“Explore the impact of Brexit on medical device regulations in the UK. Learn about UKCA marking, MHRA guidance, clinical trials, and compliance for safe and effective products.”
The UK’s departure from the European Union (EU) has brought some major regulatory amendments for medical devices regulated in the Great Britain market. For this article, we will go over the new Brexit rules for medical devices and define some essential terms that a pharmaceutical manufacturer must know.
Regulations and UKCA Marking
Following Brexit, the UK has introduced new regulations for medical devices, significantly altering how products are marketed and sold within the country. Prior to Brexit, medical devices in the UK were regulated under EU laws, with the CE mark serving as proof that the product met the necessary safety and performance requirements. However, with the UK leaving the European Union, the UK established its own regulatory framework for medical devices, requiring the UKCA (UK Conformity Assessed) mark instead of the CE mark for devices placed on the UK market.
Key Implications of the UKCA Marking
UKCA Marking Requirement:
The UKCA mark, introduced by the UK government as part of the Medicines and Medical Devices Act 2021, is now required for medical devices sold in Great Britain (England, Wales, and Scotland).
The CE mark remains valid in Northern Ireland under the Northern Ireland Protocol, meaning CE-marked devices can still be marketed there, but manufacturers must also comply with specific regulations set by the European Union.
Transitional Period:
While the UKCA marking became mandatory for new products placed on the UK market starting January 1, 2021, a transitional period has allowed for continued use of the CE mark for certain medical devices until July 1, 2024. After this date, the UKCA marking will be fully enforced for all medical devices and in vitro diagnostic devices (IVDs) placed on the UK market.
Conformity Assessment:
Just like the CE mark, the UKCA marking signifies that a device complies with UK regulations regarding safety, quality, and performance. Manufacturers must perform a conformity assessment to ensure their product meets these standards.
For higher-risk medical devices, the manufacturer must involve a UK-approved Notified Body (now known as a “UK Approved Body”) to assess the product’s compliance, especially for Class IIa, IIb, and III devices.
Labeling and Documentation:
Devices placed on the UK market after July 1, 2024, must carry the UKCA mark. This includes updated labeling, which must reflect the UK regulations and show the UKCA symbol.
Manufacturers must also update their technical documentation to reflect UK-specific requirements, including providing contact details for a UK-based Responsible Person if the manufacturer is located outside the UK.
Notified Bodies and UK-approved Bodies:
Manufacturers must now ensure their conformity assessment is conducted by a UK-approved body (equivalent to the EU’s Notified Bodies) if their device requires third-party involvement.
Some EU-based Notified Bodies have been designated by the UK government as UK-approved bodies to ensure continuity in the conformity assessment process, although many companies will still need to establish separate relationships with UK-approved bodies.
Post-market Surveillance and Vigilance:
UK regulations also include requirements for post-market surveillance, reporting adverse incidents, and maintaining a system to monitor the device’s safety once it is on the market.
This mirrors EU regulations but requires compliance with UK-specific reporting channels and timelines.
Impact on Manufacturers and Importers
Manufacturers Outside the UK:
For manufacturers based outside of the UK, the UKCA marking imposes additional steps to enter the UK market, including appointing a UK Responsible Person who is based in the UK. This person is responsible for ensuring the manufacturer’s devices comply with UK regulations.
Importers and Distributors:
Importers and distributors in the UK are required to keep records of the products they import and place on the market, as well as ensure that these products comply with UK regulations.
Re-certification:
If a manufacturer has previously received CE certification for their products, they may need to go through a re-certification process with a UK-approved body to secure the UKCA mark before placing their devices on the UK market.
MHRA Guidance
In response to these new regulations, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for medical device manufacturers. This guidance provides information about clinical investigations, certification, conformity assessment and responsible persons.
Clinical Investigations
Post-Brexit, these new regulations will apply to devices used in clinical investigations of medical devices in the UK. In the UK, GCP standards will remain and if manufacturers are conducting clinical investigations this should continue to be met.
Certification And Compliance Test
Medical device manufacturers will need certification from a UK-approved body to place their products on the market. This certification process will demand proof that the medical device can comply with UK regulatory rules. Manufacturers, in addition to conducting the conformity assessment of their products under new regulations.
Responsible Person
Under the statutory instrument, medical device manufacturers will be required to appoint a UK-based responsible person who has oversight and responsibility for meeting relevant regulatory requirements. The person responsible will then be accountable to confirm that the medical tool complies with UK regulations and labeling is in place.
Implementing Import/Export Rules & Supply Chain-health
The vote to leave the European Union (EU) has already caused changes concerning medical device import/export standards in Britain. They will have to meet new import/export customs procedures and border controls. The regulations has placed more stringent controls over the medical device supply chain, necessitating manufacturers to verify that their components suppliers are complying with the new tighter requirements of MDRs.
Build their skills in Innovation and Quality Control.
Medical device innovation in the UK can be very beneficial to people post-Brexit. Furthermore, manufacturers of innovative products will have to ensure their product complies with the new regulatory rules. Equipment manufacturing also has a big quality control aspect and manufacturers must make sure that the products meet all requirements of high standards.
Clinical Trials and Labeling
Brexit has ramifications on the need to conduct clinical trials of medical devices within the UK. Here, the MHRA will do so by imposing new clinical data requirements for manufacturers wishing to conduct trials in a UK setting. Furthermore, manufacturers will have to ensure that their products are correctly labeled within the frames of new regulations.
Vigilance and Recalls
Suppliers will need to have vigilance procedures in place under the new Regulations. It also needs to monitor its products for adverse events, and report these to the MHRA. Manufacturers will also need protocols for recalls.
Certification Procedure and Register Process
They also apply to the certification process that manufacturers of medical devices must now follow for their product to be accompanied by a UKCA mark. In addition, they have to undergo product registration with the MHRA before being made available on Great Britain’s market.
Directives and Mutual Recognition between the EU-UK
The UK has published new medical device regulations that replace the EU medical device directives that were previously used in the UK. However, the UK and EU did come to a mutual recognition agreement for medical devices so that their products have easier market access.
Conclusion: Adapting to the New Regulatory Landscape
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