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 [...]
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.
Thema srl
Via Saragat, 5
40026 Imola (BO) – Italy
Tel. +39 0542 643496
Fax. +39 0542 641833
info@complifegroup.com
Thema Corp
B+Labs c/o Cira Center
2929 Arch Street, Floor 4
Philadelphia, PA 19104 – U.S.A.
Tel. +1 215-845-9459
© Copyright Thema srl – 2024 | | All Rights Reserved – C.F./P.IVA IT02770361208 N. REA BO n.466056 | Cap. Soc.€ 50.000 i.v.
