This is the year of adaption and adjustment – and the medical device industry is certainly no exception. With fewer than 100 days of the Brexit transition period remaining, there are yet more changes and uncertainties on the horizon. It’s clear that medical device manufacturers will need to respond efficiently to the new regulatory developments, sometimes with very short notice. But while this prospect may seem daunting, as the extent and nature of the changes are difficult to predict, I believe there are reasons to be optimistic.
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What do we know at this stage? On 1 September, the UK Government and MHRA (Medicines and Healthcare Products Regulatory Agency) published guidance on the future of UK medical device regulations. They announced that the EU Medical Device Regulations will not automatically apply throughout the United Kingdom from its official date of application in May 2021. Instead, after the transition period ends on the 31 December 2020, the current regulatory framework will be retained in Great Britain as described in the UK MDR 2002 legislation.
While this clarification is welcome, it is also accompanied by many caveats and new uncertainties. The MHRA has indicated that the UK MDR 2002 will undergo further changes throughout the remainder of 2020. The nature and potential impact of these changes are not yet known. In addition, there are regional differences regarding which regulations will apply across the UK. While Great Britain will retain the UK MDR 2002 legislation, the EU MDR will apply in Northern Ireland from May 2021.
To further demarcate the regional differences, there will be at least one new conformity assessment mark, the UKCA mark, which will be required in Great Britain – but not recognised in the EU – in place of the CE mark from 1 July 2023. Devices on the EU market will still need the CE mark, as will devices to be sold in Northern Ireland. Further, medical device manufacturers will need to register their devices with the MHRA and non-UK-based medical device manufacturers will be required to designate a UK Responsible Person to represent them in the UK.
Pressure on strained resources
It is worth highlighting that Notified Bodies in the UK – to be termed Approved Bodies – who have previously provided conformity assessments for the EU market will no longer be recognised by the EU after the transition period. This will no doubt lead to a rush of medical device manufacturers needing to switch to an EU-based Notified Body if they want to continue keeping their device on the EU market from 1 January 2021. Given the shortage of EU Notified Bodies that have so far been designated under the EU MDR, it is likely the pressure on these strained resources will only increase with the added obligation for manufacturers to transfer their technical documentation and assessments, possibly leading to additional delay.
Any extra waiting time may have significant impact on medical device manufacturers’ ability to keep their devices on the market, or on planned timelines for new or next generation medical devices. Crucially, any changes in registrations and certifications will need to be reflected in device labelling from 1 January 2021.
It’s fair to assume that the to-do list for any medical device manufacturer with a device on the EU and UK markets must look overwhelming at this point. Although manufacturers have been getting ready for the EU MDR since 2017, the ongoing lack of clarity around Common Specifications and low availability of Notified Bodies has led to a situation where a majority of medical device manufacturer are still not fully prepared for the EU MDR, despite the delay until 2021.
Revisited and rearranged
The additional requirements to remain compliant with UK medical device regulations are certainly not alleviating the situation. Existing agreements and relationships with Notified Bodies, Authorised Representatives, Competent Authorities, suppliers, distributors and contract manufacturers may all need to be revisited, renegotiated and rearranged. Manufacturers in and outside Northern Ireland will need to ensure there are plans in place to meet all relevant requirements across the distinct regions. New arrangements to meet additional requirements on labelling, technical documentation and a UK Responsible Person will need to be put in place.
Plans for design and development activities, clinical trials, post-market surveillance and related documentation will require reviewing and amending. Gaps will need to be identified and filled. Any change, minor or major, must be implemented carefully by the manufacturer in order to fully understand and address any knock-on effects on other parts of the business. The long-term regulatory or commercial strategies may no longer make sense or need significant overhaul.
So far this article may sound like a description of dark clouds on the horizon. But as I suggested at the beginning, there are definitely some reasons to look on the bright side. The MHRA has indicated it will ‘take into consideration international standards and global harmonisation in the development of our future system’. At Cambridge Consultants, we understand this to mean that a medical device manufacturer with robust and nimble processes for developing compliant medical devices will be well placed to proactively respond to changes, whatever they may be. Not all manufacturers will fall into this category, for many and diverse reasons.
Perhaps you are a medical device manufacturer who has just recently decided to expand your market to include EU and UK. Or maybe you’re a start-up with limited in-house resources to deal with all the diverse compliance requirements. We have extensive experience, expertise, proven track record and compliant processes to help you navigate the ever-increasing complexities and uncertainties related to placing a medical device on the EU and UK markets. We’ll keep a very close eye on the developing situation and the impact on the medical device sector and continue to provide support and help manufacturers prepare for whatever comes around the next corner. You can be certain of that at least. Please drop me an email you’d like to discuss the topic in more detail.