It has obligations such as record keeping, reporting and handling of products through the following four corporations designated as Economic Operators under the European Medical Device Regulations (EU MDR).
- Manufacturers
- Importers
- Distributors
- Authorized representatives
However, manufacturers that are not located in the EU require authorized representatives.
As such, MDCG 2019-5 rev.1 outlines the requirements applicable to products as guidelines for Class I medical device manufacturers, indicating that non-EU manufacturers must appoint authorized agents to EU member states before launching all Class I products.
Authorized Representative is a natural person or corporation in the EC region who is clearly appointed by the manufacturer to act on behalf of the manufacturer in respect of the manufacturer's obligations in this directive and to be contacted by the EC authorities and certification authorities.
Also Authorized representatives must write their names and addresses together with the EC REP logo in labeling and packaging.
If you have any questions about the guidelines for Class I medical device manufacturers, please refer to the file below.
To learn more about the role of authorized representatives, please refer to Article 11 of CHAPTER II in MDR regulations below.
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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