Lyndon Boyer, QA/RA Consultant, LFH Regulatory, discusses how the new regulatory framework can affect importers in the UK.
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Since the UK officially left the EU, importers in the UK have been subject to a new regulatory framework. Importers must comply with the UKCA marking requirements, which replace the CE marking previously used under EU regulations – although for the time being, medical device CE marking is still accepted. The MHRA (UK Medicines and Healthcare products Regulatory Agency) now oversees the approval and regulation of medical devices in the UK market.
Distributors, placing devices from the EU on the GB market, who are now importers, find themselves dealing with additional obligations. Understanding these obligations is crucial for companies operating in GB to ensure compliance and continued market access. Furthermore, if you are a manufacturer in GB wanting to market and distribute from an entity in the EU, someone needs to take care of the additional importer obligations of Article 13 in the EU Medical Device Regulation.
UK requirements
While the UK MDR 2002 does provide regulatory requirements for manufacturers, authorised representatives, and conformity assessment bodies, it does not specifically outline the obligations of importers. The only obligations clearly outlined are listed on the MHRA website ‘Regulating medical devices in the UK’. This states that the importer is required to inform the relevant manufacturer or UKRP of their intention to import a device. Obligations on storage, transportation, and label checks also apply. The importer’s address does not need to be on the label unless acting as the UKRP.
The consultation on future medical device regulations back in 2021 proposed a list of obligations for importers which include requirements to:
- Keep records for the device for a specified time period.
- Ensure safe storage and transport of devices.
- Ensure devices are appropriately labelled and assigned a UDI.
- Cooperate with the MHRA during investigations of potentially unsafe devices.
- Ensure that the end user does not receive a medical device which has passed its expiry date.
- Inform the manufacturer or the manufacturer’s UKRP that they intend to import the device.
- Have an appropriate Quality Management System.
- Provide their details on the packaging or a document accompanying the device.
69% of respondents supported the introduction of these obligations. Therefore, it is likely that these will be published as part of the new UK Medical Device Regulations expected to be in place in 2025.
Comparing the EU requirements
The introduction of the EU MDR 2017/745, combined with the UK’s departure from the EU, has induced confusion for some. It is important to distinguish the difference between the requirements of each territory.
The EU medical device importer is defined as any natural or legal person established within the Union that places a device from a third country on the Union market. Most of the proposed GB importer obligations align with the EU medical device importer obligations. The EU importer has to carry out checks on the conformity of the device, hold a copy of the Declaration of Conformity, and ensure they are identified on the product, its packaging, or accompanying documentation. However, these rules are listed out in the EU legislation specific to medical devices (EU MDR 2017/745), unlike the UK MDR 2002, making the EU medical device importer’s obligations much clearer.
Manufacturer responsibility
It is important to remember that the legal manufacturer is responsible for the medical device. Therefore, the manufacturer should have an agreement with all economic operators, in writing, that lists out their responsibilities, wherever they are in the world. This puts a safeguard in place to maintain traceability and accountability, which is crucial during any adverse event.