Poland Authorized Representative

It follows EU MDR.

Obligations of Authorized Representatives

1. A manufacturer designates an authorized representative, an entity located in a Member State, to fulfill regulatory obligations on their behalf.
2. An authorized representative based in Poland notifies the President of the Office at least 14 days before introducing a device to the market or initiating the evaluation process.
3. Manufacturers without a presence in a Member State appoint an authorized representative responsible for ensuring product conformity assessment and market placement.