EU updates list of medical implants and high-risk devices exempt from prior clinical trials
29 Jun 202654 views
Who is affected:
Manufacturers of implantable and class III medical devices, notified bodies
Summary
The EU modifies which implantable medical products and class III devices are exempt from mandatory clinical research requirements. Affects manufacturers of high-risk medical devices.
Detailed analysis
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This Delegated Regulation amends Regulation (EU) 2017/745 on medical devices, updating the annex of implantable products and class III devices that are exempt from the obligation to conduct prior clinical investigations before placing them on the market. The exemption applies when sufficient clinical data exists from e…
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CELEX:32026R1451: Reglamento Delegado (UE) 2026/1451 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 y productos de la clase III exentos de la obligación de llevar a cabo investigaciones clínicas
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