Regulatory Update- MDR 2017/745
The new EU medical device regulations (MDR 2017/745) are almost here. They will be going into effect on May 2020 and will affect all medical devices. The focus of this document is the class I self-declared devices, which are deemed Class I under MDD.
Class I Devices – must comply with the MDR by May 2020, unless the device concerned is a class I device with measurement function or in sterile condition covered by a valid MDD certificate. MDD Class I devices must be fully compliant with the MDR by May 26th, 2020. This means that the Technical File should be updated with the new MDR requirements. Annex I General Safety and Performance Requirements, and the Post-market Surveillance Report (PMSR) will be required to document the results of the post-market surveillance for each device.
Class I Reusable – The MDR defines a reusable surgical instrument as “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.” (MDR 2017/745 Annex VIII, Chapter I, Section 2.3).
The new classification for reusable medical devices will require a notified body, and many medical devices will be reclassified to this higher risk class. Medical devices placed on the market after May 25, 2020, must follow the MDR. Reusable surgical instruments will no longer be self-certified Class I devices but will be deemed as “Class IR”. Class IR medical devices will require a conformity assessment procedure with a Notified Body and will be labeled with the number of the Notified Body, like currently class I sterile devices are. The Notified Body will review the cleaning instructions, disinfection, sterilization, maintenance, functional testing and associated validations. For more information, see Article 52 of the MDR.
Class I Software – A special rule for software, rule 11 of 2017/745/UE Medical Device Regulation (MDR), now classifies some of the standalone & also embedded software as class IIa. Most software as a medical device (SaMD) will be reclassified from Class I to Class IIa medical device and will require the establishment of a full quality system and conformity assessment by a Notified Body. This means that a valid CE-Mark Certificate issued by a Notified Body must be in place at latest in 26th May 2020. Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes will now go from class I up to class IIa, IIb or III. The new rule for SW classification, Rule 11, reads as follows:
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
- death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
- a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software is classified as class I.