Year 8 · AEDTH

MDR-08-01

Contract phantom manufacture

تصنيع أشباح بالتعاقد

Roadmap — not an offer

Make for others. Contract phantoms for national firms. One CE-intent technical file, not a CE mark.

MEDRA casts or prints training phantoms to a firm’s drawing, under their label rules and MEDRA’s batch record.

Regulatory posture
Not a medical device. For planning, rehearsal or training. Not for diagnosis or implantation.
Who it is for
Egyptian device manufacturers
Kind
Service
Limit
Training goods unless the firm holds the device registration.

What is in the line

  • Batch
  • Record
  • Deviation