The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and distributors of in vitro diagnostics medical devices in the EU must comply with the new Regulation, except for certain medical devices that have been granted longer transition periods (for more information refer to our blog, EU In Vitro Diagnostic Medical Device Regulation). This Regulation applies to all in vitro diagnostic medical devices for human use and accessories for such devices and performance studies related to in vitro diagnostic medical devices and accessories conducted in the EU. 

This Regulation does not apply to:

1. Products for general laboratory use or research-use only products, unless such products, given their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
2. Invasive sampling products or products that are directly applied to the human body to obtain a specimen;
3. Internationally certified reference materials;
4. Materials used for external quality assessment schemes.

This Regulation does not affect:

• The applicable Directive 2013/59/Euratom.
• The right of a Member State to restrict the use of any medical devices that are NOT covered by this Regulation.
• National law in relation to the organization, delivery, or financing of health services and medical care.

What has Changed?

The new EU IVDR captures all the requirements as the previous Directive 98/79/EC and includes additional new requirements to emphasize a life-cycle approach to safety. The new Regulation outlines more stringent rules for the designation of Notified Bodies, adds more control and monitoring requirements for national competent authorities and the Commission and clarifies the obligations of manufacturers, authorized representatives, importers, and distributors.

An additional pre-market consultation procedure is introduced for certain high-risk medical devices. As for IVD, approximately 85% of the IVDs would need oversight from Notified Bodies as opposed to 20% under the old Directive. This Regulation increases transparency and mandates the publication of information related to medical devices and clinical and performance studies to ensure conformity (through the medical device database, EUDAMED).

Other changes such as increased traceability, strengthening requirements on clinical evidence and performance evaluation, adopting a new regime for in-hour devices, fortifying requirements for post-market surveillance, improving coordination between EU countries, etc are also delineated in the new Regulation.

However, due to the abrupt outbreak of COVID-19 and to avoid disruption in the supply of medical devices, the transitional period for certain risk and type of medical devices as mentioned in Article 110 of the IVD Regulation have been extended.

To find out if your medical device is eligible for a longer transition period or to find out more about the new Regulation, please contact us today.