Skip to main content
Blog-Banner (1)

Medical Devices-USA/Europe Regulatory News-September 2023

|
  • Have been placed on the market as self-testing devices and have a certificate issued by a notified body  (i.e. they have been verified by an independent institution),
  • Have the number of the notified body that certified this test next to the CE mark ,
  • Have packaging (labels), instructions for use and a user interface in Polish, and
  • Have a clear wording on the packaging (label) and in the instructions for use that they are intended for self-testing.
  • Registration of companies and economic operators – ACT module (available early 2024)
  • Swissdamed – freely accessible platform (available early 2024)
  • Registration of devices – UDI module (available from summer 2024)

Update: Updated Submissions guidance to reflect: Update to screenshots, guidance for draft reports and auto-population of submitter fields. 

https://www.gov.uk/government/publications/more-submissions-user-reference-guide#full-publication-update-history

Update: Added information on fees payable in relation to clinical investigation and amendments to clinical investigations

Update: Published – Intertek Medical Notified Body UK Ltd Medical Devices Scope. 

Update: Updated ‘Certificates of Free Sale for Medical Devices’ reference guide. 

Update: Updated – Account Management Reference Guide & Device Registration Reference Guide.

Update: Guidance updated to reflect the latest information regarding the MORE portal.

  • 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 the expiry of the 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 the expiry of the 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 30 June 2030.
  • Declaration of conformity,
  • Manufacturer self-declaration letter,
  • Proof of payment,
  • Device schedule,
  • Unless otherwise stated in the declaration of conformity, a letter confirming the physical site of manufacturer.