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EU Authorized Representative for a Class I Medical Device

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Mikilk

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1) In order to be able to put the CE on your product label (Class I device) according to the MDD you need to have full Technical file, a contract with EU based company to act as your EU authorized representative, and a process of registration in the Competent Authority where your EU rep based.

2) Aiming to the MDR - that should be fully implemented by May 2021 (after 1 year of delay due to Covid19 situation), you need to upgrade your technical file to include the requirement of the MDR 2017/745 requirements (annex II - Technical Documentation + Annex III PMS activities) and you also must implement a quality system that will meet the MDR requirements.

In order to accomplish the above-mentioned tasks, the manufacturer will carry out the following:
- Put in place a quality management system and a system for risk management according to Article 10(2) and 10(9).
- Conduct a clinical evaluation in accordance with Article 61, as established in Article 10(3) and Annex XV.
- Draw up and keep up-to-date technical documentation related to devices as set out in Annexes II
and III, in accordance with Article 10(4).
- work with the EUDAMED database and load the required information
- control over the EU economic operators (importers, distributors, EU authorized reps)
- have the UDI-DI number

and many additional obligations.

your EU reps will need to have a copy of your Technical file & in the near future the technical documentation that meets Annex II+III of the MDR.

Please also read the MDCG 2019-15 - GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
 
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