6 docs tagged with "economic-operators"

EU REP obligations are defined in MDR Article 11 and IVDR Article 11. Definitions appear in MDR Article 2(32) and IVDR Article 2(29).

Distributor obligations are defined in MDR Article 14 and IVDR Article 14. Definitions appear in MDR Article 2(34) and IVDR Article 2(31).

Importer obligations are defined in MDR Article 13 and IVDR Article 13. Definitions appear in MDR Article 2(33) and IVDR Article 2(30).

MDR Article 10 and IVDR Article 10 set out the general obligations of manufacturers. Definitions appear in MDR Article 2(30) and IVDR Article 2(27).

The PRRC requirement is established in MDR Article 15 and IVDR Article 15.

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)