IMPORTANT CUSTOMER NOTICE
Dear PulseGuard customer
It is with great regret, that due to a change in classification by the MHRA following the UK leaving the EU, the Medicine Health and Regulatory Body (MHRA) are insisting that the PulseGuard seizure monitor be classified as a Class 2b medical device, instead of its current class 1 category, therefore PulseGuard International Ltd has no option other than to put the company into Liquidation.
Brexit has had a devastating impact on the Medical Device industry as well as Covid. There has been a transition from the old EU Medical Device Directive (MDD) to the new EU Medical Device Regulation. Due to Covid many of the Notified Bodies have still to be approved by the EU to monitor and approve devices. This has left a 2-year limbo for regulations. In the new regulations, the classifications for the PulseGuard device have moved from Self-Regulation (Class I) to the new Class IIb status that requires ‘Notified Body’ review and approval. With no NBs available for the last two years due to the lack of ability to audit due to Covid, everything has been delayed.
In addition, Brexit has changed the position that we now have new UKCA marks for the UK. The MHRA have gone back to old regulations and have decided to interpret what they want to do with no ability to appeal.
These changes have been devastating for the Medical Device industry. There are many manufacturers who are unable to continue or invest into the new requirements.
What this means to you: –
This means that customers that pay a monthly software subscription, will not have their licences renewed from the 1st of December and that they should arrange for an alternative method of monitoring as soon as possible, as your PulseGuard system will time out sometime during December and stop working.
The staff and directors of PulseGuard international Ltd deeply regret having to take this action but after extensive negotiations, the MHRA are unwilling to move on their decision. PulseGuard has been proud to have helped 100’s of families around the world for the last 10 years and thank you for being part of our family.
Please address any queries to Augusta Kent Limited, The Clocktower, Clocktower Square, St George’s Street, Canterbury, Kent CT1 2LE
Wishing you and your family all the best for the future.
PulseGuard Board of Directors