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…
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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…
New Update from Team-NB on Class D Devices
On 12th December, Team-NB published a press release titled: “Important update on the Implementation of Class D oversight by EURLs:…
Public Consultation on EU MDR and IVDR Effectiveness
The European Commission has launched a public consultation to evaluate the effectiveness of the EU Medical Device Regulation (EU MDR,…
Navigating Compliance with AI and Machine Learning in SaMD
The medical device industry continues to grow and evolve, becoming increasingly reliant on technology, making software a crucial component of…
Challenges in Reprocessing Single-Use Devices Under EU MDR
The ‘Report on the Operation of Article 17 of Regulation (EU) 2017/745 on Single-Use Devices and Their Reprocessing’ was…
MDCG 2024-16: New Form for Reporting Device Supply Issues
MDCG 2024-16 was published on Friday 6th December which is a form linked to the Q&A document…
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