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?
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?