This White Paper is intended as a guide to support manufacturers of in vitro diagnostic Medical Devices in the correct application of Regulation (EU) 2017/746 (IVDR) and in the preparation and management of the technical documentation.
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, recyclability, [...]
On 17 June 2026, the European Commission published two Implementing Decisions in the Official Journal of the European Union, updating the [...]
As announced in the AEMPS Information Note of May 2026, the new RECOPS platform (Registro de Comercialización de Productos Sanitarios) has [...]
The biocompatibility of Medical Devices is the ability of a device to interact with the human body without causing unacceptable biological [...]
As of July 1, 2026, the registration of UDI (Unique Device Identification) data for Medical Devices and procedure packs in the [...]
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
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.
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