The classification had to be reviewed from a class I to a class IIa device according to Rule 20 of MDR.
Rule 20 says:
„All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat lifethreatening conditions, in which case they are classified as class IIb.“
As already reported, more notified bodies are expected to be designated by the end of the year. A heavy workload awaits them as the timeline of the MDR is tight.
The BSI is now focused on the first batch of MDR reviews to be compliant with the new EU requirements. As Gary Slack, Senior Vice-President of the notified body at BSI states :
„The transition to the MDR is a significant challenge to the medical device industry as a whole. […] The increased requirements on manufacturers and notified bodies means the BSI team is experiencing increased pressure to meet the new regulatory assessments.“
BSI: Press release