As of 1 December 2025 new validation criteria v8.2 for eCTD submissions are mandatory.

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 47122/25

Product group In-vitro diagnostics - immunological products
Reference 47374/25

Product group Medical instruments for use in humans - general instruments
Reference 46212/25

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 46806/25

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 45672/25

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 46254/25

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 45282/25

Product group Non-active implants - bone surgery
Reference 47243/25

Product group In-vitro diagnostics - immunological products
Reference 46929/25

Information on the change of marketing authorisation holder were added.

Product group In-vitro diagnostics - immunological products
Reference 46265/25

Product group Medical instruments for use in humans - bone surgery
Reference 46956/25

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 26421/24

Information on the change of marketing authorisation holder were added.

Product group Active implantable medical devices - artificial hearts
Reference 47997/25

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 47553/25

Active substance: caspofungin The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.

Product group Optics / Precision engineering - endoscopes
Reference 47215/25

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 46240/25