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Steps for obtaining CE certification or CE Mark

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Guest user Created:   Aug 03, 2020 Last commented:   Aug 19, 2020

Steps for obtaining CE certification or CE Mark

WE are a manufacturer of Medical Device Face mask and PPE. We are recently certified ISO 13485 and would like to get CE certification or CE Mark
What're the steps shall we follow?
 

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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.

Expert
Kristina Zvonar Brkić Aug 19, 2020

First, you need to define under which regulation you want and can certify your medical device: MDD 93/42/EEC or MDR 2017/745. Then you need to define which class your face masks are. Rules to define it, you can find on the following links:

Then you need to prepare the Technical documentation. Which documents are necessary to be in Technical file under the MDD you can find in Annex 1. Required technical documentation under the MDR you can fin in the

After you prepare a technical file, you need either to register your device in local authority (if it is class I and do not require Notify body) or you need to certify your medical device with Notify body.

For more information about MDR, please see the following articles:

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Aug 03, 2020

Aug 19, 2020