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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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Meet us!

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We are back at REHACARE this September. Set up a meeting and visit us at our "mobile office" or at our workshop on Friday, 28th!

 

 

 

 

BEO News

Tuesday, 10. July 2018

Revision of the Waste of Electrical and Electronic Equipment Act (WEEE) in Germany and Europe 2018

The German Elektrogesetz is the implementation of the European WEEE Directive (Waste of Electrical and Electronic... Read more >>

Wednesday, 20. June 2018

Updates in the German Reimbursement List (HMV), trends and feedback from the market - June 2018

In the past, we have sporadically written about the update of theHealth and Medical-Aid Supply Law(HHVG) ... 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.