A Quick Look at Medical Device Regulations in the UK
The medical device sector in the UK is overseen by a robust regulatory framework.
The UK MDR framework is there to make sure that medical devices are safe and work properly.
For manufacturers, understanding these rules is important. It helps you deal with the regulatory complexities of creating new medical solutions and bringing them to market.
The UK's regulatory environment for medical devices has evolved over the years. Historically, we followed the European Union's Medical Device Directive (MDD). However, post-Brexit, we have established our own regulatory system. The new UK MDR does still mirror a lot of the principles and structures of the EU's Medical Device Regulation (MDR), formerly known as the EU Medical Device Directive (MDD). This shift does mean that manufacturers and distributors need to adapt to new compliance requirements specific to the UK market while maintaining the high standards of device safety and performance that were already in place.
Who is responsible for regulating medical devices in the UK
The primary regulatory agency overseeing medical devices in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is responsible for making sure that medical devices meet the proper standards before they can be marketed in the UK. They oversee the entire lifecycle of a medical device, from pre-market approval to post-market surveillance.
The Classifications of Medical Devices
Medical devices in the UK are classified into four main categories depending on how risky they may be.
Class I Devices are considered to have the lowest risk. Examples include non-sterile instruments like wheelchairs and glasses. It applies to medical devices that generally don’t need a conformity assessment.
Class IIa Devices are medium-risk devices and include products such as dental fillings and surgical clamps. These need more stringent controls than Class I devices to ensure safety and effectiveness.
Class IIb Devices are also medium risk but are generally considered to pose a higher risk than Class IIa devices. Examples include bone fixation plates and lung ventilators. These devices require a rigorous assessment procedure, which often includes involving an Approved Body.
Class III Devices are the highest risk class and include critical devices such as pacemakers and heart valves. These require the most stringent regulatory controls to ensure a high level of protection for users.
What are the essential requirements for medical devices in the UK?
The essential requirements for medical devices in the UK include:
General safety and performance requirements
Risk management and maintenance of an acceptable benefit-risk ratio
Electrical safety
Mechanical safety
Software lifecycle processes, including verification and validation
Usability of medical devices to minimize risks associated with usability issues
Steps to Getting a Medical Device Approved
When you're developing a medical device intended for the UK market, the initial phase involves thorough research and development to ensure compliance with the essential requirements as outlined by the UK Medical Devices Regulations 2002 and the EU Medical Devices Regulation 2017/745. Being able to verify that your medical device performs as it should do under normal use and then assess any potential undesirable side-effects. Any risks associated with side-effects need to be evaluated to check if they are acceptable when weighed up against the benefits of the device.
If a clinical investigation is needed, MHRA needs to be notified.
Once the MHRA have been notified, they will validate the documents you've submitted and confirm within 5 working days whether your assessment period has begun or if there are any issues needing resolution. The assessment starts the day after the MHRA accepts a valid notification.
Special Considerations for Northern Ireland
Due to the Northern Ireland Protocol, devices in Northern Ireland must align with EU regulations. All clinical investigations in Northern Ireland still need to be submitted to the MHRA however, in accordance with EU MDR requirements not UK requirements.
Understanding the UKCA Mark
The UKCA (UK Conformity Assessed) mark shows that a medical device complies with the essential requirements as outlined in the UK Medical Devices Regulations 2002 in Great Britain, which includes England, Wales, and Scotland. In the EU, EEA, or Northern Ireland, devices must carry a CE mark.
Registering with MHRA
When you register your medical devices with the MHRA, you need to give them comprehensive information outlining your compliance with regulatory standards. This includes the manufacturer's legal name and address, the type of device, and the regulation to which the device conforms among others. You will also need to submit proof of conformity assessment, such as a CE marking Certificate or Declaration of Conformity. If your medical device has not been manufactured in the UK, you need to prove that you are working with UK Responsible Person (funnily enough, that’s something we can definitely help you with).
Timelines
The MHRA typically reviews applications within a five-business day timeframe, although this can vary depending on the current backlog of registrations. If they need additional information from you then this may take longer. Once approved, the manufacturer and the medical device(s) will be listed on the MHRA's public registration database.
Post-Market Surveillance and Compliance Monitoring
Once your medical device is on the UK market, you need to be vigilant about its performance and safety. You can report any adverse incidents that occur involving your devices, or we can do that for you.
The MHRA actively checks that medical devices comply with legal requirements. This involves routine monitoring and specific enforcement duties when non-compliance is reported. If an enforcement notice is issued, the manufacturer has certain rights, including the ability to respond and rectify the situation.
On top of your duty to report adverse incidents, you’re also required to submit Periodic Safety Update Reports – aka PSURs. PSURs help the MHRA to identify and analyse how safe and efficient your device is throughout its life cycle.
Meeting the regulatory requirements in the UK
helps to improve healthcare outcomes
It’s about compliance, but it’s also so much more. The UK MDR helps innovation and improves safety in the medical device industry. If you need help as the regulatory environment continues to evolve, let us help. At Taylored Consultancy, we can help you stay informed and be prepared for changes.