MDCG Guidance documents summary series:
Introduction
Under MDD and AIMDD already it was required to provide patients with an Implant Card, or Implant Pass, for implantable Medical Devices, but this was not a harmonized process, and the national requirements differed between the EU Member States.
With the MDR 2017/745 Art. 18, “Implant card and information to be supplied to the patient with an implanted device”, this process will be more streamlined, and transparent within the EU.
The MDCG supports Member States, Manufacturers, and other Stakeholders with Guidance MDCG 2019-8 v2 describing the layout, intent and content of the Implant Card, including who, and how to complete it prior to handing it to the patient.
To avoid duplication and confusion on “Device Model”, which is not defined by the MDR, but already part of the UDI-DI related information, the MDCG clarifies this issue and suggests the term “Device Type” instead.
The MDCG 2019-8 v2 says to include a “Device Type” as identifier of a device, but no definition of device type was provided.
Additional guidance within MDCG 2021-11 provides a list of usable “device types” for implantable devices, which might be updated at a later stage.
MDR 2017/745 Art. 18:
Paragraph 1 lists the information a manufacturer shall provide to the patient, to allow the implanted patient, and health institutions, rapid access to the information, in a language understandable by lay persons, and languages as required by the relevant Member states.
The information mentioned in lit. (a), allowing the identification of the device, are to be provided on an implant card delivered with the device. These are:
- the device name,
- serial number,
- lot number,
- the UDI,
- the device model, the name, as well as address and the website of the manufacturer.
Additional information required for patient information are listed in Paragraph 1 lit. (b) “any warnings, precautions or measures to be taken by the patient or a healthcare professional”, lit. (c) “any information about the expected lifetime of the device and any necessary follow-up”, and lit. (d) “any other information to ensure safe use of the device by the patient”.
Paragraph 2 delegates to the Member States the responsibility to “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.”
Paragraph 3 lists the exempted implants, for which an Implant Card is not required: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
MDCG 2019-8 v2 Content:
The MDCG refers to Art. 18 of MDR 2017/745, highlighting the three purposes of the Implant Card:
- Enable the patient to identify the implanted devices and to get access to other information related to the implanted device (e.g. via EUDAMED, and other websites).
- Enable patients to identify themselves as persons requiring special care in relevant situations e.g. security checks.
- Enabling e.g. emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations
In this guidance, the MDCG provides an illustrative blueprint of an Implant Card (IC), for an implantable medical device, and several examples for front and back view of the IC, or for a foldable system IC (for implantable systems), as well as instruction leaflet, with or without stickers.
Language and Symbols:
It is recommended manufacturers use symbols on the IC for:
- patient ID,
- name and address of the implanting healthcare institution/provider,
- date of implantation,
- name and address of the manufacturer,
- serial number,
- lot number/batch code,
- device name,
- patient information website
- UDI
This means the ICs do not need to be translated into each national language, only the information on “Device Type” will then require translation.
The explanation of the symbols then can be provided on an accompanying leaflet with required translations, but note that this shall be a single document and not be included in the information to the patient under Art. 18 papa 1 lit b, c and d.
The symbols listed here to indicate the following terms: ‘Device Name’, ‘Patient Name or Patient ID’, ‘Date of Implantation’, ‘Name and address of the implanting healthcare institution/provider’ on the implant card, are already published in existing ISO Standards, although used in the ISO context to indicate ‘Medical Device’, ‘Patient Identification’, ‘Date’, ‘Health Care Center or Doctor’.
Also, in the ISO context, “the ‘MD’ symbol is used to identify that the product in question is a medical device. On the implant card”, but in the IC this symbol is used to indicate the device name.
“The symbols for device name, patient information website and UDI have been validated by users according to the ISO 15223-2 process.”
Size:
The size of the IC should be that of a credit card, or ID card, conform to standard ISO/IEC 7810 ID-1 (85.60 mm × 53.98 mm / 3 3⁄8 × 2 1⁄8 inches, and with a radius of 2.88–3.48 mm3)
Handwritten information: Enough space should be on the IC to allow health institutions to add the patient name or patient ID, the date of implant, the name and address of the implanting healthcare institution and provider.
Risk Management:
“As part of the risk management, the manufacturer has to investigate, by means of an ergonomic analysis or ergonomic usability test procedure, if the provided instructions are sufficient to enable the health professional to complete the IC correctly. The instructions must reflect the solution chosen by the manufacturer (e.g. pre-printed IC, blank IC with sticker(s) to be added, mixture of both). Special considerations might be needed when providing a system IC or an IC for a separate implantable component, when there is not yet a common practice (standard) established.“
MDCG 2021-11 Content:
Since the MDCG 2019-8 v2 instructs to include a “Device Type” instead of “Device Model” as identifier of a device on the Implant Card, without providing a definition of it, the guidance MDCG 2021-11 provides a list of usable “device type” terms, and pictures an example of languages and the location on the Implant Card.
The MDCG considered the understandable language for the lay person and the terminology for healthcare professionals by creating the list of suggested terms.
The non-exhaustive list, which might be updated at a later stage, currently includes terms of the “Device Type” for 88 implantable medical devices.
Other helpful MDCG Guidance
· MDCG 2021-08 Clinical investigation application/notification documents, see also our blog: Summary of the MDCG Guidance Document MDCG 2021-8.
· MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation, see also our blog: Summary of the MDCG Guidance Document MDCG 2021-28.
· MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations, see also our blog: Summary of the MDCG Guidance Document MDCG 2021-20.
· The MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (respectively referrals to: Art. 70, Art. 73, Art. 74, Art. 75, Art. 76, Art. 77, Art. 78, Art. 80), see also our blog: Summary of the MDCG Guidance Document MDCG 2021-20.
· MDCG 2019-9 Rev.1 Summary of safety and clinical performance A guide for manufacturers and notified bodies, see also our blog: Summary of the MDCG Guidance Document MDCG 2019-9 Rev.1.
In addition, helpful guidance is provided for “actors” registration under MDR:
· MDCG 2020-15: MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
· MDCG 2021-13 rev.1: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives, and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.
Thank you for your time. If you found this interesting, please check-out for our next blog on the MDCG Document summaries.
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