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MHRA guidance on Regulating medical devices in the UK has been updated!

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.

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Categories: News

New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

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.

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Categories: News

MHRA extended the transition period for MORE!

The MHRA has extended the deadline for full transitioning to the new MORE (On-line Reporting Environment) portal until 31 August 2023. Until the end of August submissions of vigilance reports via AICxml@mhra.gov.uk will still be possible. It seems feedback from actors has been received which led to the extension. However, it is recommended to make yourselves familiar with the new MORE portal as soon as possible to identify any issues with the database. The MHRA vigilance guidance was updated accordingly to reflect this information.

Please note: Reports from the old MORE account should still be downloaded until the end of April! From 1 May the old MORE portal will allow read-only access.

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Categories: News

The UK and Switzerland have embraced the EU MDR extension!


The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical devices may not be available in these markets due to the same reasons. Overall, these are excellent news for the medical devices industry.

However, these countries may not want to rely heavily on the EU approval process. This situation could rapidly change in the future, particularly, as the UK will transition to its own law (with a transition period for CE marking) and with the UKRP in place, while Switzerland will accept FDA with the CH-REP in place. Once this happens, both countries will no longer depend on the EU for their supply of compliant medical devices.

While some may see this as a positive development, historically, different regulatory markets have been used to protect domestic industries, which has not been conducive to the overall prosperity of a region. It remains to be seen how this will play out in the medical device industry. Are we going to see protectionist measures in the future? Only time will tell.

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Categories: News

Extension of the MDR for legacy devices!

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is  MDSS' outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official pages.

*The adopted proposal still has to go through the legislative procedure to be adopted as law!

Join our Online Seminar where we will discuss the extension and the impact of Article 97 and address how Switzerland and the UK are acting!

Categories: News

MORE Portal - UK!

The new MORE (Manufacturer's On-line Reporting Environment) Portal was lunched on Monday 5th December 2022 and is now available for submission of reports relating to adverse incidents for medical devices.

To submit via the new MORE portal, you will need to register for a MORE account.

Here is the link to the official page on Medical devices: guidance for manufacturers on vigilance with further information and instructions.

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Categories: News
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