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Category: MDR

Technical Documentation Requirements under the MDR – a Case Study

January 14, 2019

by Michael Sander

You may already have asked yourself how Regulation (EU) 2017/745 on medical devices (MDR) affects the Technical Documentation requirements for your products. This is a very complex question and cannot be… Read More

Filed under CE Marking, MDR

Tagged Case Study, MDR

Notified Body Selection and Change

December 15, 2018

by Michael Sander

mdi Europa EU Authorized Representative guides through compliance processes and regulatory affairs

Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More

Filed under CE Consulting, IVDR, MDR

Tagged AIMDD, IVDD, IVDR, MDD, MDR, Notified Body

Important facts about mdi Europa

mdi Europa was founded in 2000 to provide high quality regulatory affairs services for medical devices and in vitro diagnostics worldwide.
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distributors

Our high quality compliance solutions, as confirmed by our ISO 9001:2015 certification include:

classification
identification of EU standards
Technical Documentation compilation and review
product registration to national EU authorities
labeling compliance
Free Sales Certificates
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Category: MDR

Technical Documentation Requirements under the MDR – a Case Study

Notified Body Selection and Change

News on EUDAMED

DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR

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