Manufacturers
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).
Authorised representatives (EU REPs)
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).
Importers
Importer obligations are defined in MDR Article 13 and IVDR Article 13. Definitions appear in MDR Article 2(33) and IVDR Article 2(30).
Distributors
Distributor obligations are defined in MDR Article 14 and IVDR Article 14. Definitions appear in MDR Article 2(34) and IVDR Article 2(31).
Person responsible for regulatory compliance
The PRRC requirement is established in MDR Article 15 and IVDR Article 15.