Siemens Healthineers is strongly committed to a high-quality equipment and assay portfolio that enables healthcare providers to offer good patient care, medical diagnosis, and treatment monitoring.
Therefore, the new European regulations for medical devices (EU MDR) and In-vitro Diagnostic Devices (EU IVDR), which will replace the current In-vitro Diagnostic Directive (IVDD) in May 2022, are not only a challenge, but a great opportunity to support our customers.
Siemens Healthineers has for years actively implemented EU regulations into its internal processes, and these upcoming changes will be no exception.
IVDR transition phase
We have been planning the transition to IVDR for our IVDD- and CE-marked products since 2017 and have dedicated significant resources and investment in preparing for these new regulations. We intend that our products will be fully compliant and IVDR-certified in time.
Our priorities are to satisfy both the regulatory requirements and our customers’ needs to ensure availability and continued supply of our products to healthcare professionals and patients.
We are pleased to confirm that our Notified Body for in-vitro medical Devices (IVDs) has been successfully designated under EU IVDR. This paves the way for us to obtain IVDR certification.
The IVDR will be effective May 2022, with a transition period until May 2025 (and beyond for certain products, depending on the product and/or its shelf life).
In-vitro Diagnostics Regulation (IVDR) transition plan to ensure continuous availability of products
As a result, products certified under the previous directive and products certified under IVDR will coexist on the market during the transition period. Healthcare providers will benefit from the transitional provisions granted by EU legislators, which will help ensure continued availability of proven medical devices.
No action on your part is required. Local Siemens Healthineers representatives will continue to share detailed information regarding systems, assays, and consumables to keep you informed, every step of the way. Important information will also be shared on this IVDR webpage as soon as it becomes relevant and available.