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Replacement for Directive 93/42/EEC
According to MDR 2017/745 - which kind of certification will replace Directive 93/42/EEC?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jun 02, 2021
Each manufacturer that produces medical devices under the MDR will have an audit and if he can prove to the notified body that his medical device is in compliance with MDR 2017/745, then notify body will issue a certificate. After this certificate, the manufacturer will be allowed to place a CE mark on the medical device.
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May 31, 2021
Jun 02, 2021
Jun 02, 2021