Update from MHRA on UK MedTech Regulatory Reform

By Karen Hill

The UK medical device regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain (GB). The webinar was presented by MHRA staff (Eve Hutchinson, Clare Thompson, Joseph Burt, Paul Campbell, Jenny Keating and Cristina Santirso-Margaretto) and provided an update on the draft policy on scope, classification and essential requirements for medical devices, based on the government response to the 2021 consultation.

The webinar was followed by an extensive Q&A session.

Synopsis on webinar

The MHRA highlighted that the purpose of the future regulatory framework was “to deliver a robust, leading regulatory framework for medical devices in the UK that prioritizes patient and public safety”, which “enhanced transparency of regulatory decision making” and provided “closer alignment with international best practice”.

Three Statutory Instruments (SI) are currently being drafted, covering Post Market Surveillance, Future Core Regulation and Future Enhanced Regulation.

While the updates provided were not entirely new, the key topics from each session are summarized.  

Scope of the Regulations

• The scope is updated to account for advances in the field, improve patient safety and increase international alignment.
• For general medical devices, new definitions will be provided for “medical device” and “intended purpose” to provide clarity for device users on how and when a device can be used and to reduce risks to patient safety associated with potential misuse.
• For in vitro diagnostic (IVD) devices, software, companion diagnostics and genetic testing will be included in the scope, as will IVDs providing information about a physical or mental impairment.
• Software as a medical device (SaMD) will be included with a new definition introduced and additional pre-market essential requirements implemented. NOTE: THE newly introduced definition for SaMD will be sufficiently broad to allow for flexibility of qualification and will include Artificial Intelligence (AI) as a subset.

It is interesting to note that, in a deviation from the EU Medical Devices Regulation (MDR 2017/745),  products without a medical purpose will not be included in the Future Core regulation but are instead expected to be covered within the Future Enhancements regulation, following further stakeholder engagement.

Classification

• The general medical devices classification will align to the MDR, with the addition of a rule for devices used in the process of in vitro fertilization (IVF) or assisted reproduction technologies (ART), where these substance-based devices, that come into direct contact with human embryos before implantation, will be Class III medical devices.
• For SaMD that are general medical devices and not IVDs, the MHRA will adopt the risk categorization in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations for classification, resulting in the four-tier risk categories (I-IV) aligning with risk classifications I-III, as per Rule 11 of the MDR.
• For IVDs, classification will move to a risk-based classification system based on IMDRF N64FINAL:2021, providing close alignment to the MDR, with only minor modifications. Also, there will be UK-specific additions for devices monitoring infectious loads of life-threatening infectious diseases, such as Ebola virus (Class D), and devices with the intended purpose of screening, detecting or diagnosing neurodegenerative or cardiovascular diseases such as dementia or stroke (Class C).

Essential Requirements

Essential Requirements will be aligned with the General Safety and Performance Requirements (GSPRs) in the MDR and EU In Vitro Diagnostic Devices Regulation (IVDR 2017/746) but will be tailored to the domestic context (i.e., references to EU laws and provisions will be replaced by the equivalent GB adaptation).

Concluding remarks

In terms of timelines, while no definitive dates were discussed, reference was made to the roadmap published earlier this year, which provides an overview of the planned activities.  

It was also stated that the MHRA has no intent to delay implementation of future regulations. It was emphasized that certain actions incorporated in the roadmap are dependent on other priorities outside the MHRA’s control. Furthermore, the upcoming UK General Election, due to take place before January 28, 2025, may also affect the current timelines.

Interestingly, no mention was made of being able to leverage regulatory authorizations from other countries/jurisdictions, as has previously been alluded to.