MDR Consultation Hour

Do you have questions about the MDR and the conformity assessment process? Then you have come to the right place.

Regardless of whether you are a manufacturer or a consultant, we are regularly available to answer general questions and discuss the specific procedures of our Certification Body and Notified Body.

Manufacturer consultation hours:

MDR manufacturer consultation hours are held on Fridays from 9-10 a.m. in even calendar weeks (except holidays and week 52). You will also have the opportunity to ask questions there: MS Teams Link

Meeting transition deadlines: when do I need to report to a designated entity?
What do we start with: Management system or clinical evaluation and technical documentation?
When should I secure a place with a notified body?
When must all documentation be finalized?
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Counselor Consultation Hours:

MDR Counselor Consultation Hours are held on the fourth Friday of every odd-numbered month from 1-4 p.m. (additional appointments are available upon request). You will also have the opportunity to ask questions there: MS Teams Link

What should my clients look for when contacting a designated agency?
What information does the notified body need and when?
What information does the notified body need and for what purpose?
What is the procedure at Berlin Cert, so that I can support my customers in the best possible way?
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