Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 23851/25

Product group Optics / Precision engineering - endoscopes
Reference 23726/25

New guidelines have been added

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 22788/25

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 24423/25

Product group ophthalmological technology - contact lenses
Reference 26223/25

Product group Medical data processing (software) - Facette_Produktgruppe_09md-07
Reference 27257/25

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 27308/25

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 25741/25

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 24215/25

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.

OPS is an adaptation of the English-language International Classification of Procedures in Medicine (ICPM) by WHO. The German version of the ICPM resulted from the translation and expansion of the Dutch version ICPM-DE (Dutch Extension) and was further developed into OPS-301 and then OPS. The OPS is currently updated annually. The alphabetical index is updated according to changes in the classification system.

ICD-10-GM is a version of ICD-10-WHO adapted to the specific requirements of the German health care system and is continuously developed. The Alphabetical Index to ICD-10-GM has developed from the ICD diagnostic thesaurus of the Central Research Institute of Ambulatory Health Care in Germany (Zi). It is adapted according to the changes to the Tabular List.

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 36336/24

Product group Active implantable medical devices - defibrillators
Reference 26815/25

Product group Medical instruments for use in humans - visceral surgery
Reference 23237/25

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 22277/25

Active substance: sodium oxybate The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.