Manufacturers of implantable medical devices: new MDCG guidance on implant card! · MDlaw – Information platform on European medical device regulations

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:

(a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;

(b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;

(c) any information about the expected lifetime of the device and any necessary follow-up;

(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.

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.

Source: MDCG

Currently, the Guidance includes 88 ”device types”, subject to further updates. Below, an extract of the first 10 entries.


Source: MDCG

This new MDCG Guidance as well 2019-8 V2 Guidance are available in our Library of documents –in MDCG category.

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