As a European-based (EU) manufacturer of IVD products, used in clinical diagnostic laboratories throughout the world, the introduction of the EU’s IVDR is of paramount importance for ELITechGroup’s Clinical Systems division.
European Invitro Diagnostic Medical Device Regulations (IVDR) The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). IVDD required each European member state to interpret the directives and transpose them into national law. Different interpretations of IVDD gave rise to discrepancies in the regulatory framework across the EU, with global implications. The new IVDR will result in a universal, pan-European regulatory framework, which will facilitate the transfer of IVDs, not only across the EU but in the global market generally. CE mark has become a de-facto world standard for listing/registering IVD products in non-EU states and forms the basis of IVD regulations in some non-EU states. EU IVD manufacturers cannot supply goods to markets without compliance with IVDR, so becomes important for continuity of supply of IVDs for global markets. The main differences between IVDD and IVDR:
- Classification of IVD products
- Improved transparency with the inclusion of IVDs in the EUDAMED Database
- Changes to the role of Notified Bodies
- Significant increase in setup and compliance costs for manufacturers
- UDI (unique device identification system) for every IVD
- For new and existing IVDs, the information required to demonstrate compliance with the essential principles of IVDR
On the 26th of May 2017, IVDR came into force and marked the commencement of the five-year transition period, so the first deadline for the commencement of IVDR is the 26th of May 2022 IVDR compliance at ELITechGroup Clinical Chemistry ELITechGroup’s European-based manufacturing facilities in France and the Netherlands are well prepared for the commencement of IVDR. All new product developments/improvements commenced during the transition period, have been conducted in accordance with the new regulatory framework. This does not in any way change the intended use, safety, and/or performance of the IVDs supplied, however, the supply of some product lines will change, especially for those where it is not possible to meet the essential requirements, or it is not economical to do so. There are also labeling changes, e.g., updated performance data, warnings, new symbols, and specific information on limitations. As such, the implementation should not have, generally speaking, any material impact on current ELITechGroup Clinical Systems product listings or registrations. Information and details on IVDR and for those regions outside the EU zone are readily available at IVDR information for non-EU States.”
