The two new Regulations on medical devices (MD) and in-vitro diagnostics (IVD) published in May 2017 are now being implemented with the first provisions already in place and full application expected by May 2020 (MD) and May 2022 (IVD). Undoubtedly, the UK’s exit from the EU will have a significant impact on the implementation of the legislation as the UK’s 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 withdrawal date in the case of a no-deal Brexit, will require Notified Body certification from an EU 27 Notified Body in order to continue to be legally placed on the EU market.
The four UK Notified Bodies, and their Notified Body identification numbers, currently certifying medical devices are identified as follows:
NB 0088 Lloyd's Register Quality Assurance Ltd
NB 0120 SGS United Kingdom Limited
NB 0843 UL International (UK) LTD
NB 0086 BSI Assurance UK Ltd
BSI UK Ltd have established in the Netherlands and we understand that the majority of their certificates are transitioning across to this entity. UL have partnered with another EU27 Notified Body and we understand that the majority of their certificates are in the process of transitioning across to the EU27 entity.
Manufacturers with devices certified by any of these above listed UK Notified Bodies should consult with their NB and have a plan for certificate transfer for continued access to the EU27 market post UK withdrawal.
Following the withdrawal date UK NBs will lose their status and will be removed from NANDO
Preparation for No Deal Brexit
If manufacturers, authorised representatives or distributors/suppliers wish to continue to place certified medical devices on the EU27 market post 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 EU27 Notified Body before the withdrawal date.
- Manufacturers with a UK Authorised Representative must transition to an EU27 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 appropriateManufacturers and Authorised Representatives should ensure documentation (e.g. declaration of conformity and device certificates) reflects the EU27 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 email@example.com 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 EU27 importers for devices they place on the EU27 market
On 1 February 2019, the EU Commission published a Q&A 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 Q&A follows on form the Commission's 2018 notice to stakeholders and highlights some of the implications on certification, labelling, representation and supply in the event of no deal.
The latest Q&A provides examples of when goods are placed on the market and in the supply chain which clarifies the validity of certification from a Notified Body for example. It also provides some clarification from the EU Commission’s perspective on the transfer of Notified Body certificates.
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 who have a specific question or concern about medical devices supply or other devices issues, in the context of a "no-deal" Brexit, to contact us on firstname.lastname@example.org or the medical device department through HPRA reception +353-1-6764971.
EU Commission Q&A
EU Commission Notice to Stakeholders January 2018
EU Commission communication to stakeholders September 2019