planning to introduce legislation later in 2023 that will enforce increased post-market surveillance obligations prior to the implementation of a more comprehensive future regulatory framework. This illustrates how important it is for the government to increase patient safety as part of any new medical device laws. From mid-2024, these post-market surveillance procedures are anticipated to be in effect.
Reliance on renewed EU MDR/ IVDR CE certificates
In addition, the government stated that it would soon introduce further amendment. As a result, it will no longer be feasible to rely on renewed EU MDR or EU IVDR CE certificates to sell medical devices in Britain once the new regulatory framework for medical devices is in place after July 1, 2025.
Next Steps
The UK Parliament will now review the legislation to carry out the suggested extension, and final approval is anticipated before June 30, 2023.
