Carol Ryerson, Sr. Regulatory Principal Advisor
If you are reading this article you already know that the European Union recently enacted new regulations that apply to all IVD products, both currently marketed and new products not yet developed. This is the In Vitro Diagnostics Regulation (EU) 746/2017 (IVDR). The figure below outlines some key dates to keep in mind as you sort out an appropriate project plan for your IVD business.
IVDR Impact on Notified Bodies
Notified Bodies have applied for and are in the process of obtaining certification in order to issue certificates under the IVDR. If your notified body is not yet designated against the IVDR, they cannot begin to review your technical documentation. To date only 11 companies have submitted applications for IVDR designation. The initial assumption is the process would take at least 6 months with designations being issued starting in Jan 2019.
Addressing the IVDR
Now is the time to begin reviewing analytical and clinical performance data for your IVD products to insure it complies with the new regulation. The technical documentation format is new with the regulation defining several new specific plans and reports for IVD products (e.g. PEP (Performance Evaluation Plan; PER (Performance Evaluation Report); PMSP (Post-market surveillance plan); PMSR (Post-market surveillance report).
By May 2022 all of the IVD products on the market in the EU must be in full compliance with the IVDR. Final compliance will require Product Certificates in compliance with the IVDR for higher classification devices (B, C, D). For some time you may have product certificates under both the IVDD and IVDR in your portfolio. Keep in mind that all product certificates under the IVDD expire by May 2024. Communicate early and often with your notified body to understand their progress toward designation and to insure they can support your workload and timelines.
RCRI can assist with an IVDR gap assessment to help you create an appropriate project plan, as well as IVD experts to assist with updates to your IVD technical documentation on your path to compliance with the IVDR. To be put in touch with an RCRI expert, contact Samantha Spence at email@example.com or 952-224-2260.