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.
On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the sixth [...]
It examines the most common non-conformities identified by Notified Bodies during audits and assessments, offering practical solutions to prevent and effectively manage them.
On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable fillers, [...]
In recent months, the regulatory framework governing the biological safety of Medical Devices has undergone a significant evolution. With the [...]
On 5 May 2026, Commission Implementing Regulation (EU) 2026/977 was published, introducing a harmonised framework of quality and procedural requirements [...]
EUDAMED is the European Union's online database for Medical Devices. It serves as a centralized system where: Manufacturers register their [...]
Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant interpretative [...]
Translated with AI. On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of the [...]
Translated with AIOn April 1, 2026, Health Canada published the “Guidance on terms and conditions for class II to IV Medical [...]
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