Section 1: Introduction

Are You Ready for the IVDR Changes?

If you currently market and sell in vitro diagnostic medical devices in the European Economic Area (EEA) or are planning to do so in the near future—now is the time to get up to speed with the new In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure compliance.

Published on May 25, 2017, the IVDR 2017/746^1,2 introduced an expansive set of new rules for how in vitro diagnostic devices are regulated in the European Union (EU). The goal was to replace decades-old legislation with regulations that are more in line with the latest technological advances and medical science and create a more transparent regulatory framework that helps improve patient safety.

The new regulation provides stricter oversight in many areas as compared to the EU’s previous In Vitro Diagnostic Medical Device Directive (IVDD).

Some noteworthy changes include:

• Greater emphasis on the entire product lifecycle as opposed to just the pre-approval stage 

• Expanded definition of in vitro diagnostic device to include genetic testing and software 

• New risk-based classification system for in vitro diagnostic devices 

• Greater emphasis on post-market surveillance 

• More stringent requirements for clinical evidence 

• Greater supervision over notified bodies

Effective May 26, 2022, new devices must be certified and existing devices recertified under the new IVDR. This will require manufacturers to revisit their quality management system (QMS) and update core processes to ensure compliance. Ultimately, manufacturers that fail to comply with the IVDR could face costly fines, litigation, design changes, product recalls, or lack of access to the EU market.

Navigating the new regulation and figuring out where to start can be daunting. In this guide, we highlight the new IVDR requirements that will have the greatest impact on your quality management processes and product portfolio. We also provide the key steps to making a successful IVDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

Important Dates for EU IVDR Transition

Manufacturers will need to recertify existing devices and certify new devices according to this timeline:

EXTENDED TRANSITION PERIOD FOR CERTAIN IN VITRO DIAGNOSTIC DEVICES

On March 20, 2023, the European Commission issued Regulation (EU) 2023/607, which provides an extension period for devices that were self-declared (i.e., no notified body involvement) under the EU’s previous In Vitro Diagnostic Medical Device Directive (IVDD) as follows:

• Class D devices: May 26, 2025
• Class C devices: May 26, 2026
• Class B and Class A sterile devices: May 26, 2027

Furthermore, the sell-off date for IVDD-certified devices that were already placed on the market has been removed, enabling these devices to remain available for purchase in the EU.

Arena QMS Tip: Custom Attributes and Arena Training

To keep track of upcoming certification dates for your medical devices, create a next-due-date custom attribute for each product and generate a report. Also assign product certification due dates to training plans so that owners receive automatic reminders.