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:…
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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…
MHRA Updates Guidance on Serious Adverse Events Reporting
The Medicines and Healthcare products Regulatory Agency (MHRA) issued an important update to its Clinical Investigation Guidance, with a…
FDA Issues PCCP Guidance for AI Medical Devices
The FDA has issued an official guidance (December 2024), related to AI enabled device software marketing submissions and PCCP (Predetermined…
MDCG Guidance: Publishing Clinical Investigation Reports
The Medical Device Coordination Group (MDCG) has issued a new guidance titled ‘Guidance on the publication of the clinical investigation…
Master UDI-DI Solution for Contact Lenses Guidance
Today the Medical Device Coordination Group (MDCG) has released the MDCG 2024-14 guidance document, which provides essential information…
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