Government’s response to consultation on the future regulation of medical devices in the UK: A summary and what it means

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published the consultation outcome as to the future landscape for medical devices and in vitro diagnostics in the UK and importantly what the new requirements might look like under the future UK medical device regulations and what will happen during the transition period.  For the purposes of this review, the future format of the medical device requirements for the UK are simply referred to as the future UK Medical Device Regulations, a terminology, which differentiates the future status from the existing UK 2002 Medical Device Regulations, which gave effect in UK law from the Medical Devices Directive (93/42/EEC), the Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/07/EC).  These are collectively referred to as the medical Device Directives (MDD). What are the main take home messages?

In this article, Medilink’s Head of Innovation and Commercialisation, Patrick Trotter PhD, MBA, assesses the government’s response to the consultation and provides his interpretation of how this will impact the future of the UK regulatory landscape.

What will the future UK Medical Device Regulations look like?

There is a general indication that the future UK medical device regulations are likely to align more closely with the EU Medical Device Regulations (MDR) than the historical MDD, influenced from the overwhelming feedback from 891 responses. Examples of alignment with the MDR include the reclassification of devices without a medical purpose, such as non-prescriptive decorative contact lens or dermal fillers, which will be regulated as medical devices under the future UK Medical Device Regulations and there will be strengthening of post market surveillance (PMS) requirements. Furthermore, there will also be improved traceability, including introducing Unique Device Identification (UDI) and the requirement for manufacturers of certain high risk and implantable devices to provide a  Summary of Safety and Clinical Performance (SSCP) which would be publicly available. Importantly, the government have indicated an intention to align with the General Safety and Performance Requirements (GSPRs) to avoid confusion and divergent requirements.

However, there are some clear   differences from the EU MDR, for example, the government’s response indicates an intention to proceed to utilise both the Medical Device Single Audit Program (MDSAP) and to use Domestic Assurance (i.e., approvals from other countries) as alternative routes to market in the UK, although UK Approved Bodies would be able to reject applications under the Domestic Assurance route if the evidence was not sufficiently robust. The rationale for this is to mitigate the risk of future medical device shortages. One additional interesting development is that the government are considering giving the MHRA more power to grant initial market approval, although it is likely that this will be limited to defined circumstances.

What will happen during the transition period?

Whereas the target date for implementation appears not to have charged (1st July 2023) for companies with products certified before the 1st July the following transitional arrangements are likely to apply.

– For both medical devices and in vitro diagnostics that hold a valid certification/declaration of conformity to the CE standard, issued under the EU MDR (2017/745) or the EU IVDR (2017/746), the government have stated that they wish to establish a transitionary arrangement for these products which will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. Assuming the new regulations come into effect on the 1st July 2023, that means devices placed on the market before 1st July 2023 can remain on the market until 30th June 2028 or until their certificate expires (whatever comes sooner).

– For medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the Medical Devices Directive (93/42/EEC), the Active Implantable Medical Device Directive (AIMDD) (90/385/EEC), or the In Vitro Diagnostic Medical Devices Directive (98/07/EC), the government plan to establish a transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner.

There are caveats to the above, with devices subject to significant changes in design, or intended purpose will be excluded from these provisions and all post market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements.

In reality, this means that for many devices certificates will remain valid for the duration of their certificate, or for three years for MDD, and five years for MDR or IVDD.

What is the impact and recommendations for UK companies?

The government’s response clearly signals an intention for the future UK medical device regulations to be aligned with the EU MDR, and although there are likely to be differences, if you are developing new products or have currently technical files aligned to the medical device directives (MDD) or UK MDR 2002, it would be prudent to develop the technical documentation to the standard of the EU MDR.   This might explain why the government intend to allow longer transition periods for devices holding certificates or declaration of conformity to the MDR, rather than the MDD. This should ultimately reduce the pain and effort involved in future transition to the UK Medical Device Regulations, whenever the new regulations come into force.

The full government response to the consultation can be found here.

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