Implant card: MDCG Guidance & Team-NB Position Paper
Recital 39 of MDR - Regulation (EU) 2017/745 states: ‘’Patients who are implanted with a device should be given clear and easily accessible essential information allowing the implanted device to be identified and other relevant information about the device, including any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls. ''
In March 2020, the Medical Device Coordination Group (MDCG) published a Guidance document to help manufacturers better understand the requirements related to the Implant Card set out by Article 18 of the MDR.
The Regulation also provides a list of certain implantable device types exempted from those requirements. These implants are listed in Article 18(3): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. While these devices are excluded from the statutory requirement to provide an implant card (Art. 18(1) a)) and patient information materials (Art. 18(1) b, c, d), manufacturers might still consider using a risk-based approach providing an implant card and patient information materials for these devices, as part of their overall risk management
The use of more general terms might lead to a wide interpretation in the respective fields of application. The general terminology (e.g., screws, wedges, connectors) listed in Article 18(3) allows for an interpretation and is not always clearly defined in the medical field. Especially, the term ‘wedge’ is not a defined medical device. For this reason, the European Association of Medical Device - Notified Bodies (Team-NB) Position Paper, was published on July 20, 2021, proposing to use a risk-based approach to determine which of those exempted implantable devices shall be supplied with the implant card, despite appearing among the exemptions from the requirements set out in MDR Article 18(3).
Despite both the MDCG Guidance and the Team-NB Position paper neither have specific legal implications neither can be regarded as reflecting the official position of the European Commission, the documents can help to deepen the knowledge and guide the manufacturer in complying with the related legal requirements to ensure the safety of the patients. Moreover, the MDCG Guidance could be taken into consideration by the EU Court of Justice as of the state-of-art on the interpretation of specific MDR provision; thus, we highly advise to read and follow it.
What is an implantable device?
According to MDR Art. 2(5), a device shall be deemed to be an implantable device if it respects the following conditions:
- It is completely inserted inside the human body or if it replaces an epithelial surface or the surface of the eye
- It is introduced by clinical intervention and
- It remains in place after the procedure for at least 30 days.
What is an implant card?
According to MDR Art. 18, manufacturers of implantable devices shall supply an implant card to be used by patients in case they need rapid access to important information such as:
- The identification of the device;
- Warnings, precautions, or measures to be taken by the patient or a healthcare professional
- The expected lifetime of the device and any necessary follow-up;
- Instructions for a safe use of the device by the patient.
The implant card aims to ensure that both the patient and the healthcare provider can make informed and safe decisions, especially in an emergency where timing can be crucial to safeguard the patient’s health .
Which implantable devices are excluded from the requirement related to the Implant Card and patient information?
According to MDR Art 18(3), the only implantable devices exempted from the Implant Card obligations are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Due to the general terminology, there is a multitude and heterogeneity of devices that could be considered exempted from the requirements of having an implant card and to supply relevant information to the patient.
Team-NB considers that a risk-based approach could be potentially used to determine if the device shall be provided with the Implant Card. Based on the result of the conducted risk management, Team-NB advises that the manufacturer shall issue an implant card also for the devices listed in Article 18(3). Especially, for cases where this would represent an effective measure to mitigate clinical risks as far as possible and to reduce the potential risk of harming the patient.
The exemption of device types from the requirement of Article 18 is not understood to overrule:
- The requirement to perform a risk analysis for the device in questions in conformity with Annex I, 3.; and
- To provide safety related information to the user in conformity with Annex I, 4(c).
The decision to provide an implant card should be based on the results of the conducted risk management by the manufacturer and may result in the decision to issue an implant card also for devices within the list of exempted device types in Article 18(3).
According to the risk-based approach which devices listed in MDR Art. 18(3) should or should not be supplied with the Implant Card?
Among the devices listed in Art. 18(3), the ones that are considered exempted from the Implant Card are the following:
- Devices used in short-term implantation and/or resorption for less than 30 days;
- Devices partially implanted;
- Device that can be identified without any invasive medical or surgical procedure.
For the above devices the Implant Card has no additional benefit to the patient.
On the other hand, the Implant Card can be considered as a relevant risk mitigation measure to ensure patient safety for:
- Devices with special considerations (Electromagnetic Fields, specific instruments, incorporating a medicinal substance, Allergy potential);
- Novel Devices;
- Devices bearing residual risks physicians are not aware of.
Are you aware of all obligations that a manufacturer of an implantable device shall follow? Contact us today and we will gladly guide you in your path to EU Compliance!Get in touch
Maria Giulia Sardone
Regulatory Affairs Department
· The European Association Medical Devices - Notified Bodies. (2021). Team-NB Position Paper Implant Card. Retrieved on 22/09/2021 from https://www.team-nb.org/team-nb-position-paper-on-implant-card/
· Medical Device Coordination Group .(2020). MDCG 2019-8 v2 Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Retrieved on 22/09/2021 from https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
· Official Journal of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 18/12/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745