Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in moderate and high risk classes, the manufacturer must involve a designated/notified body, which will issue a certificate following a successful conformity assessment procedure.
A certification gap arises if a certificate issued under the old legislation as per Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) expires before the required certificate has been issued under the new regulation (MDR)…
