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Published 2 noviembre 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a decision to introduce a 12-month extension before the implementation of the UK’s new Medical Device Regulations.
With the government still to produce draft legislation, the aim now is to bring the new regulations into force by July 2024. The initial deadline of July 2023 for implementation was fast approaching and looked impossible to achieve. Manufacturers would have been placed under immense pressure and the supply of products to patients could have been threatened. This news is welcome for the MedTech sector and many considered such a delay was inevitable.
The decision is available to view here.
The Context of the Reforms
Following the UK’s exit from the European Union, this was always billed as a unique chance to make substantial reforms to the current UK regulatory framework. The medical device landscape had transformed in its scope, range of products and their complexity since the original EU Directives were drafted nearly three decades ago. The EU has now introduced far-reaching changes via new medical device and IVD regulations that haven’t take effect in the UK. The response to the Covid-19 pandemic has shown that long-established procedures can be safely but radically adapted when required. All these factors made the time right for reform.
This has been seen as an opportunity for the MHRA to improve patient safety and safeguard public health by enabling access to a high-quality supply of medical devices subject to appropriate regulatory oversight. It is also a chance for the MHRA to establish itself as a leading global regulator in this new era. A more difficult but necessary goal is to build the standing of the UKCA mark.
The Revised Timetable
With such a broad canvass, meaningful reform on this scale needs time in order to develop the legislation, take on board feedback and for all the stakeholders to prepare for changes in a timely manner.
Whereas the current UK Medical Device Regulations 2002 state that the acceptance of CE marked medical devices on the Great Britain market ends on 30 June 2023, the MHRA’s announcement sets out the regulator's intention to extend the standstill period during which manufacturers can continue to place CE marked devices on the GB market after 1 July 2023.
From July 2024, according to the MHRA, the planned transitional arrangements, set out in the June 2022 government response to the consultation on the future regulation of medical devices, will apply from when the new regulations come into force for CE and UKCA marked devices placed on the GB market.
This should mean that products which already have conformity markings, either UKCA or CE, can remain on the market for a period of 3 to 5 years after the regulations come into force, depending on the device and the rules under which the existing conformity mark was given. This should see extensions of time until 2027 and 2029 for these categories of product, although the caveats previously stated by the MHRA are expected to continue to apply with devices that are subject to significant changes in design or intended purpose being excluded from these provisions; and all post-market requirements needing to be met by products which benefit from the transitionary arrangements.
After July 2024, it is understood that new devices placed on the market will need to be UKCA marked. Until the end of June 2024, manufacturers can do so under the current UK Medical Device Regulations.
In terms of next steps, the government intends to introduce legislation by Spring 2023 that will bring into force these transitional arrangements. Post-market surveillance requirements, as previously outlined in the June 2022 government response, will be introduced ahead of the wider future regulatory regime, in order to prioritise patient safety.
The MHRA is required to notify the World Trade Organisation (WTO) of the draft regulations and give at least 60 days for comment prior to the regulations being laid in Parliament so there will be an opportunity for stakeholders to review and provide comments on the draft legislation before it comes into force.
The MHRA has stated that the legislation will be accompanied by guidance to help with the interpretation of the new regulations. A series of workshops will also be run, commencing this year, to help refine the MHRA’s thinking and support the implementation of the new regime.
Conclusion – wisely and slow?
Reform of such an important and broad sector was never going to be without its challenges. Preventing avoidable disruption to patient supplies was a priority and will be a relief to manufacturers, healthcare providers and patients.
Continued recognition of the CE mark for an extended period was an obvious and welcome measure but the additional year will go by very quickly. It is clear that work to finalise the regulations is ongoing and the many who will be affected by the new legislation want more detail and certainty as quickly as possible.
The timetable between now and July 2024 is going to be busy with workshops promised, draft regulations to review, a chance to comment, guidance to take on board and change processes to be implemented. Might there be further updates to the timetable from the MHRA? While the state of uncertainty in the sector is far from ideal, it is to be hoped that a realistic stance will be taken if required to ensure the safety and continuity of supply of medical devices.
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