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


