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Marius Laurusevicius's avatar

There is one more place the Act names a party. Article 22 requires providers established in third countries to appoint, by written mandate, an authorised representative established in the Union before a high-risk system is made available here.

Article 22(3) makes that representative produce the mandate to market surveillance authorities on request, and verify that the EU declaration of conformity and the Article 11 technical documentation have been drawn up.

Narrow, provider-side, and silent on who owns a documented gap. But it is the one named party an authority can reach without first asking the company who to talk to.

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