October 11, 2022
The MHRA has updated how incident reports can be submitted in the UK. Find out when the old system expires and how to register for the new UK vigilance portal.
August 31, 2022
The MHRA issued a consultation to increase fees for medical device clinical investigation notifications and device registrations. Find out the new fees here.
July 27, 2022
The EU issued Northern Ireland Protocol infringements against the UK. The Protocol allows free movement of goods at the UK/EU border in Ireland. Is that now at risk?
July 21, 2022
The MHRA issued an update on the new UK medical device regulation. What will be similar to the MDR/IVDR, what will be different and when does it takes effect?
June 29, 2022
The MHRA released an update to the proposed new UK regulations. It offers further transition period for UKCA marking and longer timeframe to accept CE Marking. Find out more ...
May 26, 2022
There is extensive activity surrounding the IVDR’s date of implementation today. Here we will discuss what is new, and the impact in the EU, Switzerland, and the UK ...
May 17, 2022
The MHRA updated the designation scope for two UK Approved Bodies, reducing the UKCA coverage for medical device & IVD manufacturers. How does this impact you? ...
March 30, 2022
We hear a lot about the lack of Notified Body capacity and if companies will be able to CE mark to the MDR/IVDR on time. But what about UKCA Marking and the lack of UK Approved ...
January 4, 2022
It’s official, the registration transition period is over. The UK MHRA has updated its guidance on “Regulating medical devices in ...