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Replacement for Directive 93/42/EEC

ISO 13485 & EU MDR
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Guest user Created:   May 31, 2021 Last commented:   Jun 02, 2021

Replacement for Directive 93/42/EEC

ISO 13485 & EU MDR
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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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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

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