Team-NB, the European Medical Devices Notified Body Association, published a position paper on the applicability of implant cards as required under Regulation (EU) 2017/745 on medical devices (MDR). Readers should be aware that the position paper is neither a legislative document nor an official European Commission guidance document. Rather, it reflects the position of notified bodies on certain topics.
Article 18 of the MDR specifies requirements for an implant card for implantable medical devices. As per article 18(3), certain devices, e.g. sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, have been exempted from this requirement.
The position paper suggests a risk-based approach to estimate in how far the implant card requirements apply – also for exempted products. This is due to the fact that the MDR wording in article 18 leaves room for interpretation:
“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 result of the conducted risk management by the manufacturer and may result in the decision to issue implant card also for devices within the list of exempted device types in Article 18.3.”
The position paper also includes a useful flowchart to reach an informed decision.
Should you wish us to provide the paper, please don’t hesitate to get in touch or go to our download section.
Source: Team-NB position paper