PPWR: What changes and what to prepare by 12 August 2026
Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) repeals the Packaging Directive 94/62/EC and introduces harmonised requirements on sustainability, labelling, re-use, [...]
MDR and IVDR: the Commission updates the lists of Harmonised Standards
On 17 June 2026, the European Commission published two Implementing Decisions in the Official Journal of the European Union, updating [...]
New RECOPS platform in Spain: the medical device register integrated with EUDAMED is now operational
As announced in the AEMPS Information Note of May 2026, the new RECOPS platform (Registro de Comercialización de Productos Sanitarios) [...]
Switzerland: UDI registration in swissdamed and clarifications for Legacy Devices
As of July 1, 2026, the registration of UDI (Unique Device Identification) data for Medical Devices and procedure packs in [...]
Medical Devices in China: NMPA regulates the management of classification changes
In China, the classification of Medical Devices is subject to continuous updates across Class I, II, and III. To regulate and standardize the regulatory consequences of these changes and guide enforcement by local authorities, the National Medical Products Administration (NMPA) published Announcement No. 52/2026, effective June 1, 2026
ISO 19011:2026, What changes for Management System Audits
At the end of May 2026, the fourth edition of EN ISO 19011 was published, redefining the guidelines for conducting management system audits. Fully replacing the 2018 edition, it formalizes an ongoing operational evolution: remote auditing.
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 [...]
