In the MDR and IVDR, it is stated that the commission can assign a group or can establish by itself CS. In the real world, the commission delegated this task to a group of experts, the Medical Device Coordination Group (MDCG), which in fact is demanded in the MDR and IVDR. These experts in the MDCG are representing the member states and holed expertise in medical devices and in-vitro diagnostics. In fact, each member state can send a member per each expert group, i.e. medical device and in-vitro diagnostics, including a substitute. Thus, each member state can bring 4 people into the MDCG. Further, the MDCG can, on a case-by-case basis, bring in external experts and third parties for specific discussions and expert opinions. To sum up, the MDCG elaborates common specifications and the commission accepts and implements these