MDR classification

Intensive care ventilators are Active device intended for diagnosis and monitoring, and they are classified to class IIb according to rule 10:

• if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance, variations in cardiac performance, respiration, the activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Rule 22 is not applicable for intensive care ventilators.

Classification rule you can find on the following link:

• EU MDR Annex 8 – Classification rules - https://advisera.com/13485academy/mdr/classification-rules/

Thank you so much. one additional question, Meddev 2.4/1 has been explained that "lung ventilators" are an example of rules 9 and 10 based on MDD. Since definitions have not changed anymore in MDR, how we can justify this issue that rule 9 is not applicable?

Thanks in advance

Rule 9 is considering active therapeutic devices s intended to administer or exchange energy, while lung ventilators are monitoring devices. According to the MDR, active monitoring devices of vital physiological processes are covered in Rule 10.