The world of medical device regulation has undergone unprecedented change in recent years. The impact of Brexit has added to this load, as manufacturers will need to allocate time and resources to negotiate this new compliance challenge, advises Ed Ball, Senior Associate, RQM+
In addition to efforts relating to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), businesses will now also need to comply with post-Brexit regulatory requirements if they wish to continue placing products on the UK market.
To make this process as smooth as possible, this article provides some practical steps to ensure timely compliance.
To comply with the emerging UK regulation, manufacturers will need to obtain a UK Conformity Assessment Certificate (UKCA mark) for all their devices before 30 June 2023.
This “standstill” period of two and half years — beginning on 1 January 2021 — gives businesses the chance to get their ducks in a row before the CE mark ceases to be recognised in Great Britain (GB).
This standstill period is the same for medical devices that are subject to multiple regulations (including PPE, machinery, etc.) regardless of the equivalent standstill period for other regulations (such as the Machinery Directive 2006/42/EC).
In the meantime, the UK Medical Devices Regulations (UK MDR) 2002 will continue to apply across England, Scotland and Wales. Northern Ireland will follow the EU’s implementation timeline for the MDR and IVDR (set to come into place in May 2021 and 2022 respectively). During the transition period, products can access the UK market with either a CE mark or a UKCA mark.
Although future UK legislation is likely to closely resemble the EU MDR and IVDR, the UK MDR is currently based on the outgoing European directives.
Given that the directives were less demanding (in terms of clinical data and post-market surveillance activities) than the incoming MDR and IVDR, it is likely that manufacturers will already have much of the required data and documentation to attain their UKCA mark.
This means that any resources that have been invested into meeting the EU MDR/IVDR can be repurposed. Given the overlap between both systems, planning will be essential to avoid carrying out the same activities twice.
In light of the financial cost of preparing to obtain a UKCA mark, businesses should consider the commercial value of achieving compliance for each product within their portfolio before they begin.
Assessing the regulatory status of each product and the compliance effort needed to meet the UK requirements is a good first step to determine which products to continue supplying to the UK.
From there, manufacturers can map out their products based on device classification, CE mark status, UK regional sales and level of preparedness — and determine which products to prioritise.
Likewise, they may want to consider introducing new products to the UK based on the findings of this exercise. Another consideration when evaluating the product portfolio is the increase in administrative tasks relating to importing and exporting medical devices, and any practical issues in the supply chain that may emerge after June 2023 as a result of the CE mark losing its validity.
To obtain a UKCA mark for certain device classifications, businesses will need to use a UK Approved Body. These will replace the EU Notified Bodies within the conformity assessment process.
Given that only three organisations are currently offering this service in the UK, there may be some delay in getting documentation reviewed and approved. Businesses are advised to get an early start and engage with an Approved Body as soon as possible, or alternatively speak to your existing Notified Body to see if they have plans to become a UK Approved Body.
If manufacturers are not UK-based, they will also have to source a UK-based Responsible Person (UKRP) — equivalent to the EU Authorised Representative — who can register their devices for them.
All devices placed on the UK market must be registered with the MHRA, with the first grace period ending on 30 April 2021 (for Class III and Class IIb implantable devices, all active implantable medical devices and IVD List A devices).
For Class IIb and Class IIa devices, registration will close on 31 August, and IVD List B products and Self-Test IVDs can be registered up until 1 September. In parallel, UK businesses will still need an EU-based Authorised Representative if they wish to continue to access EU markets.
The industry is expecting the MHRA to provide new guidance during the coming months. As UK Approved Bodies begin to receive documentation submissions, common pitfalls are likely to emerge.
As implementation of the EU MDR and IVDR has revealed, further clarification is often required for manufacturers to steer their compliance effort in the right direction.
Any new guidance released by the MHRA and UK Approved Bodies will offer useful advice that can be used to inform the application process. Manufacturers are therefore advised to stay attentive to any updated advice that can help them to prepare for the upcoming deadline.