Custom-made medical device
A medical device made for one patient's sole use.
Last updated
A custom-made medical device (CMD) is a medical device designed and manufactured for the sole use of a particular patient. Examples include auricular splints, dentures, orthodontic appliances, orthotics, and prostheses. The device is made to meet the specific needs of that individual patient.
Quick Facts
- Canada regulation
- Part 2 of the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act
- Eu regulation
- Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR])
- Eu mdr publication date
- 5 April 2017
- Australia record retention period
- at least five years
Facts from the source article.
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Sources
Compiled from Wikipedia and the sources listed below. Text from Wikipedia is available under CC BY-SA 4.0; this entry is adapted from it.
- Wikipedia: Custom-made medical device (CC BY-SA 4.0).
- Word definitions: the Codexery glossary, each quoted from its Wikipedia article.
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