New MDR and IVDR Factsheet from the European Commission
A new MDR and IVDR Factsheet for healthcare professionals and health institutions was published on 18th December by the European…
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Team NB Releases Document on the MDR Certification Process
Team NB has released a new document titled “MDR Certification Process (including Pre-application, Application, and Post-application Phases) – Consensus Document.”…
EU MDR/IVDR Update: Revised MDCG 2019-13 Sampling Guidance
The European Union has released an update to MDCG 2019-13 rev.1, the guidance document for the sampling of Class IIa…
Member States Endorse COMBINE Program for Medical Devices
Member States have officially endorsed the COMBINE program, a significant initiative aimed at streamlining the combined studies of medicines and…
In-House Medical Device Manufacturing within Great Britain
A new guidance document has been published regarding the in-house manufacturer of medical devices within Great Britain. This guidance is…
FDA Updates GUDID Guidance: GMDN Codes and Enhancements
The FDA has issued updates to the Global Unique Device Identification Database (GUDID) guidance, reflecting changes to the Global Medical…
AI and Machine Learning in Medical Device Regulatory Compliance
Artificial intelligence (AI) and Machine Learning in regulatory compliance is a rapidly advancing field within the science and technology sector.
MHRA Updates Medical Devices Regulatory Reform Roadmap
An updated Medical Devices Regulatory Reform Roadmap, Version 2.0 has been released by the MHRA (Medicines and Healthcare products Regulatory…
New Clinical Trial Regulations in the UK
New draft proposals on clinical trial regulations in the UK have been developed collaboratively by the NHS Health Research Authority…
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