MEDICAL DEVIC E S
Post-Brexit: medical device compliance
By 30 June 2023, manufacturers will need to have obtained a UK Conformity Assessment certification (UKCA mark) for all their devices, as CE marks will stop being recognised in Great Britain. Ed Ball offers an insight into the post-Brexit implications for medical device compliance.
While focusing their efforts towards EU Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance, manufacturers may have overlooked another pending regulatory challenge. With Brexit comes a whole new set of regulatory requirements that all manufacturers with products on the UK market will need to implement. By 30 June 2023, manufacturers will need to have obtained a UK Conformity Assessment certification (UKCA mark) for all their devices, as CE marks will stop being recognised in Great Britain (England, Scotland and Wales) after that point. With the MDR deadline imminent and the IVDR deadline only a year away, continued availability of medical devices to UK healthcare services will depend on manufacturers keeping pace with multiple regulatory timelines. To provide a starting point and help businesses familiarise themselves with the known UKCA conformity requirements, this article identifies priority
areas for attention and areas where new information may still be emerging.
Mapping out the transition period The transition period towards the new post-Brexit regime officially started on 1 January 2021 and will end in June 2023. During that period, the UK Medical Devices Regulations (UK MDR) 2002 will remain applicable in England, Scotland and Wales. The UK MDR transposes the previous European directives (AIMDD, MDD and IVDD) for medical devices and in vitro diagnostic medical devices into UK law – and must not be confused with the EU MDR. Northern Ireland will follow the EU’s implementation timeline, meaning the EU MDR and IVDR will apply following their respective deadlines.
Repurposing compliance activities Any preparations that have been underway to meet regulatory requirements for the EU
MDR and IVDR will place medical device companies in good stead for this new compliance challenge. By first determining which of their existing MDR/IVDR compliance efforts can be repurposed for UKCA marking, medical device companies can avoid any duplication of efforts. Understanding the overlap between MDR/ IVDR and UKCA requirements will help to identify any gaps in data and documentation. Given that the UK MDR is based on previous European directives, the regulatory burden of achieving compliance for certain products may be reduced and manufacturers may find they have already or nearly met all the requirements. It may be helpful to begin with these products first, making best use of previous compliance efforts and filling in any gaps, thereby minimising unnecessary use of resources.
Assessing compliance effort Each device classification will require varying use of resources – and, therefore, varying financial investment – to achieve compliance. Businesses are therefore advised to assess and compare compliance risk for each device, based on classification, CE mark status, UK regional sales and level of preparedness. This will help them to understand the compliance effort required and to review their product portfolio accordingly. Using this preparatory work, businesses can then decide whether or not to pursue the UKCA mark for all the product categories they currently supply to Great Britain.
Some manufacturers may decide that it does not make commercial sense to invest resources in UKCA marking for certain products, if this investment is considerable. On the other hand, introducing a new product onto the UK market may be an attractive option if existing compliance efforts align with the regulatory requirements for this device. Given the time constraints and
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