EU Commission Publishes New IVDR Transition Extension Q&A and Updates to MDR Transition Q&A
15 July 2024
Newly Available: Notified Body IVDR Transition Extension Letter Template
26 July 2024Background
Regulation 2024/1860 has extended the IVDR, Article 110 transition period. The new deadlines allow IVDD legacy devices more time to CE Mark under the IVDR.
Various parties (e.g., customs) may ask you to provide documentation confirming that you are complying with the extension conditions. For example, the requirement for all IVDD legacy device manufacturers to implement an IVDR compliant Quality Management System by 26 May 2025.
The list new compliance dates is available here.
Need Help with the IVDR?
Whether you need a quote or just want to discuss the best options for your business, we will help guide you.
Manufacturer’s Declaration Template
MedTech Europe published a template declaration for IVD manufacturers to use. The Word document has been made freely available on their website. It can be downloaded here.
The statement is similar to the MDR declaration template, which is available on their website here.
The template is in two parts:
- Customizable section which can be edited to remove any requirements that are/are not applicable for your device(s).
- An appendix detailing the eligible device(s).
