In January the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) published its Roadmap, setting out the proposed timetable for the future regulatory framework for medical devices. The Roadmap sets out a phased approach for the introduction of the new regime over the next few years, introduced through four Statutory Instruments, with legislation on post market surveillance in 2024 and the core regulations in 2025.

Whilst the details of much of the proposed legislation remain under consideration, the MHRA is committed to working closely with stakeholders (under trusted advisor principles sourced through relevant trade associations) to support the effective implementation of the new legislation and ensure concerns have been addressed and detailed positions are clear before draft legal texts are formally published. Detailed guidance will also be published by the MHRA to support with interpretation of the new regulations.

So, what do we know about the future regulatory framework?

The MHRA is committed to transparency and has published a number of articles/blog posts as well as holding a webinar MHRA MedTech Regulatory Reform Webinar which provide helpful insight into the intentions regarding scope, classification of general medical devices and IVDs, essential requirements and information to be provided with medical devices.

At high level there are a number of key principles which are clearly guiding the reforms to the regulatory framework, including:

· Changes to better reflect advances in technology;

· Improved patient and public safety;

· Increasing international alignment including alignment with international best practise;

· Enhanced transparency of regulatory decision making

In addition to Statutory Instruments (SIs) to give transition provisions a legal footing and one which concerns the application of In Vitro Diagnostic Regulation (IVDR) to Northern Ireland, three further Statutory Instruments are being drafted, covering post market surveillance (the draft legal text of this SI has already been published and sets out requirements for vigilance and the surveillance of products once they are on the market), future core regulations and future enhanced regulations.

What key changes can be expected?

The MHRA has already flagged a number of key changes coming out of its proposed policy on scope, classification and essential requirements for medical devices, based on the government response to the 2021 consultation. The highlights include:

Scope of the Regulations

For general medical devices, there will be an updated definition of ‘Medical Device’ to include a number of additional products. The definition of ‘intended purpose’ will also be updated such that it will be construed objectively and reflected in information supplied with the device, promotional or sales material and technical documentation, thus reducing the risk to patient safety associated with potential misuse.

For in vitro diagnostic (IVDs) 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 and broad definition for software with a view to capturing sufficient breadth of software to protect patients and the public and effectively and proportionately regulate SaMD. It will also include artificial intelligence as a subset. In addition, the MHRA will implement additional pre-market essential requirements for SaMD.

The MHRA has also stated that products with a similar risk profile to medical devices, but which have no intended medical purpose, will not be included in the future core regulations, but will be covered in the future enhancement regulations after further stakeholder engagement.

Classification

The general medical devices classification will align with the EU MDR with the addition of a rule for devices used in the process of in vitro fertilization (IVF) or assisted reproduction technologies (ART). These substance-based devices, that come into direct contact with human embryos before implantation, will be Class III medical devices.

For SaMD that is a general medical device rather than an IVD the MHRA will adopt the risk categorisation in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations .This will result in four tier risk categories adjusted to our current risk categories. For IVDs, classification will move to a classification system based on IMDRF N64FINAL:2021 with UK specific additions for devices monitoring infectious loads of life-threatening infectious diseases 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 adapted to the domestic context (i.e., references to EU laws and provisions will be replaced by the equivalent GB adaptation).

Post Market Surveillance

The post market surveillance SI will strengthen requirements for vigilance and the surveillance of products once they are on the market. The government intends to publish a final version of the SI in June 2024 and guidance will also be published once the final version is available. Contents of the current draft include, amongst others, requirements to implement:

· PMS system and plan

· Preventive and corrective actions

· Initial reporting of serious incidents

· Investigation and final reporting of serious incidents

· Field safety corrective actions (FSCA) and field safety notice (FSN)

· Field safety corrective actions (FSCA) outside GB

· PMS report (self-declared)

· PSURs (all other classes)

What should you do now to prepare for the future changes to the regulatory framework?

As a phased approach is being take to the reforms, it is important to adopt a similar approach when planning for implementation, being mindful of implementation dates of legislation as well as detailed transitional arrangements (not covered here) as they may apply to existing and new devices.

Understanding how the reforms will affect exiting medical devices will be essential, but since significant changes are expected to both the scope and classification of medical devices, it will also be necessary to consider which other products may now fall within the scope of the regulations.

In the absence of definitive legislation and guidance, being familiar with the work currently being undertaken by the MHRA as well as stakeholder discussions as you prepare for the future changes is particularly important. Contact your trade association for further information on the work they are doing to support members interests regarding the reforms.

Finally, if you have any questions on the proposed reform of the UK medical device regulations, or if we can assist you further in regard to your own preparations for the implementation of the new framework, please do get in touch by contacting info@lslawservices.com. We would be very happy to assist.