10 things you didn’t know about MDR
The word ”safety” appears 290 times in the MDR. The MDD, by comparison, uses it only 40 times.
The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).
Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations. These will require careful review, planning and updating to re-implement in compliance with the new requirements.
The definition of Medical Device will be broadened to include non-medical and cosmetic devices not previously regulated. Examples include products for cleaning, disinfection or sterilization of devices as well as contact lenses, liposuction equipment, or epilation lasers.
The new rules will require most companies to update clinical data, technical documentation, and labeling.
Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims.
Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.
Reclassification of many Medical Devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.
IVDs are now classified into four risk classes that will require notified body review for about 90% of the devices, up from the current 10%.
Class I full QMS covering all areas.