The medical device regulations in the UK have now changed. From the 1st of January 2021, a new medical device regulation was introduced by the UK Government in line with the end of the Brexit transition period. This update is vital to understand Medicines and Healthcare products Regulatory Agency (MHRA) medical device regulations and how you will need to adapt your testing and productions to keep up with deadlines.
The new regulation includes a number of changes to medical device manufacturing in 2021. The MHRA will now be responsible for the UK medical device marketing, previously undertaken through the EU system.
At Europlaz, we assist clients with medical device testing, design, and manufacturing. Through our expertise, you can ensure your product is reliable, effective, and compliant with a wide range of governing bodies. To help you better understand the changes to medical device regulations we’ve created a brief guide. If you need more information or would like to find out more about our services please contact us today.
2021 changes to medical device regulation in the UK
The Government has provided guidance on how the UK system will now operate which covers certifying devices, conformity marking devices and registering devices.
In summary, the main 2021 changes to medical devices include:
• CE marking will continue to be used and recognised until 30 June 2023.
• Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023.
• A new route to market and product marking will be available for medical device manufacturers wishing to place a device in the British market from 1 January 2021.
• From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed in the UK market will need to be registered with the MHRA. There will be a grace period for registering which is:
- Four months for Class III and Class IIb implantables, and all active implantable medical devices.
- Eight months for other Class IIb and all Class IIa devices.
- Twelve months for Class I devices.
- The above twelve-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
Click here to find out more about class regulations and which category your device comes into.
How Europlaz is keeping up with the UK’s medical device regulation changes
The medical device manufacturing industry is highly regulated to protect patients. These medical device regulations are ever-changing and as such we are constantly updating our practices in-line with the rigours of the MHRA, ISO, and FDA.
At Europlaz, we have adjusted to all regulations in a quick manner. We are operating in line with the new regulations and will continue to follow any further government or MHRA updates, expected over the next few years.
As a specialist device manufacturer, we are committed to using new medical device regulations to continue to bring our customers’ products from a vision to market. We have a high standard Quality Management System (QMS) in place which every member of our team is expected to follow.
Our QMS is based on the principles of ISO13485:2016, the European Medical Device Directive 93/42/EEC, the FDA 21 CFR part 820 Quality System Regulations for Medical Devices, and the establishment and delivery of related quality objectives.
The Europlaz Quality System means consistently providing a product that meets or exceeds customer and business requirements and continually improving the effectiveness of its business processes/quality management system (QMS).
This is done by providing enhanced customer satisfaction and business performance through the identification, development, implementation and review of a series of quality objectives, for application at all levels of the organisation. Our commitment to ensuring all services adhere to the UK’s MHRA medical device regulations is just one of the ways we ensure our medical device manufacturing services remain at the cutting edge.
To learn more about the medical device regulations we adhere to and why quality control is the foundation of our business click here. For further information on our services, such as medical device fulfilment, feasibility, validation, sterilisation, and risk management please contact us. Our team is ready and waiting to help you develop safe, reliable and cost effective medical devices.
Functions we can assist you with
At Europlaz our highly experienced team can assist you with any of the following:
- CE Marking
- FDA Approval
- Risk Management
- Usability Studies
- Technical File Generation
- Design Transfer
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