15 août 2022
On Sunday 26 June the Medicines and Healthcare products Regulatory Agency (MHRA) published the government response (Response) to the consultation on the future regulation of medical devices in the UK. In this article we look at some of the key points of the Response.
The consultation was issued in September 2021 and closed in November, and draft regulations will be published in the next few months. As the new regulations are secondary legislation, they will not be the subject of full parliamentary scrutiny, but instead, if they are laid before the UK parliament at all, they might only be accepted or rejected.
Given that the key rationale for the new regulations is to enhance patient safety and the government is up against its own deadline of 30 June 2023, it is likely that they will be approved. We can therefore expect the new UK medical device laws to be on the statute book in relatively short order after their publication.
The Response to the consultation points to the use of guidance over regulation, so that we might expect to see regulations that are less detailed than the EU regulations are, but which will be supplemented by detailed guidance. This allows the MHRA more flexibility because guidance can be adapted and updated without resorting to legislation.
Below we have given our analysis of some of the key points, in our top 10 highlights.
During the transitional periods CE marked devices both under the directives and the regulations will continue to be accepted, as will UKCA marked devices under 'old' UK regulations. The shortest timelines are for UKCA marked devices and general medical devices whose certificate and/or declaration of conformity (DoC) is/are issued under the EU directives, where certificates and/or DoCs under the UKCA mark must be in place within three years for a device to continue to be marketed.
Interestingly, the Response notes that these timelines will be flexible – perhaps a nod at the UK intending to act more flexibly to meet the needs of the industry, compared with the EU who have been fairly intransigent on timelines.
Note however the transitional provisions relate only to product certificates/DoCs and not to all provisions. One should expect for other provisions, such as those relating to post-market surveillance, economic operators and the UK responsible person to be fully applicable from 1 July 2023.
Unless any applicable certificate expires sooner, the transition times for obtaining a certificate and/or declaration of conformity under new UK regulations for the GB market are as follows:
|Device type||Current certificate and/or declaration of conformity||Transition time from date new regulations are effective|
|General medical device||'Old regulation' UKCA||3 years|
|General medical device||MDD/AIMD||3 years|
|General medical device||MDR||5 years|
|IVD||'Old regulation' UKCA||5 years|
Unsurprisingly many of the proposals have a strong resemblance to concepts in the MDR and IVDR (EU Regulations). This allows manufacturers to reuse the approach already followed for the EU Regulations. Examples of approaches that are the same as the EU Regulations include:
There are some areas of significant departure from the EU regime, or where a UK equivalent means an additional regulatory burden for manufacturers already operating in the EU, most notably in relation to the following:
Every manufacturer and health institution will be required to have a QMS. While health institutions will not require a certificated QMS, manufacturers will have several options for proving that their QMS meets the required standards as part of the certification process.
Note also that the MHRA will have the ability to step in in the event of AB failure (for which there must be one year's notice), and certificates will remain valid for a specified period to allow the manufacturer to obtain certification with another AB.
The MHRA is taking steps to address 'virtual' UKRPs by requiring a physical presence in the UK as they do not accept 'letterbox' UKRPs. The UKRP is also to be liable for defective products. This will mean that the UKRP will have to carry more expensive insurance provision. The UKRP will be required to have a Qualified Person (QP). It is not yet known if the QP will be required to be physically in the UK, or if an EU PRRC based elsewhere might perform this role.
Per the EU IVDR, there must be clinical evidence to support the intended use. Guidance is to be provided on what would count as justification for reliance on other sources of clinical performance data. The government recognises the need for 'international alignment', which could be EU, global or a mix. The SSCP and Post-Market Performance Follow-up (PMPF) is to be updated at least annually with a requirement to regularly review state of the art.
Health institutions will be required to have a QMS, although it will not need to be a certified QMS, and they will need to produce technical documentation and adhere to provisions of adverse incident reporting. The exemption is also to apply only where there are no alternatives available in the market, which is likely to limit its application compared with today's usage, even if health institutions can step up to the higher regulatory burdens imposed.
While the definition of 'software' will be the same as in the EU (where it is defined in guidance rather than law), there are new provisions, such as a specific definition of 'placing on the market' as applicable to SaMD deployed on websites or app stores. It will be clear that SaMD provided via distance sales is subject to UK medical device regulations.
The UK will be following the IMDRF SaMD classification for general medical devices (not IVDs). SaMD will have specific essential requirements, although the essential requirements will closely mirror the applicable EU MDR GSPR. There will also be specific provisions on cyber security and data protection. AI will be regulated via guidance not law. There will be provision for predetermined change control plans (PCCPs) that will help manage changes for software and will be set down in law, although on a voluntary basis at least initially.
Despite responses being equivocal on the point, the MHRA intends to require economic operators to inform the MHRA of issues that will interrupt supply or cause shortages. It will also be a requirement to notify the MHRA of the market status of the device – whether it is premarket, on the market or withdrawn from the market.
particularly where the regulation will affect other government departments. Reserved areas where we might expect some new, as yet undefined, legislation include:
Interested in hearing more about the Medicines and Healthcare products Regulatory Agency (MHRA) Response? Watch our recent webinars:
A breakdown of the key proposals for all devices and their likely implications, including the UK's "new way" for regulating software medical devices.
The impact of the new provisions applicable solely to in vitro diagnostic medical devices.