The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a...
Major Changes to UK MHRA Medical Device Registration Fees
Call to Action in the UK database: Save money by deactivating devices that are no longer placed on the UK market. The UK’s Medicines and ...
New guidance on the PMS requirements has now been published by the MHRA
New MORE Guidance on implementing the changing data requirements for medical device reporting. The MHRA has released a new guidance to support medical...
New MIR Form (Version 7.3.1)
The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
June 2025 Deadline: Stricter UK Medical Device PMS Regulations Published
MDSS is pleased to share that Statutory Instrument 2024 No. 1368 – The Medical Devices (Post-market Surveillance Requirements) Regulations 2024 has ...
MHRA opens consultation on future UK Medical Devices Regulations!
The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a consultation on the future regulatory framework for medical devices in ...
MHRA proposes a framework for international recognition of medical devices!
The MHRA has announced a policy intent to recognize medical device regulatory approvals from Australia, Canada, the EU, and the USA, aiming to ...
Advantages of conducting business in the UK. Possible under the MDR?
There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medi...
Important Announcement: CE-Marking Extensions and Medical Devices in the UK
The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...
Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update
UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No...
