ABHI Membership

Key Insights from MHRA's HealthTech Regulation Webinar

Following the publication of the MHRA Regulatory Roadmap and Dr Laura Squire's subsequent MedRegs blog, this week saw the Agency host a webinar on the future medical device regulatory regime.

First and foremost, this was a great opportunity to meet the team responsible for putting together regulatory policy that will form the new UK regulatory framework for HealthTech, and for many attending the webinar, this may have been the first time to put faces to names. We will not get a copy of the slides, but the MHRA has promised to publish a copy of the recording, so if you did not catch the webinar on Tuesday, there will be another chance to see the MHRA team in action.

The webinar covered the content of the planned regulations for bringing medical devices, software and in vitro diagnostics onto the UK market. The webinar was not intended to cover international recognition or post market surveillance.

There will be three sets of regulations to be published as statutory instruments (SIs) following on from the Medicines and Medical Devices Act 2021. They are:

1. Post market surveillance regulations covering requirements for safety monitoring of devices in use.
2. Future core regulations covering the core requirements.
3. Future enhancement regulations covering any additional requirements not covered by the core regulations including fees and offences.

We have already seen a draft of MHRA’s post market legislation when it was notified to WTO last year. We are now expecting to see this SI come through an affirmative parliamentary process (i.e. the legislation will need positive approval by parliament). The core regulations have not yet been drafted and we will not see the final draft until notified to WTO. In the meantime, the MHRA is engaging with stakeholders on different parts of the planned legislation, and this week’s webinar covered the scope, classification and essential requirements in the core regulations.

This includes new definitions of 'medical device' and 'intended purpose' to bring them more into alignment with international principles of regulation as set out by the International Medical Device Regulators Forum (IMDRF). There are also new definitions of in vitro diagnostic medical device and software as a medical device (SaMD).

There was a nod to the future enhancement regulation which the MHRA say will include products without a medical intended purpose (also known as 'annex XVI products' in the EU MDR). 

We also saw a glimpse of the new UK classification for invasive and non-invasive devices with special rules for devices containing nanomaterials, substance-based devices and SaMD. For SaMD, UK risk classification will mirror IMDRF categories.

As promised in the 2021 consultation, the classification rules for IVDs will align with IMDRF principles. They should be familiar to anyone who knows the EU IVDR classification system which is also broadly aligned with IMDRF. Some UK-specific principles were highlighted in the MHRA webinar:

• The principles of public health risk and individual risk were explicitly described.
• Wellness products will not be brought into the UK regulations.
• Companion diagnostics, therapeutic drug monitoring and IVDs used with immunotherapies will be included.
• Wearable technologies can be IVDs if they take and analyse a sample from the wearer for a medical purpose.
• ‘In house’ tests will be covered by the UK regulations.

UK essential requirements (ER) will align with the EU MDR and IVDR General Safety and Performance Requirements (GSPR), although references to EU legislation in the GSPR will obviously need to be replaced with references to UK legislation.

The MHRA then focussed on the requirements for information to be provided with devices. Where multiple devices are supplied to the same user or location, then it may be possible to agree on a single copy. Electronic instructions for use may be able replace paper instructions in some circumstances.

There will also be requirements for instructions around:

• Format.
• Usability.
• Storage and shelf life.
• Methodology and performance.
• Device traceability.
• Incident reporting.

There will be additional requirements for the label or instructions to include:

(For non IVD medical devices)

• Clinical benefits.
• Implantable device traceability.
• Biosafety information (e.g. CMR substances).

(For IVDs)

• Intended use (self test etc).
• Metrological traceability.
• Device performance.

Early feedback from members who were able to attend suggests that this webinar was a worthwhile step in the right direction for the MHRA. There was, as you can imagine, much more detail in the webinar than I have been able to summarise here, so I would encourage you to watch the recording of the session when it becomes available.