IDS has successfully achieved the first important goal in the transition to the new IVDR. On the 26 May 2022 IDS released CE marked IVDR Class A instruments and reagents in compliance with the new EU IVDR regulation. The launch of IVDR compliant class A products is an important milestone which ensures that the laboratories that use IDS products will continue to be able to use these products without disruption.
Immunodiagnostic Systems (IDS) is committed to managing the important transition from the EU In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR) to ensure our vital products will be always available to healthcare professionals whilst ensuring a high level of quality, and safety for patients and users.
IDS continues to work intensively on a transition plan which will ensure the remaining IDS IVD medical devices are IVDR compliant before the revised transition dates, and all new or revised devices are IVDR compliant before being placed on the market.
- IDS has engaged TÜV Rheinland as Notified Body to perform the conformity assessment of our devices to the IVDR.
- A cross-functional team at IDS is working on the implementation of the IVDR requirements across the company; this includes a close review of our product portfolio and processes.
- Our QMS audits by TÜV Rheinland were passed in November 2021 without any non-conformities for our Automated and ELISA/RIA products.
- Our first technical document reviews by TÜV Rheinland are close to completion
Immunodiagnostic Systems strives to provide products of the highest quality. We value your business and thank you for your continued support. Please contact your local IDS representative if you have any questions regarding this information.