A new marking for medical devices in the UK
It has been in the news for some time now but the UK has left Europe for good. The Brexit has been agreed and implemented. This has of course brought its share of regulatory changes for trade between Europe and the UK. The Healthcare sector is no exception. But what does this mean for medical device suppliers?
A new marking for the UK
For product identification, the GTIN still applies but the UK has decided to create a new marking, the UK Conformity Assessed (UKCA)*. This is a product conformity marking used for medical devices and other goods placed on the market in the UK. It covers most devices that previously required CE marking in the EU.
A UKNI marking (conformity marking for products placed on the market in Northern Ireland) is required in addition to the EU CE marking for devices placed on the market in Northern Ireland by a UK-based manufacturer or by a manufacturers choosing a "UK Notified Body" for mandatory third party assessment. This UKNI marking must be combined with the EU CE marking. Please note that this UKNI marking cannot be used on devices placed on the EU market.
Until 30 June 2023, for most devices, economic operators have the option of affixing the UKCA mark to a device label. From 1 July 2023, the UKCA marking must be affixed to the labels of the device packaging. The UKCA marking can be used in conjunction with the CE marking.
But why is this a problem?
According to GS1's GTIN allocation rules for the Healthcare sector (find the explanatory article here), a change in packaging to add a new certification mark or to remove an existing one that has significance for competent authorities, notified bodies, other economic operators, and/or for the end consumer, therefore requires the allocation of a new GTIN.
However, it should also be noticed that when a certification mark is added to allow for sale in a new country/market, it has no impact on the countries/markets where the product was previously sold - in this case there is no need to assign a new GTIN in the above scenario.
Brand owners are responsible for the internal control of their inventory and any return systems. It is important that these systems, as well as the logistical management of phasing-in and phasing-out, can distinguish between "old" and "new" product. Where this can be achieved effectively by using an alternative identification satisfactory to all trading partners, a new GTIN need not be assigned in this scenario, but the external supply chain should not be affected in terms of expected functionality.
What does GS1 recommend?
To ensure harmonised implementation of the UKCA marking requirements whilst aligning with industry practice, it is not necessary to assign a new GTIN to medical devices supplied to the market in the UK, assuming the addition of the UKCA to an already CE marked product. However, it is essential to ensure that medical devices that have the new conformity marking can be differentiated from those that do not, normally through a new GTIN allocation or other product identification, to ensure patient safety and supply chain management between all trading partners.
GS1 Healthcare's GTIN allocation rules state that "it should be noted that when a certification mark is added to enable sale in a new country/market, it does not impact on the countries/markets where the product was previously sold - in this case a new GTIN does not need to be allocated”. Following Brexit, the UK can be seen in this context as a new market, with new regulations and market specifications.
In case of doubt, as the GS1 General Specification states, regulatory requirements from around the world will always override GS1 standards when applied to healthcare products.
*For a complete description of the UKCA mark requirements for medical devices, please refer to Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002): Part II of the UK MDR 2002 on general medical devices, Part III of the UK MDR 2002 on active implantable medical devices, Part IV of the UK MDR 2002 on in vitro diagnostic medical devices (IVDs).