In Vitro Diagnostic Regulation – Clarity and Confidence
EU Regulation of Medical Devices and Lab-Developed Tests
Overcome the complexities of your In Vitro Diagnostic Regulation (IVDR) transition. We’re with you through the rough terrain.
The IVDR transition will bring positive changes to EU regulation of medical devices and lab-developed tests. It also presents potential obstacles – which we can help you conquer quickly. With our ability to help ensure your compliance, supply consistency, validation, and scalability, we offer clarity and confidence for your IVDR transition.
What is the IVDR?
The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new Regulation which will create a robust, transparent, and sustainable regulatory framework that “improves clinical safety and creates fair market access for manufacturers and healthcare professionals”.1
The IVDR “brings EU legislation into line with technical advances, changes in medical science and progress in law-making.”1 IVDR has binding legal enforcement throughout all EU member states and it sets higher standards for quality and safety of IVD devices.
What is the timing?
In 2022, the EU will begin to enforce the transition from the current In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) for clinical diagnostic applications.
On May 26th, 2022 the IVDR, becomes effective meaning after that date, any new IVD devices placed on the market must be CE marked according to IVDR.
A recent amendment by the commission to the implementation of the IVDR allows some existing products (excluding class A non-sterile devices) to continue to be placed on the market in compliance with the IVDD. The length of the extension is dependent on risk class.
Any class A non-sterile products including instruments distributed before May 26th, 2022, may be used until end-of-life.
Which products are affected?
All IVDs manufactured with a CE mark will be affected by the IVDR.
Product Support and Development
As the world leader in serving science, we are fully committed to developing and marketing IVD devices for molecular diagnostics. To this end we are running a cross-functional, global program with the objective to ensure future IVD devices that are CE marked according to IVDR.
For more information about the transition or products under development, please contact the Thermo Fisher Scientific transition team (please specify in the subject line, the specific nature of your inquiry) or technical support.
Transition Assistance and Personalized Plans
Thermo Fisher Scientific has IVD transition assistance and promotions that you may qualify for.
Please contact the Thermo Fisher Scientific transition team (please specify in the subject line, the specific nature of your inquiry) for more information and a personalized IVD transition plan.
Our Commitment to You
Thermo Fisher Scientific is committed to supporting all our customers during this transition phase. If you have any questions, please contact the Thermo Fisher Scientific transition team (please specify in the subject line, the specific nature of your inquiry).
We thank you for your continued support of Thermo Fisher Scientific products.