The MDCG has released a very important guidance on the ”device type” to be shown on the implant card of an implantable medical device as per the MDCG Guidance 2019-8 issued under Article 18 of the MDR that obliges:
1. The manufacturer of an implantable device shall provide together with the device the following:
The MDCG 2019-8 requires from a manufacturer of an implantable medical device to include a ”device type” also as information allowing the identification of a particular device (see below highlighted in red). The new Guidance presents a non-exhaustive list of implantable medical ‘device types’ to assist manufacturers in generating the implant card of their devices.
Currently, the Guidance includes 88 ”device types”, subject to further updates. Below, an extract of the first 10 entries.
This new MDCG Guidance as well 2019-8 V2 Guidance are available in our Library of documents –in MDCG category.
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