Medical devices regulation and Brexit

Medical devices regulation and Brexit As we begin life outside of the EU, we New UK legislation: summarise in this brief article the proposed New draft UK legislation, governing the placing of approach that manufacturers and suppliers of medical devices on the UK market, is currently medical devices need to do adopt in order to awaiting UK parliamentary approval. The place a medical device on the United Kingdom proposed legislative approach is intended to apply (‘UK’) and European Union (‘EU’) markets from 1 to the UK instead of the delayed EU Medical January 2021. Devices Regulation (‘MDR’) and In Vitro Diagnostic Medical Devices Regulation (‘IVDR’) (which will The draft legislation (still to receive UK now apply in the EU from 26 May 2021 and 26 May parliamentary approval) introduces, amongst a 2022 respectively). range of requirements, a new UK Conformity Assessed Mark (‘UKCA’) and business registration The new draft legislation outlines different requirements for devices manufactured and requirements that will apply to medical devices supplied in England, Wales and Scotland (‘GB’) as placed on the market in GB compared to those well as the need to maintain existing European placed on the market in NI (a consequence of the equivalents for devices supplied to the EU and Northern Ireland Protocol). Northern Ireland (‘NI’) markets. Until this legislation is passed, the Medical Devices Regulations 2002 (derived from current EU Our summary is based on guidance published by legislation) continue to have effect in GB. the UK Government on 31 December 2020 and new draft legislation that is still subject to UK parliamentary approval.

The UK’s regulator: Manufacturing and supplying medical devices The Medicines and Healthcare products in NI: Regulatory Agency (‘MHRA’) has now taken over Under the Northern Ireland Protocol, from 1 responsibility for the UK medical devices market January 2021, the rules for placing medical from the EU system, becoming the UK’s devices on the NI market differ from those standalone regulator for medicines and medical applicable to GB. Key points for stakeholders to devices. be aware of include: Manufacturing and supplying medical devices • The MDR and IVDR will apply in NI (from 26 in GB: May 2021 and 26 May 2022 respectively). From 1 January 2021, there are changes to how medical devices are placed on the GB market. Key • CE marking remains a requirement for medical points for stakeholders to be aware of include: devices placed on the NI market. • All medical devices and in vitro diagnostic • GB based manufacturers need to appoint an EU devices placed on the GB market after 1 January or NI based Authorised Representative to place 2021 need to be registered with the MHRA - there devices on the NI market. will be a grace period for registering certain classed devices. • Certain medical devices, including in vitro diagnostic devices, placed on the NI market need • The UKCA, issued by UK Approved Bodies, is to be registered with the MHRA. Registration available for manufacturers from 1 January 2021 - timings for certain classes of device are subject the UKCA will become mandatory after 1 July to grace periods - Class I devices, custom-made 2023. devices and general in vitro diagnostic devices are required to be registered from 1 January 2021. • Any medical device must have either a UKCA or CE mark - CE marking (including self- Manufacturing and supplying medical devices certification) and certificates issued by EU- in the EU: recognised Notified Bodies will continue to be From 1 January 2021, all medical devices placed valid until 30 June 2023. on the EU market must adhere to the applicable EU legislation and be affixed with the CE mark • UK Notified Bodies are no longer able to issue to demonstrate compliance. Key points for CE certificates (other than for the purposes of CE stakeholders to be aware of include: UKNI marking, valid in NI) and have become UK Approved Bodies. • UKCA marks are not recognised in the EU or NI markets. • Registration with the MHRA requires a registered place of business in the UK - manufacturers based outside of the UK that wish to place a product on the GB market will need to appoint a single UK Responsible Person who takes responsibility for the product in GB.

• Where a UK-based Notified Body has been used Chris Williams to conduct mandatory third-party conformity assessments prior to 1 January 2021, those devices Partner may remain on the EU market - this will cease to +44(0)29 2039 1877 apply to new assessments conducted by a UK [email protected] Notified body after 1 January 2021. David Beynon • Regardless of when products were placed on the market, an EU or NI based Authorised Senior Associate Representative must be appointed. +44 (0)29 2039 1709 [email protected] • Manufacturers that currently CE mark on the basis of self- certification can continue to do so after 1 January 2021 for the EU market. While manufactures of medical devices will need to get up to speed quickly on the new regulatory landscape in GB, NI and EU, the end of the Brexit transition period, and conclusion of ‘The EU-UK Trade and Cooperation Agreement’, has provided welcomed clarity to the sector. Geldards will continue to monitor developments and share details as they become available. geldards.com +44 (0)844 736 0006* @geldards This document is intended solely as an overview of the law in England and Wales. It was last updated on 01.08.16. No responsibility can be accepted for the completeness or accuracy of this briefing note and professional advice should be taken in relation on to any specific matter. Geldards LLP is a limited liability partnership registered in England and Wales (OC313172) and is authorised and regulated by the Solicitors Regulation Authority. A list of Geldards LLP members is available for inspection at our registered office at 4 Capital Quarter, Tyndall Street, Cardiff, CF10 4BZ. We use the word ‘Partner’ to refer to a member of the LLP or an employee of an equivalent standing and qualification. * Please note that the cost of calling our 0844 numbers will include a “service” charge of 6p per minute and an “access” charge from your phone company. Geldards will not receive any payment from the call charges.