The UK does not currently impose any regulatory requirements additional to those set out in the Medical Devices Directive. Therefore, medical devices which have satisfied the EU regulatory regime, are marked with a CE mark and have been allocated a CE certificate by a Notified Body can be placed on the market in any UK Member State, including the UK.
Once the UK leaves the EU it will cease to be part of the EU's regulatory regime. The Medical Devices Regulations will be amended to introduce a new regulatory regime which will require all medical devices placed on the UK market to be registered with the MHRA. However, the revised regulations will mirror those applicable in the EU, including the updated regime being introduced by the Medical Devices Regulation (effective from May 2020). If the device manufacturer is not established in the UK, the MHRA registration must be conducted by a 'UK Responsible Person'.
Following Brexit there will be a period of grace during which all devices currently marketed in the UK must be registered with the MHRA (if they are not already). The length of this period varies from 4 to 12 months according to the classification of the device.
As the UK's new regulatory regime will mirror the EU rules, the new UKCA mark will not need to be applied to medical devices, which can continue to use the CE mark to indicate regulatory compliance. This will be particularly beneficial for manufacturers of products which are marketed both in the UK and in the remaining EU Member States.
How Medical Devices are Currently Regulated
In the UK, all medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards.
Ophthalmic products are regulated by Directive 93/42/EEC on Medical Devices (MDD) which is transposed into UK law by the Medical Devices Regulations 2002 (the Regulations). Provided that a product complies with the requirements of the MDD, as reproduced in the Regulations, it can be marketed in the UK without having to satisfy any additional requirements.
Devices are separated into four classes (Class I, Class IIa, Class IIb and Class III) according to the level of risk they pose, with Class I products deemed to pose a low risk of harm, Class II products a medium risk and Class III products a high risk.
Manufacturers of Class I devices can self-declare conformity with the MDD before affixing the CE mark. On the other hand, Class II and Class III devices must be certified by an independent conformity assessment body, known as a 'Notified Body', before the CE mark can be affixed.
Notified Bodies are monitored by their national authority (the MHRA in the UK) following a process of designation involving joint audits by two other national authorities and the European Commission.
Regulation of Medical Devices if there is a No Deal Brexit
If the UK leaves the EU on 29 March 2019 without a deal, the UK's participation in the European regulatory framework for medical devices would end and the MHRA would become solely responsible for medical devices placed on the UK market.
For a time-limited period, the UK will continue to allow devices to be placed on the UK market which conform with the MDD, with relevant labelling requirements also continuing to apply, including the need for MDD compliant products to be affixed with a CE mark and be issued with a valid CE certificate following a conformity assessment by a Notified Body.
Following a no-deal Brexit, UK-based Notified Bodies will no longer be recognised by the EU, meaning that devices certified by such UK-based institutions will not be able to be placed on to the EU market without completing a conformity assessment carried out by an EU-based Notified Body.
The UK Government will allocate UK-based Notified Bodies ongoing legal status and continue to recognise the validity of certificates issued prior to 29 March 2019, allowing products covered by certificates issued by UK-based Notified Bodies to continue to be placed on the UK market after 29 March 2019.
After 29 March 2019, all medical devices will need to be registered with the MHRA prior to being placed on the UK market. As this will involve an extension of the existing registration requirements, there will be a grace period to allow time for compliance with the new registration regime as set out below:
- Class I Devices – 12 months;
- Class IIa Devices – 8 months; and
- Class IIb & Class III – 4 months.
Initially, the MHRA will require the majority of products to be registered at the level of the Global Medical Device Nomenclature (GMDN) code meaning that groups of similar products can be combined under a single registration (this will not apply to Class III devices which must have individual product information registered).
Through the no-deal statutory instrument, the Regulations will be amended to establish the new regulatory system which will mirror the key elements of Regulation 2017/745 on Medical Devices (MDR) which will be brought into force in line with the EU's implementation timetable (i.e. full implementation from May 2020). Once the revised regulatory arrangements (i.e. those mirroring the MDR) are in place, all products will need to be individually registered with the MHRA.
Where a device manufacturer is not established in the UK, registration of the product with the MHRA must be undertaken by a 'UK Responsible Person' established in the UK, with a UK registered address, who will be responsible for the product in the UK. This will not require any labelling changes.
The Association of British HealthTech Industries (ABHI) has reassured its members that the UKCA product safety mark being introduced to replace the CE mark will not apply to medical devices. This means that medical devices which comply with the UK's post-Brexit regulatory regime can continue to use the CE mark as evidence of such compliance, as the UK regime will mirror the revised EU system due to be implemented through the MDR.