To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable devices should be in the highest risk class.
Chun go gcoinneofar an leibhéal céanna sábháilteachta leis an leibhéal dá bhforáiltear i dTreoir 90/385/CEE, ba cheart feistí so-ionchlannaithe gníomhacha a bheith san aicme is airde riosca.