The CE mark is a universally accepted conformity mark deemed to fit the demands of the European Union’s safety, health, and environmental protection requirements. Any business that wants to do trade in the European Economic Area (EEA) needs to have this mark to send products to market and tap into the potential that comes with the single market.
With the advent of Brexit, questions were raised about whether British products would use CE marks or other systems designed by the government, namely the UKCA mark.
However, the government has recently announced an extension to the validity of CE marks to allow businesses more time to transition to the new UKCA system.
So, what does this mean for the medical device development industry?
Why is a CE mark significant for trade?
CE marking is essential for the development of medical devices in the UK because it demonstrates that the manufacturer has followed the necessary procedures and standards to ensure the safety and performance of the device.
To obtain a CE mark for a medical device, the manufacturer is responsible for carrying out a conformity assessment, which involves evaluating the product’s compliance with the relevant essential requirements.
Manufacturers must also create a technical file that contains all the necessary information about the device. Upon completing these steps and ensuring compliance, the manufacturer can issue the EC Declaration of Conformity (DoC) and affix the CE marking on the product.
Importers of medical devices from third countries are also obligated to check that the manufacturer outside the EU has undertaken the necessary steps and has the required documentation in place. Distributors have the responsibility to verify the presence of the CE marking and the supporting documentation when they handle the products.
It’s important to note that the CE mark does not indicate that a product was manufactured within the EEA, but rather signifies that the product meets the requirements to be sold in the European market.
This in-depth process often involves various costs as well as time commitments and expertise; leading to potentially large outlays for smaller firms. By allowing the continuation of CE marks, British businesses can prepare for the change to UKCA in their own time and plan the costs, paperwork, and validity testing required.
What the CE Mark extension means for UK medical device development
The UK government has introduced a statutory instrument that allows for an extended acceptance period for CE-marked medical devices on the Great Britain market. This means that CE-marked medical devices will continue to be accepted beyond the previous deadline of 30 June 2023. The purpose of this extension is to ensure the ongoing and safe supply of medical devices in Great Britain and to allow for a smoother transition to a strengthened regulatory framework for medical devices in the future.
Moving forward, the government intends to implement the revised regulatory framework from July 2025, taking into account feedback and concerns regarding the limited capacity of conformity assessment bodies. This step-by-step approach aims to ensure everyone is ready for the changes and minimise the risk of supply disruption for patients in the UK.
This move was supported by the EU, in March 2023, as it granted manufacturers additional time to obtain certification for certain medical devices under the EU Medical Devices Regulation (EU MDR), including extending the validity of certain CE certificates.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has also updated its guidance to reflect these planned changes. The MHRA Chief Healthcare Quality and Access Officer, Dr Laura Squire, supported this news with a statement:
“Our priority is ensuring that patients have safe access to medical devices, and we welcome these changes which will help mitigate the risk of shortages of medical devices available on the market.
We know that the medical device industry has had concerns about the expiry of certificates. We have been working with them to grant exceptional use authorisations where there is a public health need. We welcome the EU changes to renewals which will mean for many manufacturers supply to the UK can continue without the need for an exceptional use authorisation.”
How Europlaz can support medical device development
As you can see, this change is largely positive, allowing businesses to update their practices before the switch to the UKCA mark. It also means that trade between the EU and the UK remains relatively stable, providing more confidence for medical device development projects between the UK and EU member states.
To this end, we are pleased to offer our expertise in medical device design, prototyping, and production. From autoinjector kits to bespoke medical application equipment our team can help you develop products for the market.
We also provide added peace of mind with a rigorous Quality Management System (QMS) based on ISO 13485:2016, the European Medical Device Directive 93/42/EEC, and FDA 21 CFR part 820 Quality System Regulations for medical devices.
Work with us today and discover how we produce high-quality medical devices, assemblies, and parts, from design to rollout. If you are interested in finding out more about the process above or want to get started on your next medical device project contact us today. Our team is ready and waiting to help you plan, design, and create medical devices for rollout in the UK, the US, the EU and across the world.