With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance on regulating medical devices. Given the current circumstances, the Brexit transition period will end without a trade deal in place on December 31st.
Post- Brexit Transition Guidance in Brief:
On September 1st, the UK Government released new post-Brexit transition guidance on medical device regulations. The Medicines and Healthcare products Regulatory Agency (MHRA) states that it will develop its own system after careful consideration of international standards and global harmonization.
From January 1st, 2021, the MHRA will assume responsibility for the UK medical device market. Following the new regulations, must register medical devices of all classes with the agency.
Depending on the risk of the device, manufacturers will get a grace period of 4 to 12 months to comply with the new registration process. During this period, the higher-risk devices require an earlier registration.
Manufacturers must appoint a UK Responsible Person outside the UK to register devices with the MHRA in line with the grace periods.
Overview On MHRA
MHRA is responsible for regulating the UK medical devices market. This guidance only applies to medical devices.
It does not apply to other CE, or UKCA marked products. This information is for guidance only. For more information on the regulatory system for medical devices in Northern Ireland, please see the Regulation of Medical Devices in the UK.
You need to consider whether you need separate professional advice before making a specific preparation before making specific preparations for the market.
Ask your solicitor or trade association if you are unsure which regulatory framework applies to your goods. For example, here is a guide to preparing for the medical device market in Great Britain, England, Wales, and Scotland.
MHRA Regulations Post Brexit
UK’s MHRA will take over the current European responsibilities for medical devices and IVDs from January 1, 2021.
The MHRA has published guidance on the new rules that will govern the regulation of medical devices in Great Britain. Different rules will apply to Northern Ireland post the transition period.
There are several changes under consideration. The changes to the current rules to ensure medical device certification, conformity assessment, and registration of devices already in the UK markets will be considered in the key requirements for device certification and conformity assessment.
The UK’s Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) offers guidance on how the UK system will operate.
Registration with MHRA
Must register medical devices with the MHRA from January 2021. Must now register medical devices placed on the UK market. From January 2021, medical devices of all classes and IVDs must be. Registered with MHRA. With the following timelines: Medical devices of all classes must.
UKCA Mark for Medical Devices
From 1 July 2023, the UKCA requires to place a device on the UK market. Products will therefore have to comply with UKCA marking requirements.
Uk products will require UKCA(UK Conformity Assessed) mark to meet the requirements of UKCA to buy a product from the UK in the UK at the cost of around £1,000.
The CE mark will be accepted by EU recognized notified bodies until 30 June 2023; and will not change for devices placed on UK markets until the end of the next year.
CE marks issued by EU notified bodies would remain valid until July 1st, 2023. Post which all medical devices in the UK (England, Scotland, and Wales) will need a UKCA (UK Conformity Assessed) mark. However, UKCA marking alone will not be recognized in the EU.
Moreover, Post an assessment of whether the products meet the UKCA mark requirements. The MHRA shall have the authority to designate UK-approved bodies.
UK notified bodies, currently working under EU directives. They will automatically become UK-approved bodies from January 1st, 2021, without undergoing new designation processes.
Earlier this fall, UK regulators provided important guidance to medical device manufacturers regarding placing a product on the EU, Great Britain, or Northern Ireland markets starting January 2021.
The MHRA offered new details on Northern Ireland in a recent update as follows:
Northern Ireland (NI):
Under the terms of the withdrawal agreement, NI is different from the rest of the countries of the UK. Since Northern Ireland shares a land border with an EU country, the Republic of Ireland. There was a potential for Brexit to create a hard border between the Irish nations. Leading to a potential threat to peace (since the 1998 Good Friday Agreement).
Under an arrangement known as the NI protocol, goods will not need to be checked along the Irish border when the new UK-EU relationship begins on January 1st, 2021.
This protocol will remove the need for checks on goods traveling from Northern Ireland (a non-EU country) into the Republic of Ireland (an EU country).
To eliminate the need for checks, NI will continue to enforce the EU’s customs rules under the protocol. And will follow its rules on product standards (known as the single market on goods).
Thus, Northern Ireland will keep one foot in the EU, creating the potential for checks on goods coming from other parts of the UK.
There are different rules to place medical devices on the Northern Ireland (NI) market compared to the UK.
Like the EU, CE marking and EU MDR/IVDR will be a continued requirement applicable in this region.
Manufacturing and Supplying Devices in Northern Ireland
Major changes to the regulations to be made on January 1, 2021. Changes will be applicable for manufacturers based in Northern Ireland.
The Agency claims its commitment to improving the standards and scrutiny of medical devices that reach UK patients.
It is highly recommended for medical devices manufacturers to understand the respective Regulatory changes and prepare for a smooth. Transition before in hand. Aren’t you Brexit-ready yet? Gain insights. Stay informed. Get help. Stay compliant.
