When registering a product in the list of aids (Hilfsmittelverzeichnis, HMV), the medical benefit of the product to be registered for the claimed product category and corresponding indication must be substantiated by qualitatively appropriate medical assessments. For this purpose, reports on case series/ observation of use by independent and recognised experts must be submitted.
The following must be submitted with the application
- Study protocol
- Evaluation protocol
- Final report of the studies
- Evaluation of the publication of the studies must be submitted.
In this context, BEO BERLIN organises and supervises all or parts of the process for companies. BEO BERLIN has extensive expertise and experience in the field of marketing authorisation for medical aids / therapeutic applices and the required evidence management and document preparation. BEO BERLIN cooperates with a wide network of assessors and institutions for carrying out user observations. Companies benefit from our expertise, experience and network in the medical device industry. This enables an efficient and successful process of list of nursing aids (Pflegehilfsmittelverzeichnis, PHMV) product listing according to Book V of the German Social Code (SGB V).
