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EU MDR Compliance (In Progress)

roclub has submitted technical documentation under the Medical Device Regulation (EU) 2017/745, with CE marking pending.

  • MDR Annex II and III compliant technical documentation
  • Ongoing conformity assessment by Notified Body (SIQ)
  • Post-Market Surveillance Plan, Periodic Safety Update Reports, and Clinical Evaluation Reports implemented

rTOP is classified as a Class IIa software medical device under Rule 11 of MDR Annex VIII.