LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Devices Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021. The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement.
LONDON – The European Commission has published new guidelines on cybersecurity for medical devices, putting flesh on the bones of the requirements in the Medical Devices Regulation (MDR) that comes into force in May.
The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Devices Regulation (MDR) when it comes into force on May 26, 2020. Consequently, manufacturers of reusable surgical instruments and devices that have a measuring function will have an additional four years to meet the stricter requirements of MDR.