The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November 2021.
Medical devices and in vitro diagnostic medical devices in Great Britain are regulated under the Medical Devices Regulations 2002 (UK MDR). The UK MDR still reflects the historic EU medical devices directives, which have been replaced by the EU Medical Devices Regulation (2017/745) (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR).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 focusing on improved patient safety, transparency, alignment with international best practice, proportionality and facilitating new and emerging technologies.
In the response, the MHRA broadly confirms its intention to proceed with the proposals set out in the Consultation. These include that the updated UK MDR will be aligned with most of the key elements of the EU MDR and IVDR. However, the updated UK MDR will deviate from the EU regime in certain aspects and in some cases go beyond it, for instance in stricter standards for relying on "equivalence" of medical devices to use data from a different clinical investigation. Some divergence was expected as the UK begins to carve its own regulatory path.
Scope: The scope of the regulation will expand, similar to the EU MDR, so that devices which currently fall outside the UK MDR but that operate similarly to and have the risk profile of a medical device are caught, e.g. dermal fillers and colour contact lenses.
Classification: There will be updates to the classification rules for medical devices, that again closely align with the EU MDR and EU IVDR and are intended to better reflect changing technologies.
Requirements: 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 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 mark: While currently both CE and UKCA marked devices can be placed on the market, the UKCA mark will become mandatory.
Alternative routes to market: Both Medical Device Single Audit Program (MDSAP) certificates and an abridged assessment based on approvals from other countries, “Domestic Assurance”, will be utilised as alternative routes to market in the UK.
Manufacturers’ obligations: Manufacturers will be required to have measures in place to provide recompense to those impacted by adverse incidents involving medical devices, such as sufficient financial coverage.
Traceability: There will be improved traceability of medical devices including requiring Unique Device Identifiers (UDIs) on every medical device, more comprehensive record keeping requirements and a new more comprehensive registration database.
The changes in 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 (UKRPs), Qualified Persons, quality management systems (QMS), conformity assessments, Approved Bodies, registration of devices, claims, distance sales and post-market surveillance also to be included.
Next steps and transitions
The MHRA still intends the updated UK MDR to come into force from 1 July 2023.
The response also gives the first confirmation of the intended transitional arrangements:
- For devices that are UKCA marked before 1 July 2023, such products will be able to be placed on the GB market until 30 June 2026 (for medical devices) or 30 June 2028 (for IVDs) or until their certificate expires (whichever is sooner).
- For devices CE marked under the previous EU medical devices directive before 1 July 2023, they can be placed on the GB market until 30 June 2026 (for medical devices) or 30 June 2028 (for IVDs) or until their certificate expires (whichever is sooner).
- Devices CE marked under the EU MDR or EU IVDR may continue to be placed on the GB market until 30 June 2028 or until their certificate expires (whichever is sooner). This will be effective even if the certification/declaration of conformity is dated after 1 July 2023.
Similar to the transitional arrangements under the EU MDR and EU IVDR, the transitional arrangements under the UK MDR are subject to conditions, including that they exclude devices subject to significant changes in design or intended purpose and devices will still be required to comply with all updated post-market requirements from 1 July 2023.
To meet the intended date of 1 July 2023, the next step will be for draft legislation implementing these changes to be published in the coming months.