The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an extension to the period during which CE-marked medical devices will be accepted in the Great Britain market. The guidance followed the transitional period extensions granted by the European Union earlier this year for legacy EU devices. The time periods set out in the MHRA announcement did not reflect the phasing of the European Union’s extensions and so the position can be confusing. It is important to read the MHRA’s timelines alongside the changed EU law. This article explains the transitional arrangements and includes a handy timetable for both the EU and Great Britain markets.
New Great Britain Medical Device Legislation
Under the current post-Brexit transitional arrangements set out in The Medical Devices Regulations 2002 (UK MDR), European CE-marked devices, including those certified under the old EU Medical Device Directive (EU MDD) and EU In Vitro Device Directive (EU IVDD), may be placed in the Great Britain market until 30 June 2023. New legislation was expected to implement the Great Britain regime at the same time.
In an open letter to the sector in October 2022, the MHRA indicated these periods would be extended, however, the legislation and website guidance was not updated. This triggered an uncertain period for those navigating contradictory MHRA guidance around extensions and the continued use of CE marks and UKCA marks. This uncertainty was compounded following the European Union’s extensions of transitional periods for the new EU Medical Device Regulation (EU MDR).
Great Britain Medical Device Legislative Timeline
As discussed in our prior updates, the EU MDR was not implemented in Great Britain and there have been delays in the implementation of the new medical device framework.
The MHRA has now confirmed that the new Great Britain medical device framework timeline is as follows:
- Legislation introduced: Spring 2023
- Post-market surveillance requirements: mid-2024
- Full application of Great Britain legislation: 1 July 2025
The government’s 2022 consultation response for this framework included proposals that were similar to the new EU medical device frameworks. The consultation also included the following generous transitional provisions from the date of implementation:
- General medical devices: the sooner of certificate expiry or three years
- In vitro diagnostic (IVD) products: the sooner of certificate expiry or five years
These proposed transitional arrangements will not apply if there are significant changes in the design or intended purpose of the device. Additionally, all post-market requirements would continue to apply.
The transitional periods refer to certificate expiry. Due to this wording of the consultation, it is unclear whether self-certified devices will benefit from a three-year transition, as self-certified devices (such as class I medical devices and general IVDs) are not certified by a notified body; instead the manufacturer declares conformity with the regulations. This issue was not addressed in the MHRA’s guidance although it is widely anticipated that the transition periods will apply to these devices. Clarification on this is highly anticipated in upcoming legislation.
Since the consultation, there have been calls for the United Kingdom to also consider reliance routes for placing medical devices in the Great Britain market (e.g., routes that would enable devices certified in other countries, such as the United States, to be placed in the Great Britain market). The government previously announced that it is exploring options for these new routes to market. Last week, the MHRA announced that new regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
Use of European CE Marks
The new guidance also confirms that CE-marked devices will be accepted for placement in the Great Britain market until at least 30 June 2024. The MHRA confirmed that the government intends to put new legislation in place in Spring 2023 to reflect the acceptance of CE-marked medical devices in accordance with the following timelines:
- Medical devices compliant with the EU MDD with a valid declaration and CE marking may be placed in the Great Britain market up until the sooner of expiry of certificate or 30 June 2028.
- IVDs compliant with the EU IVDD with a valid declaration and CE marking may be placed in the Great Britain market up until the sooner of expiry of certificate or 30 June 2030.
- Medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) with a valid declaration and CE marking may be placed in the Great Britain market up until 30 June 2030.
The guidance follows the European Parliament’s March 2023 decision to extend the transitional provisions in the EU MDR so as to allow for an extension of time for compliance with EU MDR until 31 December 2027 or 2028, provided certain conditions are satisfied. For example, the extension periods only apply if there are no significant changes in the design and intended purpose of those devices. To benefit from the extension of the transition period, an agreement must be in place with a notified body before the expiry of the certificate.
Self-certified devices (which are not up classed under the EU MDR) must already comply with the EU MDR or EU IVDR so these devices do not benefit from any transitional period extension.
The time periods set out in the MHRA announcement do not reflect the phased extension periods for legacy EU devices. Thus, it is a confusing picture because the Great Britain time periods must be read together with the EU extensions.
Timetable for EU and Great Britain Markets
The tables below show the transitional time periods for the European Union and Great Britain.
In the European Union, the sell-off period for all medical devices has been removed, meaning that devices placed in the market before or during the transition period and in the supply chain may still be sold or made available.
In the European Union, the sell-off period for all IVDs has been removed, meaning that devices placed in the market before or during the transition period and in the supply chain may still be sold or made available.
* This assumes all conditions under the EU MDR or EU IVDR transitional period extension requirements are and continue to be met.
** This assumes that the certificate expires at the end of the relevant EU MDR or EU IVDR transitional period. If the certificate expires or is invalid prior to that date, then that earlier date will apply.
*** The position with respect to self-certified devices was not clearly specified in legislation but these devices are expected to benefit from a transitional period of three to five years.
What Questions Remain?
Manufacturers keeping pace with developing UK and EU legislation will no doubt be asking whether extending the transitional arrangements will ultimately resolve capacity issues at approved bodies and notified bodies and secure a clear route to market.
The new UK legislation remains highly anticipated and whilst we expect that some detail may be included in the guidance, the industry will no doubt be looking for regulations that provide assurance that the United Kingdom remains a global growth market and an attractive world-class regulatory system.
Clients and investors in the industry will be keen to understand the following questions:
- Do the transitional periods apply to all devices, including self-certified devices?
- What are the sell-off periods for devices placed in the Great Britain market?
- What are the international recognition routes and what is the timing for implementation?
- To what extent do the final legislative proposals mirror those set out in the earlier consultation, including alignment to the EU medical device regime?
- How has the UK government addressed artificial intelligence and software as medical device regulations, including about predetermined change control?