Evnia’s certifiedย Authorized Representative operational branch, built upon our long regulatory experience, guarantees that manufacturers outside ofย Europe have a trusted partner of high professional courtesy to act as their liaison with European Competent Authorities.
Browse our brochure for more information:
๐ฅ๐ฒ๐บ๐ฒ๐บ๐ฏ๐ฒ๐ฟ
๐๐๐ฆ๐จ๐ข๐ญ ๐ฎ๐ข๐ฏ๐ถ๐ง๐ข๐ค๐ต๐ถ๐ณ๐ฆ๐ณ๐ด ๐ธ๐ช๐ต๐ฉ ๐ฏ๐ฐ ๐ฑ๐ฉ๐บ๐ด๐ช๐ค๐ข๐ญ ๐ค๐ฐ๐ฎ๐ฑ๐ข๐ฏ๐บ ๐ญ๐ฐ๐ค๐ข๐ต๐ช๐ฐ๐ฏ ๐ธ๐ช๐ต๐ฉ๐ช๐ฏ ๐๐ ๐ฎ๐ฆ๐ฎ๐ฃ๐ฆ๐ณ ๐ด๐ต๐ข๐ต๐ฆ๐ด ๐ญ๐ฐ๐ฐ๐ฌ๐ช๐ฏ๐จ ๐ต๐ฐ ๐๐ ๐ฎ๐ข๐ณ๐ฌ ๐ฎ๐ฆ๐ฅ๐ช๐ค๐ข๐ญ ๐ฅ๐ฆ๐ท๐ช๐ค๐ฆ๐ด ๐ถ๐ฏ๐ฅ๐ฆ๐ณ ๐๐๐ ๐ฐ๐ณ ๐๐๐๐ ๐ฎ๐ถ๐ด๐ต ๐ฅ๐ฆ๐ด๐ช๐จ๐ฏ๐ข๐ต๐ฆ ๐ข๐ฏ ๐๐๐๐.ย
๐The EUAR is a ๐๐ง๐๐ฉ๐๐๐๐ก ๐จ๐ช๐ฅ๐ฅ๐ก๐๐๐ง, which ensures the continuity of a productโs availability in Europe.ย Its selection should be careful.
๐Apart from the potential joint liability upon the manufacturerโs failure to comply with its obligations, the EUAR should
โ๏ธbe able to represent the Manufacturer adequately and answer all questions from the Competent Authorities;
โ๏ธhave permanent and continuous access to a person responsible for regulatory compliance;
โ๏ธhave the know-how for audit support, v#igilance reporting, and regular compliance checks;
If you need EUAR services or advice and support with understanding the MDR /IVDR requirements for economic operators, reach out toย Envรญa today!
Contact us at info@evnia-ar.com.
