In vitro diagnostic medical devices
Directive 98/79/EC provides a high level of protection for the health and safety of patients, users and others and ensures the devices achieve the results for which they are intended. It sets out the essential safety, health, design and manufacturing requirements that in vitro diagnostic medical devices and their accessories must meet.
Legal act:
Regulation (EU) 2017/746 and Directive 98/79/EC until 25/05/2020 (Partial end of validity)
Parts of Directive 98/79/EC that remain active:
Regulation (EU) 2017/746, Article 112 - Repeal
Consolidated act:
05/05/2017 of Regulation (EU) 2017/746
11/01/2012 of Directive 98/79/EC
Legal acts repealed by Regulation (EU) 2017/746:
Directive 98/79/EC (Partial repeal from 26/05/2022)
Previous guidelines:
Guidelines on a Medical Devices vigilance system - January 2013
Additional Guidance Regarding the Vigilance System
Guidelines on Medical Devices - IVD Medical Device Borderline and Classification issues - A Guide for manufacturers and Notified Bodies - January 2012
Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council - OJ L 90 I of 25 March 2020
Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices - OJ C 389 of 17 November 2017
Guidance on CE marking for professionals
Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment - OJ C 8 of 11 January 2021
Update joint assessments for publication - Overview of the bodies at each stage of the process - March 2020