Implant Card

Regulatory Requirements for an Implant Card

In accordance with Article 18 of the EU MDR, manufacturers of applicable implantable medical devices must provide the following information:

• Device Identification Information

The implant card must include

• Device name
• Serial number, where applicable
• Lot or batch number, where applicable
• Unique Device Identification (UDI)
• Device model
• Manufacturer's name
• Manufacturer's address
• Manufacturer's website
• Expected Lifetime and Follow-up: The manufacturer must provide information concerning the expected lifetime of the device and any necessary follow-up measures to support appropriate patient management throughout the device's intended period of use.
• Information for Safe Use: The manufacturer must provide any additional information necessary to ensure the safe use of the device by the patient, including information specified in Section 23.4(u) of Annex I to the EU MDR.

Patient Access to Implant Information

Article 18 requires the information intended for the patient to be made available through means that allow rapid access. The information must be provided in the language or languages determined by the relevant Member State, written in terms readily understood by a layperson, and updated where appropriate.

Manufacturers must make updated information available to patients through the website identified in the device identification information. The manufacturer must also supply the device identification information on an implant card delivered with the device. Healthcare institutions are responsible for making the required information available to implanted patients, together with the implant card bearing the patient's identity.

Which Implants Are Exempt from Implant Card Requirements?

Article 18(3) of the EU MDR exempts the following implants from the obligations established under Article 18:

• Sutures
• Staples
• Dental fillings
• Dental braces
• Tooth crowns
• Screws
• Wedges
• Plates
• Wires
• Pins
• Clips
• Connectors

The exemption applies to the implant card and patient information obligations under Article 18. However, the manufacturer must still comply with other applicable requirements of the EU MDR, including relevant identification, labelling, and information-supplied-by-the-manufacturer requirements.

MEDREG support medical device manufacturers in developing and implementing EU MDR-compliant Implant Cards in accordance with Article 18 and applicable Annex I requirements. Our services include implant card applicability assessment, device identification and UDI verification, preparation of patient-specific implant card templates, incorporation of manufacturer details and follow-up information. We also assist with patient-friendly language.