FDA partially recognizes ISO 10993-1:2025: what changes for Biocompatibility
On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the [...]
Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution
On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable [...]
Biocompatibility and biological safety of Medical Devices: what’s new in ISO Standards 2025 – 2026
In recent months, the regulatory framework governing the biological safety of Medical Devices has undergone a significant evolution. With [...]
Regulation (EU) 2026/977: new rules for Notified Bodies on timelines, costs and procedures
On 5 May 2026, Commission Implementing Regulation (EU) 2026/977 was published, introducing a harmonised framework of quality and procedural [...]
MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification
Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant [...]
What to do in case of interruption or discontinuation of medical device supply?The Commission clarifies with a Decision Tree and updated FAQs
Translated with AI. On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of [...]
Health Canada: New Operational Guidance on Terms and Conditions (T&Cs) for Class II–IV Medical Devices
Translated with AIOn April 1, 2026, Health Canada published the “Guidance on terms and conditions for class II to IV [...]
Two Delegated EU Regulations expand the MDR WET List
Translated with AI On March 20, 2026, the European Commission adopted two delegated regulations, C (2026) 1809 and C (2026) [...]
Medical Device Labelling Rules in Malaysia: what is changing
Translated with AI In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document "Requirements [...]
Australia UDI Guide V2.0: how to properly prepare for deadlines
Translated with AIIn February 2026, the Australian Therapeutic Goods Administration (TGA) published version 2.0 of the official guide: "Complying with [...]
MDSAP: Audit Approach Version 010 Released, what changes
On February 2, 2026, version 010 of the MDSAP AU P0002 – Audit Approach manual was released. This update comes [...]
Compliance Program 7382.850: what to expect from the new FDA inspections
On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves [...]
South Korea launches fast track pathway for innovative Medical Devices
On 26 January 2026, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) [...]
Regulation B.E. 2568 in Thailand: A Unified Framework for Medical Device Labeling
Translated with AI The regulatory framework for medical device labelling in Thailand reached a comprehensive synthesis with the publication of [...]
Clinical Decision Support Software: FDA Guidance Provides Clarity
Translated with AI The evolution of digital health has blurred the lines between IT tools and Medical Devices. A key [...]
MDR and IVDR Reform: the Commission’s Proposal for a Long-Awaited Simplification
Translated with AI With the publication of the proposal for a Regulation COM(2025) 1023 final of 16 December 2025, the [...]
TGA updates the guidance on Essential Principles for Medical Devices
Translated with AI On November 19, 2025, the Therapeutic Goods Administration (TGA) released the updated guidance "Complying with the [...]
Breakthrough Devices (BtX): New Opportunities for MedTech Innovation in Europe
Translated with AI On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on “Breakthrough Devices (BtX)”. [...]
