Medical Devices — Brexit
Two new Regulations on medical devices (MDR) and in-vitro diagnostics (IVDR) entered into force in May 2017 following publication in the Official Journal of the European Union. The MDR originally provided for a three-year transition period, however, due to the global outbreak of COVID-19, full application of the MDR has been extended and will be fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period. Undoubtedly, the UK’s exit from the EU will have a significant impact on the implementation of the legislation as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are significant contributors to the EU medical devices system in helping to shape policy and develop guidance. However, the HPRA and the EU network recognise the importance of addressing a decreased role for MHRA.
The HPRA has worked and will continue to work closely with the MHRA on a bilateral basis for operational cooperation and also in consistency in approach/policy to medical device regulation. It is anticipated that, at least in the short and medium term, the UK will adopt a very similar system for medical device regulation as that outlined in the new EU Regulations. If the UK exit results in a trade deal similar to that maintained with Switzerland or Norway, then it is likely that the regulatory systems will have to remain very similar. If the UK exit results in a trade deal more similar to the Australian relationship with EU, then more variability may be expected in time.
From a practical perspective, a withdrawal or diminished role for the UK’s MHRA not only has consequences on leadership and policy development but also on key operational activities like the joint assessment of notified bodies. The HPRA is promoting discussions to try to identify and find solutions to these challenges to ensure that our regulatory objectives are met, such as ensuring sufficient numbers of notified bodies are designated at EU level in time for the new Regulations.
Are your devices certified by a UK notified body?
Medical devices certified by a Notified Body (NB) and placed on the EU market after the transition period, will require notified body certification from an EU-27 notified body in order to continue to be legally placed on the EU market.
According to NANDO, SGS United Kingdom Limited (NB0120) and BSI Assurance UK Ltd (NB 0086) remain notified under the Medical Device Directive 93/42/EEC (MDD) and the In vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD). This means that SGS and BSI can continue operations under these Directives up to the UK withdrawal date. UL International (UK) Ltd (NB 0843) has a limited scope of designation under the IVDD and was denotified on 2 September 2019 under the MDD. Similarly, Lloyd’s Register Quality Assurance Ltd (LRQA, NB 0088) was denotified under the MDD and IVDD on 1 October 2019.
In order to ensure clients could continue to have market access to the EU, some UK notified bodies decided to establish in the EU-27 and/or partner with existing notified bodies based outside of the UK. BSI established a notified body in the Netherlands called BSI Group The Netherlands B.V (NB 2797). SGS expanded the MDD designated scope of the SGS Belgium NV (NB 1639) notified body and UL International (UK) Ltd formed a partnership with Polish notified body, Polskie Centrum Badan I Certyfikacji S.A. (PCBC, NB 1434). Therefore, UK notified bodies have put mechanisms in place to transfer CE certificates to their EU-27 established and/or partnered notified body. The HPRA understands that the majority of CE certificates originally issued by UK notified bodies have transferred to these EU-27 entities.
Manufacturers with devices certified by a UK notified body should consult with their notified body and ensure that a certificate transfer agreement is in place in order for continued access to the EU-27 market after the end of the Brexit transition period on 31 December 2020.
Following the withdrawal date, UK NBs will lose their status and will be removed from the NANDO website.
Preparation for no-deal Brexit
If manufacturers, authorised representatives or distributors/suppliers wish to continue to place certified medical devices on the EU-27 market after Brexit, the following should be considered:
Manufacturers and authorised representatives placing medical devices on the market that are certified by UK notified bodies will need to ensure the certificates have transitioned to an EU-27 notified body before the withdrawal date.
Manufacturers with a UK authorised representative must transition to an EU-27 authorised representative before the withdrawal date.
Manufacturers and authorised representatives must ensure the labelling is in compliance with the requirements to have an EU-27 notified body and/or authorised representative identified on the labelling as appropriate. Manufacturers and authorised representatives should ensure documentation (e.g. declaration of conformity and device certificates) reflects the EU-27 notified body and/or authorised representative. Documentation should also be maintained to identify the date of manufacture.
Manufacturers and authorised representatives establishing in Ireland are required to register their organisation and device details with the HPRA. Please contact firstname.lastname@example.org to register an organisation establishing in Ireland as a result of Brexit. Organisation details and device information should be submitted to the HPRA before the UK withdrawal date to avoid potential delay in placing devices on the EU-27 market.
Distributors sourcing devices from UK distributors or UK manufacturers will become EU-27 importers for devices they place on the EU-27 market.
On 13 March 2020, the EU Commission published a revised and consolidated document of the 2018 stakeholder notice and the 2019 FAQ document to provide further information on the impact of a no-deal Brexit on medical devices (and other products covered under the New Approach legislation). This document seeks to present advice to stakeholders and highlights some of the implications on certification, labelling, representation and supply in the event of no deal. This document is available on the EU Commission's website.
Additionally, on 9 July 2020 the EU Commission published a communication document on the readiness of the EU and the UK at the end of the transition period. This presents information on the systems and process changes that will occur after the Brexit transition period ends on 31 December 2020.
The HPRA is continuing to work with the European Commission and other Member States in relation to medical devices issues arising from Brexit.
The HPRA encourages any patients, healthcare providers, notified bodies, distributors, manufacturers or their authorised representatives to contact us with specific questions or concerns about medical devices supply or other devices issues in the context of a "no-deal" Brexit.
Phone: Call HPRA reception on +353-1-6764971 and ask to be connected to the Medical Devices department.
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
EU Commission communication on readiness at the end of the transition period between the EU and UK 2020