EU: Team-NB publishes a position paper on dental implants

The Team-NB association of notified bodies has published a position paper on dental implants. The paper interprets dental implants and abutments as part of those implants ("sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors") that are excepted from any expanded requirements in Regulation (EU) 2017/745 MDR.

This means that these products are not subject to the requirements of Article 18 (implant card and additional information), Article 52(4) (testing of each individual product file) and Article 61(4) (mandatory performance of some clinical investigations).

The requirements for retention periods (Article 10(8)), the creation of a brief report on safety and clinical performance (Article 23(1)) and the examination of the periodic safety update report (PSUR) by the notified body (Article 86(2)) remain applicable.

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