EU MDR classification

The new European Regulation on Medical Devices includes in its scope new devices, previously not regulated by Directive 93/42 / EEC, thereby changin and/or better specifying the classification rules (software, borderline devices, etc.).
To prepare properly and timely, the manufacturers of medical devices must:
  • Carefully check the classification of their products
  • Make an adjustment plan for the devices to be certified or reclassified
  • Identify the standards applicable to their products
  • Identify which tests are required
The same direction must be created for products in the design phase, which must be certified immediately with respect to the new regulation.
Maytal can support you for all these activities.