What is the latest with the UK Medical Devices Regulations
Statement of policy intent: international recognition of medical devices
The MHRA has released a draft the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
The MHRA are currently recognised CE certification and approvals completed by the European Union (EU) until 30 June 2030, at the latest, to support the transition following EU exit.
Similar to what the UK defined under the IRP scheme a few months ago, it looks like we are moving towards that for medical devices.
The countries that are in the proposed framework are:
Therapeutic Goods Administration (TGA)
Health Canada
National competent authorities in the member states of the EU/ European Economic Area (EEA)
United States of America (USA)
Food and Drug Administration (FDA)
These are referred to as comparable regulator countries (CRCs).
Conditions
To be able to leverage the CRC recognitions, devices must still meet the following criteria:
comply with the relevant legislation in a CRC
have English language labelling and packaging
comply with Great Britain requirements for electronics compatibility (frequency, voltage and plug type), units of measurement, and labelling materials of concern where applicable (for example, for substances which are carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1A or 1B, or could result in sensitisation or an allergic reaction)
have all aspects of the device be in line with the device that is currently authorised in the CRC, including the design, manufacturing process and intended purpose
have a UK responsible person, the name and address of which will be included on the label (this may be via over-labelling, and MHRA will also investigate the ability for digital labelling or digital label solutions)
have a physical unique device identifier (UDI) on parts and labels in compliance with the requirements in the UK Medical Devices Regulations or the CRC
comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations which are expected to come into force in 2024
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Exclusions from international recognition:
exempted in-house devices
custom-made devices
Software as a Medical Device (SaMD) (including Artificial Intelligence as a Medical Device (AIaMD)) products that do not satisfy MHRA intended purpose guidelines
SaMD (including AIaMD) products approved via a route which relies on equivalence to a predicate (US 510(k))
products granted market access in the CRC via a recognition route
Class IIb (non-well established technology (WET)) implantable and III medical devices approved via a route which relies on equivalence to a predicate (US 510(k))
companion diagnostics approved via a route which relies on equivalence to a predicate (US 510(k))
companion diagnostics and combination products containing medicinal substances that are not licensed in the UK
products excluded from the scope of UK MDR 2002, listed in Regulation 3
AI Airlock
In the past, the MHRA have written about the AI Airlock. Coined as “A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).”
But what is this and what does it seek to do?
This is essentially what is called a “sandbox” environment in software.
The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors. The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of Artificial Intelligence as a Medical Device (AIaMD), and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.
The Agency will be trialling and supporting 4-6 virtual or real-world projects through simulation. This will allow to test for a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.
The results will be used to improve MHR Aguidance on AIaMD.
Interesting in getting involved?
AI Airlock will open for applications after the project webinar on 5 June 2024. Applications will be sifted and prioritised against the application criteria and 4-6 will be selected for the pilot project.
If you want any further information on UK Medical Devices Regulations, please feel free to reach out or catch me on LinkedIn.