Annex X — EU type examination
MDR 2017/745, Annex X and IVDR 2017/746, Annex X. Annex X defines the EU type examination procedure. It is used in combination with Annex XI (Part A or B) and is available for Class IIa, IIb (MDR) and Class B, C (IVDR). Not available for Class III (MDR) or Class D (IVDR), which must use Annex IX.