Medical Certificate Approval

Roam Technology Successfully Achieves MDR Approval

Roam Technology has successfully completed the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR – EU 2017/745), achieving MDR approval for its medical device product families.
3 December 2024
Huwa-San Dent Combi Packshots

Medical Device Directive

Roam Technology NV mainly produces biocides for several application areas, however they are also legal manufacturer of a few medical device families. Medical devices were previously regulated under the Medical Device Directive (Directive 93/42/EEC) in which Roam Technology NV had approvals for:

  • Dental Unit Water Line Disinfectants (Huwa-San DENT):
    • Huwa-San DENT PL
    • Huwa-San DENT P
    • Huwa-San DENT 6
Huwa-San MD packshots combi
  • Disinfectants for non-invasive medical devices (Huwa-San MD):
    • Huwa-San 3 MD
    • Huwa-San 5 MD
    • Huwa-San 7,9 MD
    • Huwa-San 12,5 MD

All products were classified as class IIa medical devices under the Medical Device Directive.

Medical Device Regulation

In 2017, the Medical Device Regulation (EU 2017/745) was set to replace the Medical Device Directive, introducing a transitional period. That same year, Roam Technology began preparing GAP analyses (a screening to check compliance with this Regulation) for its medical device families to gain better insight into deficiencies in both the Quality Management System and the Technical Documentation. This in close collaboration with a consultant.

The latest MDR transition deadline was set for 24 May 2024, but one of the Medical Device Coordination Group members (experts representing competent authorities of the EU countries) stated that MDD certified medical devices (also called ‘legacy devices’) were allowed to remain on the market longer if certain requirements were met. Therefore Roam Technology has received an extension letter stating that both medical device families were approved until December 31th 2028 under MDD.

MDR approval timeline Roam Technology

However, Roam Technology decided to initiate the MDR transition earlier, and an agreement with the Notified Body was signed in November 2023. QMS audits and the Technical File Reviews took place in several stages in 2024. After resolving all major issues related to the QMS in July 2024, a new ISO 13485:2016* certificate has been granted . Finally, after closing all pending topics related to the Technical Documentation, Roam Technology NV received the MDR* (BE24/00000255) approval for all medical device families.

*

Exceptional MDR Approval Process

While the typical process for obtaining official MDR approval takes at least 15-18 months from the time the agreement is signed. Roam Technology achieved MDR approval in just 10 months – a remarkable accomplishment. Roam Technology’s ability to speed up this process reflects our focus on product performance and quality, regulatory compliance, and patient safety.

As from November, Dennis Lecis (Regulatory Affairs & QSHE Manager), will take on the role of PRRC (Person Responsible for Regulatory Compliance). He will make sure all medical devices comply with the Regulation and the internal procedures. Dennis recently obtained his certificate to be able to take on this new role.

All certificates can be found in the database of EUDAMED.