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NEWS

News in Brief

Implementing Decision (EU) 2025/1324 on Expert Panels for Orphan Devices

July 11, 2025
News in Brief

New CECP Scientific Opinion Published

July 10, 2025
Important Notice

Electronic Instructions for Use (eIFU) for Professional Use Medical Devices

July 9, 2025
Important Notice

MDCG published guidance 2025-6

July 8, 2025
Important Notice

Guidance on EU MDR/ IVDR and AI Act interplay

July 8, 2025
News in Brief

MDCG 2019-11 rev. 1 published by the European Commission

July 1, 2025
Brexit, Important Notice

MHRA Fee Increase

July 1, 2025
News in Brief

New Q&A Guidance: MDCG 2025-5 on IVDR Performance Studies

June 25, 2025
News in Brief

New MDCG Guidance Alert

June 25, 2025
Important Notice

MHRA celebrates PMS Regulation as the beginning of a new era in UK device framework revolution

June 24, 2025
News in Brief

Notified bodies caution about obstacles hindering their AI designation

June 16, 2025
Brexit

Is it time for the MHRA to adopt a more practical approach to the UK’s regulatory ambitions?

June 15, 2025
News in Brief

Unlocking AI Literacy: What You Need to Know

June 7, 2025
Important Notice

New MIR Form 7.3.1 Now Accepted in Switzerland

June 2, 2025
News in Brief

European Medical Devices Nomenclature (EMDN) helpdesk is live!

May 31, 2025
Important Notice

European Commission publishes updated version of the Manufacturer Incident Report (MIR)

May 7, 2025
Important Notice

More standards under MDR and IVDR harmonized

May 5, 2025
News in Brief

News from Team-NB

May 4, 2025
News in Brief

UK MHRA postpones increase in device registration fees

April 16, 2025
Important Notice

EUDAMED Workshop – Preparing for Compliance

April 8, 2025