The In Vitro Diagnostics Regulation (IVDR) has become effective on May 26, 2017.
It replaces the existing In Vitro Diagnostics Directive (IVDD). Anyone wishing to place IVDs on the market in Europe in the future will have to comply with new legal requirements.
The IVD Regulation introduces significant changes compared to the IVD Directive:
- New risk classification of in vitro diagnostic devices including IVD devices according to Annex VIII IVDR 2022/746 EU and MDCG Guidance 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_de
- Obligations of economic operators (manufacturers, authorized representatives, importers, and distributors) are specified
- Requirements for post-market surveillance and vigilance are tightened
- Unique Device Identifier (UDI) for each product
- Transparency regarding higher risk items will be improved via information in the European Database for Medical Devices (EUDAMED).
- May 26, 2022 marked the effective date of the IVDR Regulation. Those products already legitimately placed on the market under IVDD (Directive 98/79/EC) may still be made available in the market or put into service according to their IVDR risk class within a given transition period (Article 110 of the IVDR). However, provided that no significant changes are applied to the product, which affect its intended purpose.
- The IVDR Amendment Regulation in the EU Official Journal of Jan. 28, 2022, extended the transition periods. The new transition periods specify when products must be placed on the market in conformity with the IVDR as follows:
Risk class D products until 26 May 2025
Risk class C products until May 26, 2026
Risk class B products until May 26, 2027
Risk class A products sterile until May 26, 2027
- DiaSys has started implementing the new legal requirements and plans to transfer the products to be covered by the IVDR within the legal transition periods.
- The first conformity assessment procedures with the Notified Body started in October 2021.
- DiaSys will bring its products under the IVDR in several waves. The first wave includes 16 parameters including calibrators and controls.
- The new conformity assessment procedure involves a QMS audit to verify the implementation of IVDR relevant elements within the quality management system. DiaSys has already successfully passed this audit as part of the annual QMS audit by the Notified Body.
- However, the IVDR-compliant products can only be provided after the certificate has been issued by the Notified Body and the necessary labeling adjustments and corresponding logistics plans have been made.
Changes to product labels and product information after approval by the Notified Body affect the following aspects:
- Products subject to conformity assessment by the Notified Body will display a four-digit number next to the CE mark.
- Self-declared class A products will continue to display their CE marking without the four-digit number.
- The four-digit number indicates the Notified Body that has certified the product according to IVDR. TÜV Rheinland is responsible (number 0197) is responsible for DiaSys.
- The labels show a Unique Device Identifier UDI in 2D Data Matrix code format. This includes the Global Trade Item Number (GTIN) as part of the UDI requirements.
- The package inserts will be adapted in line with the new legal requirements by adding necessary additional information.
- An exclamation mark on the label replaces the signal word and the text for special labeling, which will be stated in the package insert in the future.
- CE is omitted on the bottle label.
The ingredient composition, the performance and the intended use of the products remain identical despite visible changes to labels and package inserts. Any product modifications will be communicated to the customers via customer information like in the past.
NOTE: The sample labels shown are previews only (evaluated in January 2023). UDI Code and number of notified body will only be printed after IVDR certification.
Example kit label reagent:
Example bottle label reagent:
Example kit label control:
Example kit label calibrator:
Example bottle label control:
Example bottle label calibrator: