EU MDR Article 18 for Implantable Medical Devices

The new medical device regulations by the name of EU MDR will be implemented in Europe by 26 May 2021. Article 18 of EU MDR requires manufacturers of implantable devices to send an implant card and relevant information to the patients who use implantable medical devices.

Demystifying Elements of Implant Medical Device Compliance

What is the Purpose of Implant Card?

Implant card gives patients a rapid access to the information which they may need regarding the implantable device. It is responsibility of the concerned member state to determine the language(s) in which the information will be presented on the implant card.

Provision of Information of Implantable Device to Patient/User

The manufacturer of implantable medical device is liable to provide the implant card in following manner:

  • The implant card should be presented in hard copy/physical copy;
  • The information presented should be comprehensible for a lay person and
  • The manufacturer should update the information where required.

What Information should be presented in the Implant Card?

Information to be provided on the Implant Card by Manufacturer (Clause-1)

(a) The manufacturer of implantable medical device shall provide the following information regarding the following in implant card:
  • Identification of Device;
  • Device Name;
  • Serial Number;
  • Lot Number;
  • UDI;
  • Device Model and
  • Name, address, and website of the manufacturer.
(b) The implant card shall contain information regarding precautionary measures. These will include:
  • Any warnings, precautions, and measures which the patient or a healthcare professional has to take regarding reciprocal interference.

The precautionary information present on the implant card shall also take either of the following into consideration:

  • Reasonably foreseeable external influences;
  • Medical Examinations or
  • Medical Conditions.
(c) The implant card shall contain information regarding expected life-time of the device and any necessary follow-up.
(d) Information to Ensure Safe Use of Device by the Patient (Annex I, Section 23.4)

Point (u) of Section 23.4 of Annex I requires manufacturers to provide information in the Implant Card that ensures safe use of the device by patient. The Implant Card should also contain details of quality and quantity of materials and substances used in implants and to which patients can get exposed.

Role of Health Institutions (Clause 2)

It is the responsibility of EU member states to direct their respective health institutions to make the information present in Clause 1 available to the patients who are using implantable devices. These health institutions shall also ensure the availability of implant card bearing the identity of the medical device.

Implantable Medical Devices Exempted from EU MDR’s Article 18 (Clause-3)

Following implantable medical devices are exempted from the requirements of Article 18 of EU MDR:

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

Provision of Updates Regarding Implants

The implant card shall contain the website through which any updates made in the implantable medical device shall be provided to the patient.

TS Q & E can help Managing Article 18

With our experts at TS Q & E, TS Q & E is in a position to offer help to companies and organizations in order to manage Article 18 of the EU MDR. Since our consultants have multiple decades experience in helping companies for regulatory compliance in medical devices, so we know what it takes for compliance for medical device implants. Our experts are also well versed in EU MDR, and so with the Article 18 of the EU MDR. Therefore companies’ professionals can contact us through our Inquiry/Contact Us page.

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.