EU updates list of medical implants and high-risk devices exempt from prior clinical trials
29 Jun 202683 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
PRO
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…
PRO exclusive content
Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.
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
The European Commission modifies for the 362nd time the list of persons and entities sanctioned for their links to Daesh and Al-Qaeda. These sanctions involve a...
Financial entities, companies with international activity and any person operating with sanctioned listed persons
The European Commission requires registration of polyvinyl alcohol imports from China to be able to charge retroactive tariffs if dumping is confirmed.
European importers of Chinese polyvinyl alcohol and companies that use it as raw material
A new regulation has been published in the Official Journal of the European Union. The specific content requires direct consultation of the official text.
To be determined according to the content of the official text
The EU applies temporary measures to facilitate the import of Armenian products without tariffs. It seeks to provide economic support to the country in a comple...
European and Spanish importers of Armenian products, manufacturing and agri-food sectors
