Important notices

1. NEW terms and conditions and the method of recognition of foreign documents on conformity (Declaration of Conformity) in procedures conducted before the Agency – harmonization of national regulations due to the transition of EU directives (MDD/AIMD) to EU regulation (MDR)

2. NEW terms and conditions and method of recognition of foreign certificates of conformity of medical devices (EC certificate) in procedures conducted before the Agency – harmonization of national regulations due to the transition of EU directives (MDD/AIMD) to EU regulations (MDR)

3. NEW terms and conditions and method of recognition of foreign documents on conformity (Declaration of Conformity) in procedures conducted before the Agency – harmonization of national regulations due to the transition of the EU directive (IVDD) to the EU regulation (IVDR)

4. NEW terms and conditions and method of recognition of foreign certificates of conformity of medical devices (EC certificate) in procedures conducted before the Agency – harmonization of national regulations due to the transition of the EU directive (IVDD) to the EU regulation (IVDR)