Registration and UK requirements for responsible persons for Northern Ireland
Must register medical devices placed on the Northern Ireland market with the MHRA. The precise requirements depend on the location of the manufacturer, the location of the Authorized Representative, and the device class.
You must appoint a single UK Responsible Person within the UK for devices that are placed in Northern Ireland. The timelines for registering medical devices with MHRA are set out below.
It is possible that a single entity can act as both a UK Representative in Northern Ireland and a single manufacturer in the UK.
If you are an EU or EEA-based manufacturer, you are required to appoint a UK Responsibility Person. Great Britain manufacturers must also appoint an Authorized Representative based in the EU or Northern Ireland.
CE marking for the Northern Ireland market and implications for the UK-approved Bodies.
A CE mark has been required for devices placed on the Northern Ireland market. UKCA mark is available for use in Great Britain but not for the EU.
To use an EU-recognized Notified body to conduct a mandatory third-party conformity test, you must use a not recognized body not recognized in the UK. You can CE mark based on self-certification for the Northern.
EU rules need to be met for devices to have a CE mark in Northern Ireland and the EU approved by an EU body to comply with any EU. The results of conformity assessments carried out by UK Notified Bodies are not recognized within the EU.
Regarding conformity assessment, a new conformity marking, UKNI, will be required for placing products in the NI market. Companies that use a UK body for the mandatory third-party conformity assessment must apply a UKNI mark alongside a CE mark.
NI can place qualifying goods in the UK market based on the conformity markings already used in NI.
However, the EU will not recognize the UKNI mark, and typically devices placed on the EU market must carry a CE mark only.
Moreover, devices sold in England, Scotland, and Wales will need a different mark, i.e., UKCA.
However, these countries will continue to accept CE marks until the end of 2021.
The CE and UKCA markings are mandating for the Devices to launch in the EU market.
Post the transition period, registration with the MHRA is important for certain medical devices. These devices include in vitro diagnostic medical devices (IVDs) placed on the Northern Ireland market.
Beginning January 1st, 2021, registration is required for Class I devices and general IVDs already on the market by Northern Ireland manufacturers and Authorized Representatives based in Northern Ireland. Other device classes will get a grace period for registering as follows:
- Class IIIs and Class IIb implantable, and all active implantable medical devices and IVD List A products: registered from May 1st, 2021
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs: registered from September 1st, 2021
- Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorized Representative when placing devices on the Northern Ireland market,
UKCA mark and CE marking must appear on devices placed on the Great Britain market. The device will not require re-labeling with either mark until 1 July 2023.
Both marks must be present on the labeling before that date. Devices can still have dual marks on the product labeling before the 2023 deadline.
Device manufacturers must have the Notified Body or Approved Body name on the label.
Device manufacturer must include UK Responsible Person’s name and address in the UK to make sure you have a valid UKCA marking on your device.
Devices will have a dual marking before 1 July 2023, when the market opens up for the first time.
A responsible person in the UK
Manufacturers must appoint UK responsible person with a registered office in the UK. They must assume responsibility for registering devices with MHRA. Also, manufacturers must have a registered office at home in the UK to register devices.
Great Britain-based Authorized Representatives are no longer recognized in the EU. If you are a manufacturer outside the EU and want to sell CE-marked devices, you need to appoint an Authorized Representative based on the EU or Northern Ireland to act on your behalf. This means they cannot carry out tasks on the manufacturer’s behalf to place devices on the European market. It means they can only register and act on behalf of a manufacturer that sells CE-marked products to the EU markets. Additionally, you have to determine if you need a representative in Northern Ireland and the UK for other manufacturers.
The UK has clearly set out how it will regulate medical devices after being fully split from the European Union.
The medicines and health care products regulatory agencies outlined plans to continue recognizing the CE mark until July 2023. Giving companies a chance for at least 4 to 12 months to register their devices and In Vitro diagnostics.
Likely, the new regulations will significantly affect the number of approved medical devices available soon. Global Data’s pipeline products database shows that over 17,000 active medical devices are currently in the pipeline, with approximately 42% of these devices in the early stages of development. With a vast majority of devices being developed in the EU and UK. Many will be caught in transitioning approval processes. This can lead to a temporary decline in the availability of approved devices.
Several companies are already struggling to meet the demands and requirements of the MDR/IVDR, leading to increased costs. Coupled with the additional authorization processes required to reach the UK market may lead to delays. This can even deter companies from selling their products in the UK altogether. Companies who would like to place their devices on both the UK and EU markets must continue to track the changes in regulations and prepare for region-specific registration requirements. They need to perform conformity assessment processes in a timely fashion and allocate adequate budgets for the transition.