Requiring compliance by May 2022

Although the EU began officially regulating in vitro diagnostic (IVD) products in 1993, much had changed by the time a newer, more stringent In Vitro Diagnostic Regulation (IVDR) (EU) (2017/746) was enacted more than two decades later.

A host of newly developed IVD devices and increasingly complex digital systems meant finding a better balance between two critical industry goals:

  • Encouraging continued innovation and development of novel, highly dynamic IVD technologies
  • Ensuring sufficient regulation of these technologies such that patient safety can be sufficiently protected

Recognizing that conforming to a significantly evolved standard would take significant time, Regulation (EU) 2017/746 gives manufacturers and developers within EU member states until May 2022 to meet all requirements and come into full compliance.

Expanded definition, higher standards

The IVDR aims to broaden regulatory scope and manufacturer accountability in two key ways:

  1. Redefining IVD
    • The IVD designation now includes devices categorized as “software” and “system” where specific algorithms are used in examining specimens (e.g., blood and tissue) to obtain data on disease predisposition or predictions of treatment response/reaction in patients.
  2. Tightening and standardizing regulation
    • Current EU directives allow manufacturers and developers to evaluate and CE-mark their own IVD software products. Under new IVDR rules, this policy of self-assessment would only suffice for lightly regulated, lowest-risk IVD products (Class A); most algorithm-incorporating IVDs will be assigned among three higher risk levels (Classes B, C and D), all requiring independent outside certification entities to determine compliance.

The new IVDR’s primary purpose is to clarify the obligations of manufacturers and suppliers of in vitro diagnostic products. Toward this end, IVDR seeks to:

  • Set up new, more rigorous standards for clinical evidence
  • Ensure accurate traceability throughout supply chains
  • Increase post-market vigilance and surveillance requirements
  • Bring regulation of IVDs more in line with that of medicines within the EU

Ultimately, IVDR is intended to take into account new and emergent healthcare technologies—in particular, algorithms and other code-based products—while at the same time providing a reliable framework for accountability and patient protection.

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