NSAI issues first certificate under the new EU Medical Device Regulations to Limerick start-up Class Medical
The National Standards Authority (NSAI) certified the Limerick company’s patent-protected TUC Safety Valve which helps to prevent painful and costly patient catheterisation injuries.
Class Medical has become the first company to be certified by the NSAI under the rigorous new EU Medical Device Regulations (MDR). The newly certified device is an innovative technology aimed at eliminating problems associated with the treatment of patients that require transurethral catheterisation (TUC). TUC, which is the most common method of bladder drainage, is notorious for its risk of urethral injury, estimated to be 1100 injuries annually in Ireland alone.
The Irish medical device company, spun out of the University of Limerick and supported by Enterprise Ireland, has undergone a rigorous auditing and product conformity assessment review process over the last six months in order to ensure the TUC Safety Valve could be approved according to Dr Rory Mooney, co-founder and CTO of Class Medical.
Dr Mooney said: “This is a huge milestone for Class Medical. The TUC Safety Valve is the first device in 80 years manufactured to address the problem of transurethral catheterisation injury. Becoming the first company to get the seal of approval from NSAI under the MDR is absolutely fantastic.”
NSAI was approved for designation to the new MDR in February 2020, making it the only Notified Body in Ireland allowed to approve such products. Putting the regulatory organisation amongst an elite group of certifying bodies worldwide to achieve this designation, NSAI can ensure continued access to the European medical devices market for its clients.
NSAI Head of Medical Devices, Dr Caroline Dore Geraghty, highlighted the fact that the first certificate issued by NSAI under the new MDR was to an Irish company, making the process extra special.
Dr Dore Geraghty said: “The NSAI medical devices team is thrilled to issue the first certificate under the Medical Devices Regulation to this indigenous Irish company, we look forward to working with Class Medical into the future. Well done to Class Medical and to the NSAI medical devices team who worked tirelessly to make this happen during the pandemic.”
Class Medical, which was recently named ‘Best Catheter Safety Device Development Specialist 2021’ by the Irish Enterprise Awards, will begin a new pilot programme with Irish hospitals in April in an effort to alleviate the pressure on the healthcare system which has been under a huge amount of stress due to COVID-19. The TUC Safety Device will reduce the number of catheterisation injuries thereby freeing up much-needed beds in hospitals across the country.
Dr Hugh Flood, Consultant Urologist and Class Medical CMO, said: “The Class Medical TUC Safety Valve makes urethral catheterisation much safer and prevents vulnerable patients from being seriously and painfully injured. We are delighted to be the first company to be certified by NSAI under the new regulations and look forward to seeing our device make a real difference for both patients and medical professionals.”
NSAI Head of Medical Devices, Dr Caroline Dore Geraghty, and Class Medical CMO, Dr. Hugh Flood are both available for interview.
Media Enquiries
For NSAI media enquiries please contact Deirdre Farrelly, PR Account Manager.
e: deirdre.farrelly@nsai.ie
t: 086 869 0774
Notes to the Editor
About NSAI Medical Devices
NSAI offers a full range of services relating to Management System Standards and Certification Services for medical device manufacturers. The Medical Devices division is one of the fastest growing areas within the NSAI. The organisation is authorised for MDSAP through NSAI Inc which has brought strong growth in certification activity. The new designation to MDR will allow NSAI to service both the national and international market in the MedTech sector.
Class Medical Milestones
2016: Completed positive Cost Benefit Analysis of Urethral Catheterisation in two Irish Hospitals
2017: ‘First-in-Man’ study of 100 patients using the TUC Safety Valve during urethral catheterisation
2018: Human clinical study completed and published
2019: Follow-up to 2016 study published in World Journal of Urology
2020: CE approval process initiated
Prospective study
2021: Certified by NSAI under new EU Medical Device Regulations (MDR)
Product ready for commercial sale April 2021
Free in-hospital clinical study April 2021
