Medical Devices — Brexit
The United Kingdom formally left the European Union on 31st January 2020. Following the end of the transitional period, the Withdrawal Agreement – and the Protocol on Northern Ireland – was implemented on 1st January 2021. While Brexit and the Withdrawal Agreement will entail changes for economic operators, the HPRA has worked with various stakeholder groups over the last number of years to ensure preparedness for the impact of Brexit and the continued supply of medical devices to the Republic of Ireland. Some of the key changes are outlined below.
Key Changes for Stakeholders
All UK-based notified bodies (NBs) have been removed from the NANDO website. Devices requiring certification by a NB must be assessed by an EU-27 NB in order to continue to be legally placed on the EU market.
The CE mark and EU NB number (if applicable) should be clearly visible on the device label and should not be obscured by regulatory information required by another jurisdiction (e.g. the UKCA mark).
All manufacturers located in Great Britain that place devices on the EU market, must have a European authorised representative established and located within the EU-27. The authorised representative should be clearly identifiable on the device labelling.
In accordance with the Northern Ireland Protocol, legal manufacturers and authorised representatives may be established in Northern Ireland.
Economic operators based in the UK (including Northern Ireland) should continue to register with the MHRA as their National Competent Authority. Registration with the HPRA is only required for economic operators based in the Republic of Ireland.
Economic operators, such as distributors, should be aware that if sourcing medical devices from UK manufacturers or distributors (excluding Northern Ireland), they may take on the role of an EU-27 importer and the responsibilities incumbent upon an importer as per Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2019/1020 on market surveillance and compliance of products.
Devices transiting through the UK en route to Ireland (in accordance with Revenue’s transit provisions) from another EU-27 Member State are not considered imported devices within the meaning of medical devices legislation, provided the legal/financial transaction is between two entities both located in the EU-27 (or Northern Ireland).
Brexit Information and Resources
There are a number of resources and communications available to highlight the resulting changes for economic operators in the supply chain. While Brexit readiness has predominantly focused on its immediate onset and consequences, the HPRA is encouraging stakeholders to plan for the medium- and long-term implications of Brexit. The HPRA continues to work closely with the MHRA on a bilateral basis for operational cooperation. Any concerns or queries related to Brexit and medical devices should be communicated through the HPRA contact details below. For further information on requirements arising for economic operators as a result of the Medical Device Regulation (MDR), which will become fully applicable on 26 May 2021, please see our EUDR webpage.
HPRA Summary of Regulatory Requirements
Brexit: Medical Devices Planning
This HPRA presentation summarises the regulatory requirements for economic operators impacted by Brexit and addresses issues such as Device Certificates, Labelling and Authorised Representative requirements. These requirements are applicable since 1 January 2021 when EU legislation ceased to apply to the UK.
Northern Ireland Protocol: Impact on Medical Devices
In accordance with the Withdrawal Agreement, the Northern Ireland Protocol applies from 1 January 2021. Under this Protocol, EU legislation including medical devices legislation will continue to apply in Northern Ireland only. This HPRA presentation summarises the key considerations of economic operators, including the potential impact on Irish distributors.
The HPRA has highlighted some recent guidance from Revenue on customs delays for medical devices here, however detailed guidance is available from Revenue’s website. Delays in customs clearance may occur where no advance information (or incorrect information) has been provided by the importer or their agent, where the consignment is part of a mixed load, or where the importer/agent has insufficient funds in their trader account to pay any customs duty and/or VAT. The submission of all information in advance of the departure of the consignment is key to ensuring the clearance of the medical devices on arrival in Ireland.
EU Commission communication on readiness at the end of the transition period between the EU and UK 2020
EU Commission Notice to Stakeholders March 2020
EU Commission Q&A
EU Commission Notice to Stakeholders January 2018
EU Commission communication to stakeholders September 2019
The HPRA encourages any patients, healthcare providers, notified bodies, distributors, importers, manufacturers or their authorised representatives to contact us with specific questions or concerns about medical devices supply or other device issues in the context of Brexit.
Phone: Call HPRA reception on +353-1-6764971 and ask to be connected to the Medical Devices department.