Ed Ball, senior associate, RQM+ summarises the requirements of the UK Conformity Assessment certification (UKCA mark) and highlights top priority areas for attention.
As of the 1st of January 2021, the UK has entered the transition period towards its new regulatory regime. As well as achieving compliance for the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device businesses with products on the UK market need to plan for how they will obtain a UK Conformity Assessment certification (UKCA mark). Manufacturers have until the 30th of June 2023 to obtain UKCA marking for their devices. After that point, the CE mark will no longer be recognised in Great Britain (GB).
Over the coming months, manufacturers will have to keep a close eye on the emerging UK regime as it takes shape. This article aims to help manufacturers make sense of the current UK regulatory landscape by providing five steps businesses can immediately start integrating into their planning.
Step 1: Identify data gaps from MDR/IVDR efforts
The UK Medical Devices Regulations (UK MDR) 2002 – which will continue to apply in England, Scotland and Wales until June 2023 – are based on the EU directives for medical devices and in vitro diagnostic medical devices, but it is likely that future UK legislation will come to closely resemble the MDR and IVDR. This means that efforts and resources invested into complying with MDR and IVDR could be repurposed for UKCA marking. Manufacturers should therefore begin by assessing the gaps in data and documentation and plan strategically around these in order to eliminate any unnecessary duplication of activity.
Step 2: Review compliance effort for each product in portfolio
Given the added financial cost of meeting this new compliance requirement, businesses should review their portfolio and the regulatory status of each product and assess the compliance effort required for each device. Manufacturers are advised to build a compliance ‘risk matrix’ of products based on device classification, CE mark status, UK regional sales and level of preparedness. From there, manufacturers must consider whether it makes commercial sense to continue to supply all product classes to the UK. Conversely, they may wish to introduce new products on the UK market based on the findings of this assessment.
Step 3: Source your strategic partners
Businesses outside the UK must source a UK-based Responsible Person (UKRP). In order to register with the Medicines and Healthcare products Regulatory Agency (MHRA), all UKRPs must have a registered place of business in the UK and be identified on the device’s labelling or IFU alongside the UKCA mark. Once a UKRP is appointed, clear communication channels must be established for managing and sharing documentation.
The conformity assessment of certain device classifications for the UKCA mark relies upon UK Approved Bodies rather than EU Notified Bodies. At present, only three UK organisations are acting as Approved Bodies so there is a risk of them becoming quickly overloaded with demand for their services. Manufacturers who require the services of a UK Approved Body are advised to liaise with their EU Notified Body to determine their intentions for the UK market (e.g. plans to become UK Approved Bodies) and/or engage with one of the Approved Bodies currently listed.
Step 4: Get a head start and anticipate delays
While June 2023 may seem a long way away, businesses should consider the time required for their documentation to be updated and reviewed (internally and externally where applicable). With the UK no longer part of the European Union, it is likely that EU-based manufacturers and UK importers will see an increase in administrative tasks relating to importing and exporting medical devices, in turn increasing costs. Practical issues within the supply chain may emerge after June 2023 once the CE mark is longer recognised, so it’s vital that all parties are clear on the implications of any new procedures and controls. Keeping close contact with the relevant regulatory authorities will help businesses stay au fait with the developing situation.
Step 5: Stay abreast of new developments and guidance
We can expect to see further guidance from the MHRA throughout the course of the transition period, as businesses start submitting their UKCA documentation and common pitfalls begin to emerge. It is highly likely that clarifications from the MHRA will be required to help businesses make sense of how requirements should be met. Businesses may be able to avoid any pitfalls in their own submissions by monitoring for updated advice from the MHRA and the UK Approved Bodies.
