Implantable medical device

In ISO 13485 the term triggers extra requirements, such as traceability records of the components and materials used, the identity of the people who inspected and tested the device, and the name and address of the consignee for each shipment. The EU MDR defines the related term implantable device in Article 2(5), so check which definition applies to your market.

medical device which can only be removed by medical or surgical intervention and which is intended to: — be totally or partially introduced into the human body or a natural orifice, or — replace an epithelial surface or the surface of the eye, and — remain after the procedure for at least 30 days Note 1 to entry: This definition of implantable medical device includes active implantable medical device.

ISO 13485:2016, clause 3.6