Additional clarity on the status of low-risk medical devices has provided further reassurance to manufacturers that patient access will not be unduly inhibited by the introduction of the MDR.
MedTech Europe reports that the European Union (EU) has clarified the Medical Devices Regulation (MDR) to specify that low-risk devices (including scalpels and tools for orthopaedic surgery) which comply with current rules will continue to be available for a transition period as Europe brings in new MDR arrangements.
MedTech Europe said:
“This measure ensures that devices remain available to patients, provided that these devices are lawfully CE marked before 26 May 2020, in accordance with the rules of the current Medical Device Directive. By no later than 26 May 2024, these devices must be fully transitioned to the new rules, which include the requirement for certification by a Notified Body. This facilitates the transition to the new Regulation with minimal disruption for patients and healthcare systems while the new regulatory system is still being built.”