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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 Medica this November. We are offering half-hour consultation (non-binding and free of charge!) on the new requirements of the Medical Device Regulation 2017/745 /EU us. Feel free to contact us for an appointment if you have specific questions about the implementation or you are facing a specific problem. 

 

 

 

 

 

BEO News

Wednesday, 24. October 2018

Health and Medical-Aid Supply Law (HHVG)

Since April 2017, the Health and Medical-Aid Supply Law (HHVG) has come into force. The core... Read more >>

Tuesday, 23. October 2018

Rehacare 2018 - BEO BERLIN’s review

This year's Rehacare was the biggest since the beginning of this industry gathering with exhibitor participation... 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.