IVDR. The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on …
IV diagnostic medical devices - Internal Market, Industry ...
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331 of 7 December 1998 Applicable until 25 May 2022 See …
The demarcation between the IVDR and Regulation (EU) 2017/745 on medical devices (MDR) is of particular importance because the MDR lays down in its article 1 that it shall not apply to in vitro …
At the latest from 26 September 2025, the IVDR notified body, to which the application for conformity assessment under the IVDR has been lodged, should become responsible for change notifications …
Medical Devices - In Vitro Diagnostics - Public Health
Nov 10, 2025 · Medical Devices - In Vitro DiagnosticsIn vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health...
New Regulations - Public Health - European Commission
Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro …
Update - MDCG 2020-16 rev.4 - Guidance on ... - Public Health
Mar 18, 2025 · Update - MDCG 2020-16 rev.4 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)
SANTE - Definitive adoption of new amendment to the Medical Device ...
Oct 18, 2024 · As proposed by the European Commission in January 2024, on 13 June 2024 the European Parliament and the Council adopted Regulation (EU) 2024/1860 amending Regulations …
MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (May 2022)
Manufacturer IVD - Public Health - European Commission
The IVDR has the same basic requirements as the previous Directive. It is generally more stringent than the Directive, especially in terms of risk classes and the oversight provided by notified bodies (NBs).