Are delays now inevitable?

Edmund Pro tt looks at the delays in MHRA activity which are impacting on the introduction of the new UKCA regulations for medical devices.

The MHRA’s consultation on the new ‘UKCA’ medical devices regime ended in November and we still await the publication of the agency’s consultation response. Deadlines for this publication have come and gone, along with a lot of MHRA sta , and despite an expectation for publication at the end of March, it could now be as late as May before anything is seen. When eventually published the MHRA has confirmed that its consultation response will contain some of the decisions it has taken regarding future policies. There had been some speculation that the response would

Edmund Pro tt is the chief executiveat the BDIA. merely summarise the comments received by the MHRA, but we are hopeful that the response will start to provide some insights to assist members in their planning and preparation, particularly in relation to transitional arrangements and routes to market. This is particularly important given the continued delays in publication and the ever-looming implementation date of the new UKCA regulations of July 1, 2023. However, this date is now has to be very much in doubt.

More delays

Compounding this situation, though the MHRA has hosted the first of its industry and trade association focus group meetings discussing the new guidance that will sit alongside the new UKCA requirements, the next 13 follow up meetings scheduled to take place throughout the year until December have now been delayed a month and are due to commence in early May. This latest delay in proceedings is due to the pre-election period for government communications, known as ‘purdah’. The purpose of the initial meeting was to review the schedule of meetings and subjects to be reviewed. At the request of industry, the MHRA did change its initial proposed schedule in recognition of the very limited time available and the need to address transitional arrangements as a matter of urgency. The further delayed schedule will now inevitably delay things even more and impact on the time that industry has to discuss guidelines that are being written on legislation that we have not yet even seen, which, in itself, is an unusual scenario.

When will we see the regulations?

Meanwhile, the MHRA has o ered some more information on the timing of the regulation itself. We understand that

the text of the legislation itself will first become visible to the public when it is submitted to the World Trade Organisation (WTO). Following submission to the WTO, there will be a 60-day notification period before the text can be laid before parliament. While the MHRA has not indicated when the text will be sent to the WTO, we would assume that this will take place after it has published its o cial consultation response, which continues to be delayed as we described earlier. Combined with allowing time for usual Parliamentary procedure, this could indicate that it could be until late 2022 or early 2023 until the new regulation is passed, leaving only months before we may potentially see CE marks no longer recognised as a route to market for medical devices in Great Britain.

So, are delays inevitable?

Given the series of delays that we have described, it seems that pushing ahead with the introduction of new legislation heralding a massive change in the regulation and route to market for medical devices in GB in the middle next year is becoming a recipe for disaster. Coupled with limited UK Approved Body capacity, introducing the legislation without appropriate transition provisions and dropping recognition of CE marking is looking like more and more of an issue that could impact on device availability and patient safety, alongside very significant challenges for all medical device suppliers. Even within the MHRA there appears to be some growing acceptance that there needs to be a far more ‘realistic’ transition period, with an extended timescale for the continued recognition of CE marked medical devices. This is essential to provide continuity in the marketplace, maintain product choice and availability, protect patient safety and allow manufacturers the time to introduce and implement significant compliance and labelling changes. Therefore, we hope that it just remains to be seen what extensions we see in the transition period, and for how long after 2023 do we see CE marked medical devices permitted on the GB market, one year, two years, or more?

Addressing issues with MHRA device registration

While the full impact of many aspects of the UK’s future regulatory framework for medical devices is yet to be felt, with CE certificates still being accepted for the time being, the industry has been getting to grips with enhanced requirements for device registration since the beginning of 2021.

Over the course of last year, the requirement for all medical devices, not just those of class I as had previously been the case, to be registered with the MHRA was phased in through a series of grace periods. This process has not been without its di culties, and it has represented a significant undertaking for manufacturers.

As well as bringing huge numbers of devices within the scope of the MHRA’s database that had not been included before, this expansion of registration has also seen the introduction of new requirements such as the UK Responsible Person (UKRP) role. At the BDIA’s request the MHRA has provided a list of some of the most common reasons for applications to be rejected. We hope that this information will help manufacturers (or their UK Responsible Person) avoid having their registration application rejected – especially since companies continue to report excessive MHRA response times for applications and queries. Common device registration errors reported by the MHRA:

Letters of designations

a) inconsistent addresses (on what is

indicated on the Appian database as well as Companies House) b) No signatures c) Nothing to indicate an agreement has been made

d) No letter of designation submitted e) UKRPs not established in the UK f) Mandatory tasks not included

Declaration of conformities

a) Declaration of Conformity missing key aspects such as product description b) Wrong Directives indicated c) Declaration of Conformity signed and authorised by the UKRP with no manufacturer, for example no clear evidence that the manufacturer has agreed

Validation of correct UK approved/ Notified body certificate conformity assessment

a) Status of Notified Body inconsistent with Europa Nando website b) Attaching Declaration of Conformity instead of Notified Body certificate c) Using ISO certificates d) Missing one or more required EC certificates as indicated in the

Appian database. In addition, the MHRA has reported a number of falsified EC Certificates of Conformity being submitted and encourages those submitting these documents on behalf of the manufacturer to check their veracity before submitting them.

GMDN clarification (such as validity of code as medical device)

a) Non-medical devices indicated – such as PPE and medicines

b) Review of sub-category products – not listed individually, products listed when should be separate GMDN/ device

c) Bulk upload data – uploaded incorrectly (causes technical problems), as above d) Wrong GMDN chosen – products do not match GMDN description e) Applicants selecting Custom Made (used to register components rather than adhering to the regulatory definition of a custom made device). Meanwhile, the BDIA continues to work to address significant concerns in relation to the device registration process. These include instances of registrations being rejected on the basis that the MHRA disagreed with the classification of a CE-marked medical device, a lack of pragmatism where registrations are rejected for simple administrative errors (resulting in a manufacturer no longer being able to legally place devices on the market) as well as slow email response times and inconsistencies within the registrations team. The BDIA has communicated these concerns to the MHRA’s chief executive, Dame June Raine DBE, alongside fellow medical device associations in a joint letter of the UK MedTech Forum.