In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements, and the requirements for clinical investigations and clinical evaluation and/or post-market clinical follow-up, laid down in this Regulation.
I réimsí nach bhfuil caighdeáin chomhchuibhithe ann nó nach leor iad, ba cheart a thabhairt de chumhacht don Choimisiún sonraíochtaí comhchoiteanna a leagan síos a thabharfadh caoi na ceanglais ghinearálta sábháilteachta agus feidhmíochta agus na ceanglais maidir le himscrúduithe cliniciúla agus meastóireacht chliniciúil, agus/nó bearta leantacha cliniciúla iarmhargaidh, a leagtar síos sa Rialachán seo, a chomhlíonadh.