European Regulations DOUE Importance: 5/10

EU updates list of class IIb medical implants not requiring mandatory individual technical review

29 Jun 2026 24 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 …

PRO exclusive content

Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.

Crear cuenta gratis Ver planes PRO

Full official title

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

View original source (DOUE)

Affected sectors

SMEs Technology Healthcare

Categories

Tax & Revenue Labour & Employment Corporate & Business Data Protection Social Security European Regulations Grants & Subsidies Other Regulations Public Sector Education Energy Agriculture & Fisheries Real Estate

PRO Plan

Alerts, detailed analysis and private Telegram channel.

From 9.99 EUR/month
Sponsored space
Sponsor the European Regulations category

Your brand in front of thousands of businesses and freelancers tracking the legal changes in your sector.

I want to sponsor it

Related regulations