EU updates list of class IIb medical implants not requiring mandatory individual technical review
29 Jun 202654 views
Who is affected:
Class IIb medical implant manufacturers, notified bodies and healthcare distributors in the EU
Summary
The EU modifies which medium-high risk medical implants are exempt from case-by-case documentary review. Affects manufacturers and notified bodies in the healthcare sector.
Detailed analysis
PRO
This Delegated Regulation amends Regulation (EU) 2017/745 on medical devices, updating the list of class IIb implantable products exempted from the obligation for a notified body to evaluate the technical documentation of each product individually. Class IIb groups medium-high risk implants such as joint prostheses or …
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Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.
CELEX:32026R1359: Reglamento Delegado (UE) 2026/1359 de la Comisión, de 20 de marzo de 2026, por el que se modifica el Reglamento (UE) 2017/745 del Parlamento Europeo y del Consejo en lo que respecta a la lista de productos implantables de la clase IIb exentos de la obligación de evaluar la documentación técnica de cada producto
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