European Parliament voted to extend MDR amend and IVDR adopted
ISS AG, Integrated Scientific Services
Professional support for MedTech companies: Medical Devices & IVD Regulatory Compliance
Yesterday, the European Parliament voted to adopt the MDR and IVDR implementation amendment without any changes to the version published in January. It will take several days until the proposal will be published in the Official Journal. However, once published, the proposal will come into force immediately as a matter of urgency.
The changes to MDR’s Article 120, will introduce extended transition periods for legacy devices, includes an amendment explicitly for class III custom-made implantable devices and removes the under MDR and IVDR established sell-off date of 26 May 2025.
The extension is subject to conditions ensuring that only safe devices benefit from the additional time. Moreover, the manufacturers need to have taken certain steps to transition towards compliance with the MDR.?
Find the amending Regulation (in all official EU languages) here:?Transitional provisions for certain medical devices and in vitro diagnostic medical devices