UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
Europe – EU plan would limit Chinese device makers in Europe
European Union member states this week voted to support a plan to adopt measures that would restrict Chinese medical device makers’ access to the...
Europe – Study supporting the monitoring of the availability of medical devices on the...
Commissioned by: The European Commission’s Directorate-General for Health and Food
Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)
• Aim: To support...
UK – The Medical Devices (Amendment) (Great Britain) Regulations 2025 (Draft)
The Secretary of State in exercise of powers conferred by sections 15(1), 16(1)(a), (b), (c), (e), (g) and (i),17(1)(b) and (c) of the Medicines and Medical...
Europe – MIR PDF 7.3.1 New MIR form – mandatory as from November 2025
The Manufacturer Incident Report (MIR) Form v7.3.1 is the official European Union template used for reporting serious incidents involving medical devices under the MDR/IVDR...
UK – Nice recommends first AI medical device for skin cancer diagnosis in the...
NICE has endorsed DERM, an autonomous AI medical device developed by Skin Analytics, for detecting skin cancer. This recognition marks a major step in...
Europe – EUDAMED user guide : UDI Devices
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro
diagnostic medical devices introduce an EU identification system for medical devices
based on...
Europe – European Artificial Intelligence Act (Version 2)
This position paper provides an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation.
Because of the...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II...
General Considerations
The most common reasons for delays in Technical Documentation assessments by notified bodies are:
• Incomplete Submissions – Insufficient or missing information not provided...
UK – Clinical investigations of medical devices – guidance for manufacturers
It is important to note that the rules for notifying the MHRA of a clinical investigation in
Great Britain (England, Wales and Scotland) differ from...
