Stay informed on the latest updates in medical device regulatory affairs to enter regulated markets fully prepared.
EC REP to EU REP: What the OJEU Publication Means in Practice
On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the
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January 6, 2026
EU Digital Omnibus Package: What’s Being Proposed
On 19 November 2025, the European Commission unveiled the Digital Omnibus package, a legislative proposal introducing targeted amendments to several
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December 17, 2025
EU Publishes Draft Rules for AI Regulatory Sandboxes
On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation
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November 21, 2025
IEC TS 81001-2-2:2025 for Health Software and IT Systems
A new development in healthcare cybersecurity is the publication of IEC TS 81001-2-2:2025, which provides updated guidance on the implementation,
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November 18, 2025
Industry Calls for Digital Labels for Authorised Representatives and Importers
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the
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November 5, 2025
EU Commission Final Report on AI in Healthcare: Deployment, Barriers, and Regulatory Priorities
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the
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September 2, 2025
SAHPRA Issues Regulatory Requirements for AI/ML-Enabled Medical Devices
The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning
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August 28, 2025
Health Canada eSTAR Pilot Expanded: What Device Manufacturers Need to Know
Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a
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July 7, 2025
EU AI Act Raises New Compliance Hurdles for Medical Devices
The new EU Artificial Intelligence Act (AI Act, 2024/1689) adds a layer of regulatory requirements for medical device firms already
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