{"id":6244,"date":"2026-05-08T17:56:14","date_gmt":"2026-05-08T12:26:14","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6244"},"modified":"2026-05-09T14:34:25","modified_gmt":"2026-05-09T09:04:25","slug":"how-to-get-legacy-devices-to-ivdr-compliance","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/om-en\/how-to-get-legacy-devices-to-ivdr-compliance\/","title":{"rendered":"How to Get Legacy Devices to IVDR Compliance"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

How to Get Legacy Devices to IVDR Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR Compliance) marks a significant regulatory overhaul for manufacturers in the EU market. Legacy IVD devices those already placed on the market under the IVDD must now meet stricter requirements under the IVDR (EU 2017\/746) to maintain market access.\u00a0<\/span><\/p>

If you\u2019re a manufacturer of legacy devices, this blog will help you understand how to achieve IVDR compliance within the transitional timelines. Failing to comply may result in the device being pulled from the EU market, impacting business continuity and patient safety. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t

What Are Legacy IVD Devices?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Legacy devices refer to in vitro diagnostic devices that were CE marked under the IVDD and are still being made available or placed on the EU market during the IVDR transition period. These devices benefit from a grace period, provided they do not undergo significant changes in design or intended use.\u00a0<\/span><\/p>

Also read our blog on: <\/strong>EU MDR Compliance for Legacy Devices<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t

Steps to Make Your Legacy Devices IVDR Compliant\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t
  1. Engage Early with a Notified Body\u00a0<\/strong><\/li><\/ol>

    Delays in Notified Body availability could derail your compliance timeline. Initiate dialogue and submit your application early to avoid bottlenecks.\u00a0<\/span><\/p>

    1. Appoint a Person Responsible for Regulatory Compliance (PRRC)\u00a0<\/strong><\/li><\/ol>

      The IVDR mandates a designated PRRC to oversee compliance activities. Ensure the appointed individual has the required qualifications and experience.\u00a0<\/span><\/p>

      Please read our blog on: <\/strong>Understanding the PRRC under EU MDR and IVDR<\/span><\/a><\/p>

      1. Update Technical Documentation<\/strong>\u00a0<\/span><\/li><\/ol>

        Your documentation must now include:\u00a0<\/span><\/p>