MDSS News & Views

The MHRA has updated their guidance on "Regulating medical devices in the UK" with changes to some key topics: ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.

We want to draw your attention to "Register medical devices to place on the market", which provides a very detailed guidance on "Registration of certain medical devices that have expired/expiring CE certificates" and "Registration of certain medical devices which are EU MDD Class I reusable surgical instruments or EU MDD Class I medical devices upclassified from Class I". 

You can access the guidance document for these specific situations here.

If you find yourself in any of these scenarios, please do not hesitate to reach out to us, and we will provide you with the necessary assistance to navigate this process.

Comment on youregulate...

The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! 

Subject to Parliamentary approval, the UK plan is to to introduce legislation before 30 June 2023, which will establish new significant timelines for CE marked medical devices to continue to be placed on the Great Britain market:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028    
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and    
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030.

Here is the link to the updated Implementation of the Future Regulations.

Comment on youregulate...