Following the UK’s departure from the European Union and the signing of the EU–UK Trade and Cooperation Agreement, there has been a seismic change in the trading relationship between the UK and the EU single market. While the new arrangements can facilitate tariff-free trade, there are new regulatory hurdles to overcome, and the Northern Ireland protocol creates further complications as it straddles the two regulatory jurisdictions.
Since the implementation of the Medical Device Directive (Council Directive 93/42/EEC) in 1995, medical devices intended for sale in the EU single market have been required to carry the CE mark as an indication of compliance, alongside the identification number of the certifying notified body. Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that from 1 July 2023 all medical devices for sale in Great Britain (England, Scotland, and Wales) will need to carry the new UKCA (UK Conformity Assessed) marking1.
The EU–UK Trade and Cooperation Agreement does not feature mutual recognition of conformity assessments, so products destined for the EU and EEA markets will still need to carry a CE mark. The Northern Ireland protocol also means that medical devices with a UKCA mark cannot be placed on the Northern Ireland market unless also accompanied by a CE or CE UKNI mark.
Post 1 July 2023 conformity marking requirements for medical devices:
Until the deadline of 1 July 2023, the UKCA mark can be voluntarily used and medical device manufacturers now need to consider how they will handle this transition in product labeling. Dual marking is an acceptable approach (CE and UKCA), where country-specific labeling is not required, however, space available on a label will be a consideration, especially as the name and address of the UK Responsible Person will need to be included on labeling alongside the UKCA mark if the medical device is manufactured outside the UK.
It is undeniable that the transition to the UKCA conformity mark will require extensive changes to product labels for medical devices intended for use within Great Britain and Northern Ireland. Manufacturers who are equipped with global labeling systems with mass change capability will be able to scope change almost instantaneously, leveraging the data within the system to identify SKUs by their existing conformity marking and intended market, however, our recent survey revealed that less than 8% of companies have access to such a system.
Medical devices without the correct conformity mark are likely to be delayed in customs and the correct marking will need to be affixed before the product is legally permitted to be released on the market for use. Manufacturers must ensure they have plans in place for this transition to avoid disruption in the supply chain and costly relabeling efforts.