EU IVD Regulation 2017/746 consolidated version has been updated with the latest transition timelines and amendments. You can access the legislation here.
Ben KempAugust 14, 2024
Regulation (EU) 2024/1849 of the European Parliament and of the Council of 13 June 2024 amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions Text with EEA relevance. You can find the legislation here.
Ben KempJuly 17, 2024
The EU have published their ‘right to repair’ directive. This is regarding consumer devices (listed in Annex II), with MDs and IVDs being out of scope. However we could see the scope widen in the future. Article 1 Subject matter, purpose and scope This Directive lays down common rules strengthening the provisions related to the repair of goods,…
Ben KempJuly 17, 2024
On 08 July, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Rev. 3 guidance on "the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746". This document provides updates from the previous revision released in February 2023. These include: Addition of ‘kit’ definition Revision of examples for Rule 3(a) and Rule 6 Revision of Rule…
adminJuly 10, 2024
On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by: Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31…
adminJuly 10, 2024
Public consultation: conflict-of-interest rules under the EU Health Technology Assessment Regulation
The European Commission have launched an online public consultation on the draft implementing act on the management of conflicts of interest in Health Technology Assessments. The draft implementing act provides rules for managing conflicts of interest of actors such as the representatives in the Member State Coordination Group and its subgroups, assessors, patients, and clinical and other experts who participate…
adminJune 4, 2024
The REACH Restriction of D4/5/6 was published in the EU Official Journal on 17 May 2024. It will enter into force 20 days from the date of publication. This marks the end of the legislative process for the regulation of this substance under the Restriction route. The following derogations requested by MedTech Europe have been granted: The new transitional period…
adminMay 22, 2024