In order to simplify the administrative procedure for radiation applications subject to notification in accordance with Section 32 of the Radiation Protection Act (StrlSchG) in the context of clinical investigations pursuant to the Medicinal Products Act (AMG) or Regulation (EU) 2017/745 on medical devices (MDR), a change of responsibility will take effect on 1 July 2025.

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 27519/25

Active substance: misoprostol Reminder of the authorisation-compliant application.

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 25922/25

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

Product group Physical therapy - massage / mobility devices
Reference 22888/25

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

Product group In-vitro diagnostics - immunological products
Reference 27353/25

New guidelines have been added

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

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

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 24423/25

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 25741/25

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

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.

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.

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