The new EU Medical Device Regulations, which are due to be voted on by the European Parliament, will result in increased post market surveillance and vigilance requirements for medical device manufacturers. One of the new requirements in the field of vigilance reporting is the periodic safety update report ( PSUR ).
Manufacturers of class IIa, IIb and III devices along with manufacturers of class C and D IVD devices will now need to complete and maintain a PSUR for each device or category/group of devices that they manufacture. Companies must now be prepared to update their technical file to include PSURs.
INFORMATION TO BE INCLUDED IN THE PSUR
Similar to the PSUR for medicinal products, these reports will summarise post-market surveillance data and describe any preventive and corrective actions taken during that period in relation to the device(s). For instance, the PSUR must include information on:
the benefit-risk analysis for the devices; the main findings of the post-market clinical follow-up; the volume of sales of devices; an estimate of the size and other characteristics of the population using the device; and where practicable, the usage frequency of the device. FREQUENCY AND SUBMISSION PROCEDURE
CLASS OF DEVICE FREQUENCY METHOD OF SUBMISSION Class IIa At least every 2 years and earlier if necessary Make available to notified bodies and, on request, to competent authorities Class IIb Annually Make available to notified bodies and, on request, to competent authorities Class III Annually Upload onto Eudamed Class C IVD Annually Make available to...