medical device regulations

Medical Device Regulations

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.

The new regulation includes a number of changes to medical device manufacturing in 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) will now be responsible for the UK medical device marketing, previously undertaken through the EU system.

2021 changes to Medical Device Manufacturing

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:

o Four months for Class IIIs and Class IIb implantables, and all active implantable medical devices.

o Eight months for other Class IIb and all Class IIa devices.

o Twelve months for Class I devices.

o 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 changes

The medical device manufacturing industry is highly regulated and regulations are ever-changing. 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 medical device manufacturer, we are committed to using new 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 adhere to.

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. Whilst developing an appropriate and increasingly skilled and motivated workforce through a training plan linked to the Business Plan.

The company is committed to meeting these needs and expectations through an appropriate and relevant QMS, 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.

We are using our QMS to exceed customer expectations while meeting external requirements such as the 2021 changes to medical device manufacturing. Learn more about our QMS and why quality control is the foundation of our business here. For further information please contact us.

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