Monsoon Jet Ventilator Accessories Update

27 August 2024

We are aware that many of the Monsoon Jet Ventilator accessories have been unavailable throughout 2024 pending the manufacturers being awarded the Medical Device Regulations (MDR) certificate. We recently wrote to both MHRA and Inspiration Healthcare to support this process, which has taken longer than expected.

We are pleased to report that Inspiration Healthcare have recently contacted us to inform that the manufacturers have applied to the MHRA for a derogation while they await the final approval of MDR. This has been granted and the derogation is in place until 25th January 2025. To confirm, the lack of availability of these items is linked to the transition from the Medical Device Directive to the Medical Device Regulations; there have been no patient safety issues raised nor any change in the intended use for the products concerned.

The full derogation can be read here.

If you have any questions or concerns, please contact Simon Motley at +44 (0)781 297 6246 or simon.motley@inspiration-healthcare.com.