Safety First: MHRA Response to UK Medical Device Regulation Consultation

The UK Medicines and Healthcare products Regulatory Agency has published its response.

The Medical Devices Regulations 2002 (UK MDR) regulate medical and in vitro diagnostic devices in Great Britain. However, the UK MDR still refers to the EU Medical Devices Directives (2017/745 (EU MDR) and In Vitro Diagnostic Medical Devices Regulations (2017/746) (EU IVDR).

Following the UK’s departure from the EU, the MHRA will reform the UK MDR to create a new regulatory regime for medical devices. This will include IVDs and medical devices. It will focus on patient safety, transparency, and alignment with international best practices, proportionality, and the development of new technologies.

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The MHRA responded to the Consultation and confirmed its intent to follow the Consultation’s proposals. The updated UK MDR will align with most EU MDR/IVDR elements. However, the updated UK MDR will differ from the EU regime in some aspects and, in other cases, go beyond it. For example, there will be stricter standards regarding relying upon “equivalence, “ allowing medical devices to use data from different clinical investigations. There was some divergence as the UK began to create its regulatory path.

The key takeaways

Scope: The regulation’s scope will be expanded, similar to the EU MDR. Devices currently outside the UK MDR but operate similarly to and pose the same risk profile as a medical device will be caught. Dermal fillers and color contact lenses.

Classification — There will be an update to the classification rules of medical devices. These updates closely align with the EU MDR/EU IVDR and are meant to reflect the changing technology better.

Requirements The UK MDR “Essential Requirements” will be updated to reflect the EU MDR and EU IVDR, “General Safety and Performance Requirements”.

Software: The software will be subject to distinct requirements in accordance with EU requirements. They also follow the International Medical Device Regulators Forum’s (IMDRF), SaMD classification rule for general-purpose medical devices. There will be no artificial intelligence (AIaMD) requirements as a medical device at this stage.

UKCA Mark: Although devices marked CE or UKCA can currently be placed on the marketplace, the UKCA marking will soon become mandatory.

Other routes to market — Both certificates from the Medical Device Single Audit Program (MDSAP) and an abridged assessment based upon approvals from other countries (“Domestic Assurance”) will be used as alternatives to market in the UK.

Manufacturers’ responsibilities: Manufacturers must have adequate financial coverage to cover those affected by adverse medical device events.

Traceability — There will be an increase in the traceability of medical devices, including the requirement for Unique Device Identifiers on each medical device, more detailed record-keeping requirements, and a more extensive registration database.

Not only are the above changes included in the UK MDR updated, but there will be additional requirements for clinical investigations and performance studies as well as Qualified Peoples (UKRPs), economic operators, UK Responsible persons (UKRPs), Qualified Personness, quality management system (QMS), conformity assessment, Approved Bodies and registration of devices.

Next steps and transitions

The MHRA intends that the revised UK MDR will be in force on 1 July 2023.

This response confirms the transitional arrangements in the first place.

• Devices that were UKCA-marked before 1 July 2023 will be able to place on the GB Market until 30 June 2026 for medical devices or 30 June 2028 for IVDs, or until their certificates expire (whichever comes first).
• Devices CE-marked under the EU medical device directive before 1 July 2023 can be placed on GB’s market until 30 June 2026 for medical devices or 30 June 2028 for IVDs, or until their certificate expires.
• CE-marked devices CE under the EU MDR/EU IVDR can be continued to be placed on GB’s market until their certificate expires or 30 June 2028, whichever comes first. This will be effective even if the certification/declaration of conformity is dated after 1 July 2023.

Similar to the EU MDR/EU IVDR transitional arrangements, the UK MDR transitional arrangements are subject to certain conditions. They exclude devices that have undergone significant design changes or were intended for a specific purpose. Devices will still need to meet all post-market requirements starting 1 July 2023.

The next step is to publish draft legislation implementing these changes to meet the 1 July 2023 deadline.