MDCG published guidance on EU authorized representative requirements and their role under new MedTech regulations. The MDCG guidance 2022-16 unpacks what MDR and IVDR mean for authorized representative, manufacturers and other economic operators. Authorized representatives serve as their EU contact person and they ensure compliance with regulations. MDR and IVDR enhances their responsibilities.
The manufacturers not having presence in EU member state are required to appoint Authorized representative. They are also known as ECREP. As a CE mark medical device consultant, we help you in building a relation with authorized representative.
According to the MDCG guidance, “the manufacturer and the authorized representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties. A mandate should be drawn up irrespective of whether the authorized representative is independent/outside of or is part of the same larger organization as the manufacturer,”
As per the article 11(3) authorized representative should perform specific task with the manufacturers. As per the article certain activities cannot be delegated by the manufacturer to authorized representative.
Responsibilities of Authorized representative:
- Need to keep a copy of EU declaration of conformity.
- Assistance with some IVD and medical device is necessary
- Register in EUDAMED and update information within a week
- Check for technical documents and the EU declaration of compliance.
- be identifiable on all European product labels.
Few things to keep in mind that the manufacturers must list the name and address of the AR on the product label. Competent authority may inspect the authorized representative to check whether they understand their roles, have direct accesses to technical file /dossier have processes in place to ensure it can fulfill its role as an Authorized Representative.
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