UDI in China: from 1 June 2027, requirements extended to Class II devices and Class I IVDs
From 1 June 2027, UDI requirements in China will be extended to all Class II Medical Devices (including Class II [...]
Brazil: ANVISA Clarifies Market Access Pathways for Medical Devices and IVDs
At the end of August 2026, ANVISA published two guidance manuals dedicated to the regularization of Medical Devices on the [...]
USA: FDA Pre-Market Recommendations for Buffy Coat Blood Collection Systems and Dental Composite Resin Devices
In September 2026, the US FDA finalized two guidance documents for manufacturers of specific Medical Devices: "Recommendations for the Development [...]
MDCG 2020-16 Rev. 5: Rule 7 and the Classification of IVD Controls Without Assigned Values
On 9 September 2026, the Medical Device Coordination Group (MDCG) published Revision 5 of the guidance document MDCG 2020-16 [...]
PCCPs and Medical Device Software: IMDRF Essential Principles for Planned Modifications
The evolution of medical device software presents a growing challenge for regulators and manufacturers: how to enable the continuous update [...]
IVDR: countdown to September 26 for Class C Legacy IVDs
September 26, 2026, is approaching fast - a critical deadline for the continuity on the EU market of Class C [...]
MDSAP Audit Approach Rev. 11: Key Changes and Impact on Manufacturers’ QMS
On August 3, 2026, Revision 11 of the MDSAP Audit Approach (AU P0002.011) was published. This document serves as the [...]
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 [...]
