Stay informed on the latest updates in medical device regulatory affairs to enter regulated markets fully prepared.
A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the
On 19 November 2025, the European Commission unveiled the Digital Omnibus package, a legislative proposal introducing targeted amendments to several
On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation
A new development in healthcare cybersecurity is the publication of IEC TS 81001-2-2:2025, which provides updated guidance on the implementation,
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the
The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning
Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a
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