The IVDR (In-vitro Diagnostic Medical Device Regulation)
The new IVDR (In-vitro Diagnostic Medical Device Regulation) has been in force since 26 May. As a result, numerous companies have had to adapt their approval processes and internal procedures. The new regulations also present oncgnostics with new challenges. For example, the molecular biological cancer tests now fall into the second highest risk level. This means that significantly more requirements have to be met.
What is the IVDR?
The In Vitro Diagnostic Medical Device Regulation, IVDR for short, is an EU regulation that replaces the previous directive, the In Vitro Diagnostic Medical Device Directive (IVDD). Thus, the IVDR regulates the general safety and performance requirements of in vitro medical diagnostics devices within the European Union. Although the new regulation has already existed since 25 May 2017, it is now mandatory after a five-year transition period. For many companies, the new requirements mean major changes.
The most important changes (selection)
The introduction of the new IVDR is accompanied by several changes. The aim of the new regulation is to improve patient safety.
- New classification of products into four classes: There are risk classes, ascending from A to D.
- Common specifications: The EU Commission defines common specifications.
- UDI system: With the help of the Unique Device Identification, UDI for short, the traceability of each product from the patient via the doctor back to the laboratory is to be guaranteed.
- Every manufacturer of an in-vitro diagnostic product must install a QM system.
- Technical documentation: especially the requirements for technical, analytical and clinical performance data have increased in scope.
- Software: The IVDR now formulates specific requirements for products that contain software.
What the new IVDR means for oncgnostics GmbH
oncgnostics launched GynTect, the screening test for cervical cancer, back in 2015. At the time, this was possible with a CE IVD approval through a self-declaration of compliance. In addition, GynTect fell into the “other” category under the previously valid directive. In the new IVDR classification system, GynTect now falls into the second highest risk level “C”. As a result, the conformity assessment procedure has to be carried out with the involvement of a Notified Body. For products that have already been approved, this means that this must take place in four years at the latest. The same applies to the ScreenYu Gyn test, which was approved only recently, in May 2022.