MDCG 2020-16 Rev.3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024
Year: 2024
Type: other
Abstract: The guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices addresses the classification of in vitro diagnostic medical devices and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales. Read the news announcement published by EC Directorate-General for H...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/125v6
Author: Lsgilbert
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6974410209
Cites:
Cited by:
Related to: