Implantable Medical Devices – Important Areas of EU MDR Compliance

European Union has recently imposed its new regulation regarding medical devices by the name of Regulation (EU) 2017/745. Another name for this regulation is MDR (Medical Device Regulations).

The reason for introducing this new law is to ensure transparency in the European medical device manufacturing industry. The requirements of this new regulation apply to all kinds of medical device manufacturers, including those who manufacture Implantable Medical Devices.

With the imposition of this new regulation, these implantable medical device manufacturers are now required to provide Implant Card (IC) with their Implantable Medical Devices.

What to Expect from Implant Cards?

With the arrival of Implant Cards, all the relevant information regarding the implanted device will be accessible to the patient.

What Purposes do Implant Cards Serve?

Implant Cards have various important purposes such as:

Assisting in Identification of the Implantable Device

With Implant Card, the patient will be able to

  • Identify the implantable device
  • Access safety-related information of the device via the EUDAMED database website.

Helping the Patients in Special Situations

Implant cards can help patients in certain special situations, such as

  • Passing through security checks
  • Informing emergency clinical staff and first responders about their special needs.

Which Medical Devices Require the Implant Card?

All implantable medical devices require the Implant Card except the following devices:

  • Sutures
  • Staples
  • Dental Fillings
  • Dental Braces
  • Tooth Crowns
  • Screws
  • Wedges
  • Plates
  • Wires
  • Pins
  • Clips
  • Connectors.

Information to be Provided by Manufacturers on Implant Cards

Article 18 of paragraph 1a of the MDR requires implantable device manufacturers to provide the following information on the Implant Card. This information can be provided either on the Implantable Card itself or through a sticker placed by the clinician.

Required Information

The implantable device manufacturer shall provide the following information:

  • Device Name
  • Device Type
  • UDI (Unique Device Identification). This UDI will be in Automatic Identification and Data Capture (AIDC) format (e.g., linear or 2D-barcodes). As for the UDI Device Identifier (UDI-DI), it should be in human-readable form
  • Serial Number
  • Lot or Batch Number (where applicable)
  • Name and Address of the Medical Device Manufacturer
  • Website of the Medical Device Manufacturer.

Blank Fields in the Implant Card

The manufacturer should include some blank fields in the Implant Card to be filled by the implanting healthcare institution or healthcare provider. These fields include:

  • Patient’s Name or Patient’s ID
  • Implantation Date
  • Name and Address of the Institution where Implantation was Performed.

Size Requirements of the Implant Card

For Outer Dimensions of the Implant Card

85.6mm x 53.98mm.

For Radius of the Implant Card

The radius of the card should range from 2.88 to 3.48 mm.

Text Present on Implant Card

Text on the Implant Card is made up of the following:

  • Any number
  • Any letter
  • Any symbol
  • Any letters and numbers included in a symbol.

Readability Requirements of the Text Present on Implant Card

  • The text provided on the IC must be at least 2 millimeters high
  • Information shall be readily understandable by a layperson
  • The information shall be provided by means that make the information readily accessible
  • The information should be provided in the language provided by the relevant Member State.

Use of Symbols on the Implant Card

Using symbols in Implant Card is advisable. Regarding these symbols, an explanation regarding these ICs should be provided either

  • In a leaflet
  • On the back of the IC (is there is space).

The list of recommended symbols can be seen in MDCG 2019-8 V2.

Language Use on Implant Card in a Member State

  • Language required by the relevant Member State should be used to provide the relevant information on the Implant Card
  • On the Implant Card, there isn’t any symbol for the field “Device Type.” Therefore, the information regarding the Device Type should be in the language accepted/required by the Member State
  • To provide the information regarding Device Type on Implantable Cards, different measures can be taken, such as:
    • The information can be printed on the IC in different languages, or
    • Stickers are provided with the IC from which the healthcare professional will select the correct one.

What are the Uses of Implant Card Leaflet?

The manufacturers are required to provide the healthcare professional a leaflet along with the Implant Card. This leaflet will contain the necessary instructions for completing the IC and an explanation of the symbols used.

Note: The instructions provided in the leaflet should be in the language(s) required by the relevant Member State.

In addition to the instructions on IC, MDR’s Article 18 (paragraph 1 clauses b-d) requires manufacturers to provide the following information in the IC leaflet:

Warnings and Precautions

Any warnings and/or preventive measures the doctor or patient should take with regards to reciprocal interference with reasonably foreseeable

  • External influences
  • Medical examinations
  • Environmental conditions.

Information Regarding Device’s Expected Lifetime

The leaflet should contain information about the device’s expected lifetime and any necessary follow-up.

Information Ensuring Safe Use of the Device

Any information ensuring safe use of the device by the patient. This also includes qualitative and quantitative information on materials and substances to which the patients can get exposure.

Updating the IC Information

When and wherever update, IC information should be updated. These updates should be made available to the patients via the website indicated on the Implant Card.

Implantable Components in Implantable Devices

For an implantable device that contains the implantable components to be replaced either by the same or different components, the manufacturers sHould consider using System IC. An example of this can be seen in MDCG 2019-8 V2, Annex I.

Need MDR Compliance for Implantable Medical Devices?

TS Q and E are providing implantable medical device companies with comprehensive solutions to implantable medical device manufacturers. Our consultation helps implantable medical device manufacturers in providing EU MDR-compliant Implantable Cards. Contact us today by visiting our website, and benefit your company with our IC solution.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.