April 3, 2023

EU MDR Article 22 Statement vs. Article 19 Declaration

Because an EU MDR Article 22 system or procedure pack Statement of Compatibility (SoC) has a different legislative purpose than the Article 19 Declarations of Conformity (DoC) for the components inside the system or procedure pack, then the SoC and DoC need to be prepared separately in order to avoid legislative mishaps.  For an example of an Article 22 SoC, my opinion is that Article 22(2) already contains a sufficient boilerplate.