The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79) The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55) The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17) The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10) Key Concepts of Medical Device Design Development Three Essential Steps to Getting a Device to the U.S. Market Posts navigation 1 2