Medical devices and in vitro diagnostic medical devices in Britain are regulated by the Medical Devices Regulations 2002 (UK MDR). The UK MDR still reflects the historic EU Medical Device Directives, which have been replaced by the EU Medical Devices Regulation (2017/745) (EU MDR) and the Diagnostic Medical Devices Regulation in vitro (2017/746) (EU IVDR).
The MHRA intends to reform the UK MDR following the UK’s exit from the EU to create an updated regulatory regime for medical devices and IVDs focused on improving patient safety, transparency, alignment with international best practice, proportionality and facilitation of new and emerging technologies.
In the response, the MHRA broadly confirms its intention to pursue the proposals set out in the consultation. These include that the updated UK MDR will be aligned with most key elements of the EU MDR and IVDR. However, the updated UK MDR will deviate from the EU regime in some respects and in some cases go beyond, for example in stricter standards to rely on “equivalence” of devices physicians to use data from a different clinical investigation. Some divergence was expected as the UK begins to chart its own regulatory course.
Key points to remember
Scope: The scope of the regulation will expand, similar to the EU MDR, so that devices which do not currently fall under the UK MDR but which operate in a similar way and have the profile of risk of a medical device are taken into account, for example dermal fillers and colored contact lenses.
Classification: There will be updates to the classification rules for medical devices, which again align closely with the EU MDR and EU IVDR and are intended to better reflect evolving technologies.
Terms: The current UK MDR “Essential Requirements” will be updated to broadly reflect the EU MDR and EU IVDR “General Safety and Performance Requirements”.
Software: Software will be defined and subject to separate requirements broadly in line with EU requirements, and will follow the International Medical Device Regulators Forum (IMDRF) SaMD classification rule for general medical devices. No specific requirements for artificial intelligence as a medical device (AIaMD) will be introduced at this stage.
UKCA brand: While currently CE and UKCA marked devices can be placed on the market, the UKCA mark will become mandatory.
Alternative routes to market: Medical Device Single Audit Scheme (MDSAP) certificates and an abbreviated assessment based on approvals from other countries, “Domestic Assurance”, will be used as alternative routes to market in the UK.
Obligations of manufacturers: Manufacturers will be required to put in place measures to compensate those affected by adverse incidents involving medical devices, such as sufficient financial coverage.
Traceability: Traceability of medical devices will be improved, including requiring unique device identifiers (UDIs) on each medical device, more comprehensive record-keeping requirements, and a new, more comprehensive registration database.
Changes to the updated UK MDR are not limited to the above, with additional requirements relating to clinical investigations and performance studies, economic operators, UK responsible persons (UKRP), qualified persons, systems (QMS), conformity assessments, approved bodies, device registration, complaints, distance sales and post-market surveillance should also be included.
Next steps and transitions
The MHRA still intends the updated UK MDR to come into force on July 1, 2023.
The response also gives the first confirmation of the planned transitional arrangements:
- For devices marked UKCA before July 1, 2023, these products may be placed on the UK market until June 30, 2026 (for medical devices) or June 30, 2028 (for IVDs) or until the expiry of their certificate (whichever comes first).
- For devices CE marked under the previous EU Medical Device Directive before July 1, 2023, they can be placed on the UK market until June 30, 2026 (for medical devices) or June 30, 2028 (for IVDs). ) or until their certificate expires (whichever comes first).
- Devices that are CE marked under the EU MDR or EU IVDR can continue to be placed on the UK market until 30 June 2028 or until their certificate expires (depending on the first eventuality). This will be effective even if the certification/declaration of conformity is after July 1, 2023.
Like the transitional provisions under the EU MDR and EU IVDR, the transitional provisions under the UK MDR are subject to conditions, including that they exclude devices subject to significant design changes or destination and devices will still need to comply with all updated post-market requirements from July 1, 2023.
To meet the planned date of July 1, 2023, the next step will be to publish a bill implementing these changes in the coming months.