In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation.
D'fhonn cinntí comhsheasmhacha maidir le cáiliú a áirithiú i dtaca leis sin ar fud na mBallstát, go háirithe i dtaca le cásanna teorannacha, ba cheart don Choimisiún a bheith in ann, ar a thionscnamh féin nó ar iarraidh chuí-réasúnaithe ó Bhallstát, tar éis dul i gcomhairle leis an nGrúpa Comhordaithe maidir le Feistí Leighis (“GCFL”), cinneadh a dhéanamh, ar bhonn gach cáis faoi leith, an dtagann táirge sonrach nó catagóir nó grúpa sonrach táirgí faoi raon feidhme an Rialacháin seo nó nach dtagann.