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

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website