As you are for the moment, but a change of CE-nery is coming…
The UK government has set out further detail of the future regime for medical devices, which will fully apply from 1 July 2025. Most significantly, it intends to extend the acceptance of CE devices on the UK market, so that they can continue to be placed on the market beyond 30 June 2023.
Background
In June 2022, the government produced its response to a consultation led by the Medicines and Healthcare Products Regulatory Agency around proposed changes to the regulatory framework for medical devices, seeking to amend the Medical Devices Regulations 2002 which govern the use of medical devices in the UK. Whilst the corresponding EU regulatory framework was updated by the Medical Devices Regulations 2017/745, these regulations were not applied to the UK following its departure from the EU, meaning the 2002 Regulations are still in force.
In its response to the MHRA consultation, the government indicated that it intended to introduce a ‘world-leading’ regulatory framework that, in places, went further than the EU regime (for instance, having stricter rules where a manufacturer seeks to indicate equivalence with a product already on the market), with the core parts of the new framework to apply from July 2025.
Transitional arrangements
Transitional arrangements
The government has stressed in its response to the consultation that the new framework will be carefully considered and ‘proportionate’, implemented in a methodical and ‘phased’ approach.
To smooth the transition to the new framework and, more pressingly, to address the fact the 2002 Regulations provide that the acceptance of CE marked medical devices will expire on 30 June 2023, the government has announced it intends to introduce transitional arrangements in spring 2023 that will extend the acceptance of CE devices in the UK market.
The table below sets out the proposed transition arrangements for general medical devices (GMDs) and in vitro diagnostic medical devices (IVDs):
| Device | Legislation under which CE certificate has been granted | Device can placed on the UK market until |
|---|---|---|
| GMD | EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) | 30 June 2028 |
| GMD | EU Medical Devices Regulation (EU MDR) | 30 June 2030 |
| IVD | EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) | 30 June 2030 |
| IVD | EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) | 30 June 2030 |
The transitional arrangements also go further:
- Class I medical devices and general IVDs which previously did not require a notified body to assess the device under EU MMD or EU IVDD can only be placed on the UK market where a notified body would be required underEU MDR or EU IVDR (for example, if it is an nclassified device or a surgical instrument Class I device).
- Any custom-made devices that do not comply with EU MDD or EU AIMDD will not be able to be placed in the UK market.
What does this mean in practice?
The transitional arrangements are not unexpected and will codify what the government set out in writing in its response to the MHRA consultation. The practical effect is that the current position will remain unchanged, and the arrangements will allow CE devices to continue to be placed in the UK market.
However, it is worth noting that whilst manufacturers seeking to place CE devices in the UK will be able to renew any certificates that are due to expire, the government has intimated that future arrangements will be introduced meaning it will not be possible to rely on EU MDR or EU IVDR CE certificates that have been renewed after the future UK framework is implemented – i.e., from July 2025 onwards.
The advice to those seeking to continue using CE medical devices is to check the date of expiry for your CE certificate and ensure any renewal application is made prior to July 2025.
For further information or support, please get in touch.
For further information, please contact:
Ambika Pugalia, Hill Dickinson
ambika.pugalia@hilldickinson.com
