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CE mark

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Medical device manufacturers have to comply with EU legislation. For CE marking and the respective conformity assessment, the Medical Device Directive 93/42/EEC is still valid until 2020. Nevertheless, manufacturers need to prepare for the requirements of the Medical Device Regulation 2014/745/EU.

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EU-Representative

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Non-European medical-device manufacturers are required to designate a single Authorized Representative. You can choose BEO BERLIN® to be your representative.

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Reimbursement

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For reimbursement in Germany, home-care products need to be registered in the so-called Hilfsmittelverzeichnis (German Health Aid List). 

Feel free to contact us for more information.

 

 

 

 

BEO News

Monday, 17. June 2019

Reimbursement of Health Apps

According to the notion of the Federal Ministry of Health (BMfG), in future patients should be... Read more >>

Tuesday, 14. May 2019

Update of the Product Group 17: Aids for Compression Therapy

The first major update wave was completed at the end of 2018. The effects in the individual... Read more >>

Welcome to our website

We gladly advise you on questions about medical-device testing and registration. We support you with CE file preparation, with product registration in national reimbursement systems or in the establishment of a quality management system.

Due to our long-term experience and competent specialist team, BEO BERLIN® can contribute to an accelerated health-care market entry of your device. We are proud to assist more than 250 product registrations in the German Health Aid List annually.

Seminars on health care topics, on the medical device law and the German Health Aid List (Hilfsmittelverzeichnis – HMV) complement our service portfolio.
Consider BEO BERLIN® as your external department for questions in the health-care market: national reimbursement registration, CE and QM system according to ISO 9001 and ISO 13485. We offer high-quality, customer-oriented solutions for transparent and fair prices.