Helsinki Procedure for borderline and classification under MDR & IVDR

Name: Helsinki Procedure for borderline and classification under MDR & IVDR
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: borderline,classification,guidances,in-vitro-diagnostics-regulation,ivdr,mdr,medical-devices-regulations,procedures

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Borderline And Classification

Published

September 1, 2021

Last updated

September 1, 2021

Description

Learn about the Helsinki Procedure for borderline and classification under MDR & IVDR.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

Helsinki Procedure

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/2e667094-2eaf-4370-9861-d1a283210da7_en?filename=md_border-class_helsinki-proc-mdr-ivdr_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c2f9875c-f43f-4e07-bae6-dbd558cb97b2
MIME Type: application/pdf

Created on: September 6, 2023
Modified on: September 6, 2023