Implantable device

Implantable devices face stricter EU requirements, such as implant cards and, for many, class III status. The EU and US definitions do not match, so the classification rationale should be checked for each market.

‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;

EU MDR, Article 2(5)

Implantable device means a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner of Food and Drugs determines otherwise in order to protect human health. Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.

21 CFR, 801.3

The MDR covers any device totally introduced into the body, or replacing an epithelial surface or the surface of the eye, that remains after the procedure; the 30-day minimum applies only to partially introduced devices. 21 CFR 801.3 uses a 30-day continuous implantation threshold for all devices.