In a welcome announcement, the Medicines and Healthcare products Regulatory Agency (MHRA) has stated that certain CE marked medical devices may be placed on the Great Britain market until June 2028 or even June 2030.
The MHRA issued an update at the end of last week confirming the government’s intention to put in place legislation that will extend the standstill period during which CE marked medical devices will continue to be accepted on the Great Britain market.
It was acknowledged that this extension is primarily to help smooth the transition to the planned new regulatory regime and ensure the continued supply of medical devices to users. Amidst widespread concerns about limited capacity of conformity assessment bodies as well as many other pressures on the sector, the MHRA says it has listened to feedback from external stakeholders in making these decisions.
Manufacturers, suppliers and healthcare professionals, not to mention patients should all be relieved by the news. The update is available here.
Future MDR to apply from July 2025
The substantial reform of the current UK regulatory framework for medical devices was outlined in the June 2022 government response to the public consultation on future regulation. In its update, the MHRA state that the government is now aiming for “core aspects” of the future regime for medical devices to apply from 1 July 2025.
Extension for CE marked medical devices
Currently, medical devices with a valid CE mark can be placed on the Great Britain market until 30 June 2023. It was in October 2022 that the MHRA announced its intention to introduce a 12-month extension to the implementation of the future medical device regulations (Future MDR), including the continued acceptance of CE marked devices until 30 June 2024 with transitional arrangements to follow.
Now, the MHRA has confirmed that it intends, before the date of 30 June 2023, to introduce legislation before Parliament which will provide that CE marked medical devices may be placed on the Great Britain market 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 the expiry of the 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 the expiry of the 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.
The above timelines will not include class I medical devices and general IVDs under the Directives (EU MDD or EU IVDD), where the conformity assessment under the relevant Directive, and under the EU MDR or EU IVDR does not involve a notified body. Such devices can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR, i.e., if it is an upclassified device or a Class I reusable surgical instrument device.
Similarly, the timelines will not include custom-made devices that are compliant with the EU MDD or EU AIMDD.
All these proposals are still subject to Parliamentary approval and the MHRA notes there may be changes.
Post market surveillance
By way of further update, the MHRA has given an indication of the timetable that will operate as regards the Future MDR.
As previously planned, the government first of all intends to introduce legislation that will bring into force strengthened post market surveillance requirements, reflecting the government’s priority of improving patient safety as part of the Future MDR. This aspect of the legislation is expected later in 2023, ahead of the wider future regulatory regime, with the new requirements expected to apply from mid-2024.
Reliance on renewed EU MDR/ IVDR CE certificates
The government also noted its intention to make a further amendment in the future. This will provide that, once the future regime for medical devices is in place after 1 July 2025, it will not be possible to rely on EU MDR or EU IVDR CE certificates that are renewed for placing medical devices on the Great Britain market.
EU extension of CE certificates
Following the EU’s decision in March this year to give manufacturers more time to get certain medical devices certified under the EU MDR, the transitional period for higher-risk devices was extended until 31 December 2027 and lower-risk devices until 31 December 2028. It is worth noting the MHRA’s summary of the news here and its implications for the UK.
To provide much-needed clarity for industry, the MHRA have now published this guidance about acceptance of such certificates on the Great Britain market, including 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.
Next steps
Further updates will be forthcoming and much about the Future MDR remains to be clarified. However, the government promises it will ensure a proportionate, phased approach to the implementation of the Future MDR to minimise the risk of supply disruption to UK patients. The regulatory changes will also be accompanied by guidance to support the MedTech sector in the interpretation of the new regulatory requirements.
This confirmation of the extension of the standstill period during which CE marked medical devices can continue to be accepted on the Great Britain market is welcome although stakeholders will want to know that parliamentary approval has been given and that there have been no changes to the MHRA's update.
