The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published guidance on how the UK medical device industry will be regulated once the transition period after Brexit ends on 31 December 2020 (the Guidance). Updates to the UK system will begin to take effect from 1 January 2021, and manufacturers need be aware of the impact of these changes on their regulatory obligations and how the UK medical device market will look from this date. In places, separate rules will apply to medical devices being placed on the Northern Irish market.
Changes in obligations and requirements
When supplying medical devices to the UK market, manufacturers should be aware of the following obligations and deadlines:
1. Registering medical devices with the MHRA
From 1 January 2021, manufacturers must register with the MHRA prior to placing medical devices on the UK market. Manufacturers should therefore plan to register with the MHRA in advance of this date if they intend to supply the Great British market from 1 January. If the manufacturer is not established in the UK, in most cases, it must designate a UK Responsible Person to register and act on its behalf. Medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will also need to be registered with the MHRA from 1 January 2021. To allow time for compliance with the new registration process, there will be a grace period for registering medical devices:
4 months (until 30 April 2021) for Class IIIs and Class IIb implantables, and all active implantable medical devices
8 months (until 31 August 2021) for other Class IIb and all Class IIa devices
12 months (until 31 December 2021) for Class I devices. It is important to note that this grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA. Class I devices, custom-made devices and general IVDs being placed on the Northern Irish market must continue to register as normal as the 12-month grace period will not apply.
2. Action required for manufacturers with a Great Britain based Authorised Representative
For manufacturers with a registered place of business outside the EU, they must appoint an ‘authorised representative’ that is established within the EU to act on their behalf in carrying out certain tasks when placing devices on the EU market. From 1 January 2021, authorised representatives established in Great Britain (England, Scotland & Wales) will no longer be recognised. Manufacturers that previously used a Great Britain based authorised representative must designate a UK Responsible Person when placing devices on the Great British market from 1 January 2021. They must also designate an authorised representative established in the EU-27 or Northern Ireland when placing devices on the EU market from 1 January 2021.
3. UK Responsible Person
The Guidance provides further clarification on the (new) concept of a ‘UK Responsible Person’. From 1 January 2021, manufacturers based outside the UK that wish to place medical devices on the Great British market must use a UK Responsible Person to place the device on the market and take responsibility for the device in the UK. This includes the responsibility to register the manufacturer’s devices with the MHRA prior to placing them on the market. However, the Guidance provides for a grace period for manufacturers to appoint a UK Responsible Person, which corresponds to the grace period set out above for the registration of devices with the MHRA.
The UK Responsible Person must be established in the UK, and a number of organisations are already advertising their services as UK Responsible Persons.
The MHRA’s guidance sets out the responsibilities of a UK Responsible Person:
Ensuring that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
Keeping available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
In response to a request from the MHRA, providing them with all information and documentation necessary to demonstrate the conformity of a device
Forwarding to manufactures any requests from the MHRA for samples, or access to a device, and ensuring that the MHRA receives the samples or has been given access
Co-operation with the MHRA on any preventative or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
Immediately informing manufacturers of any complaints or reports from healthcare professionals, patients and users about suspected incidents related to a device which they have been designated, and
Terminating the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the draft Exit Regulations and inform the MHRA, and if applicable, the relevant notified body of that termination
4. UK Conformity Assessment Procedure
The Guidance references to the new UK Conformity Assessment (UKCA) product marking that will replace the CE mark in the UK from 1 July 2023. The UKCA mark may be used for certain goods, including medical devices, being placed on the Great British market from 1 January 2021.
From 1 January 2021, the UKCA marking may be used for medical devices. As of this date, a CE marked medical device with a valid declaration of conformity or certificate will be viewed as meeting the UKCA mark requirements for as long as the CE mark continues to be recognised in Great Britain, i.e. until 30 June 2023. From 1 July 2023, the CE mark will no longer be recognised in Great Britain and the UKCA mark must be applied to all devices being placed on the Great British market.
5. Effect on Notified Bodies
EU legislation provides for Notified Bodies, which must be established in a Member State and designated by a Member State competent authority, to take part in the conformity assessment procedure for certain types and classes of medical device. From 1 January 2021, UK based Notified Bodies will lose their status as EU Notified Bodies, and will no longer be able to perform conformity assessment tasks to enable products to be placed on the EU market and acquire valid certification.
However, the Guidance retains the concept of Notified Bodies, and stipulates that the MHRA will be able to designate UK Conformity Assessment Bodies from 1 January 2021 to conduct assessments against UK requirements for the purpose of the UKCA mark. UK Notified Bodies with designations under the pre-Brexit framework will have their designations rolled over automatically. These Notified Bodies will be known as Approved Bodies from 1 January 2021. UK Approved Bodies will only be able to conduct conformity assessments in relation to the UKCA mark.
Manufacturers based outside the UK, and based either within or outside the EU, should take note of the timelines set out in the Guidance. They should also be aware of the various actions that are required for continuing to place medical devices on the UK market after the end of the transition period, i.e. from 1 January 2021. While a number of obligations for manufacturers will not take effect for quite some time, there are also a number of new obligations that may need to be fulfilled within the next short few months.
Manufacturers should also be cognisant of the differing treatment for devices placed on the market in Northern Ireland compared with the rest of the UK. Regardless, it is undoubtedly positive that manufacturers are finally being provided with an insight into what the landscape of the UK medical device industry will look like post-Brexit. However, manufacturers are reminded that the situation may still be subject to change and therefore close attention should be paid to further developments over the coming months.
For more information on the impact Brexit is likely to have on marketing your products, contact a member of our Product Regulatory team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.