To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence.
Chun ardleibhéal sábháilteachta agus feidhmíochta a áirithiú, ba cheart cruthú chomhlíonadh na gceanglas ginearálta sábháilteachta agus feidhmíochta a leagtar síos sa Rialachán seo a bheith bunaithe ar fhianaise chliniciúil.