MDR Article 18

Article 18 

Implant card and information to be supplied to the patient with an implanted device

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 information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.

In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.

2. Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.

3. The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.

Explanation

For manufacturers of implants, for example, a knee joint or pacemaker, there are some special requirements related to labelling. The implant manufacturer has to provide, with the device, information that makes it possible to properly identify the actual implanted device by providing this information on a label. And that label is what is generally referred to as the implant card. Please note that some “simple” and widely used implants are excluded from this requirement, for example, sutures, staples, or dental fillings. So don’t expect an implant card if you have had a birthmark removed and have received a few stitches. The implant card and the information on it must be given to the PATIENT that receives the implant. Therefore it shall be presented in such a way that a layperson understands the information and is able to locate additional information on the web.

What information should be on a medical device implant card?
The following information shall be on all implant cards:

  • Device name
  • Serial number/ LOT
  • UDI-DI
  • Device type
  • Device model = Device type (acc to MDCG 2019-8)
  • Manufacturer (and address)
  • Website (for additional information from the manufacturer)

Furthermore, if applicable, the information below shall also be given to the patient that receives the implant. Warnings:

  • Precautions to reciprocal interface with external influences or environmental conditions
  • Expected lifetime
  • Information for safe use incl. materials and substances (identifying the overall qualitative and quantitative information on the materials and substances to which patients can be exposed)
 
The information above does not have to be on the actual label, thus it is likely to be given to the patient in a supplemental leaflet. But there is sufficient space on the label, it may be found there too.

Relevant courses

Find out more about the requirements by registering for the MDR course below:

Relevant templates

N/A

Applicable MDCG guidance documents

Relevant blog posts

YouTube videos

About the author

Pontus Gedda - Medical Device HQ instructor

Pontus Gedda

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.

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