The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices—tests and instruments used to examine human samples like blood or tissue. The IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and introduces significantly more stringent requirements for clinical evidence, quality systems, performance evaluation, and post-market surveillance.
For manufacturers, understanding the IVDR is essential for maintaining or gaining access to the EU market.
Why the IVDR Matters
Under the older IVDD, only about 20% of IVDs required Notified Body review. Under the IVDR, that number jumps to nearly 80–90%, dramatically increasing the regulatory burden for most manufacturers.
The regulation aims to:
Key Requirements Under IVDR
The IVDR introduces new expectations that affect every stage of product development and maintenance:
1. Classification System
Devices are now classified into four risk categories (A–D) based on intended use and risk to patients and the public. Higher-risk classes (C and D) require Notified Body involvement and greater clinical evidence.
2. Performance Evaluation
Manufacturers must provide robust analytical and clinical performance data, as well as evidence of scientific validity, to demonstrate safety and performance.
3. Technical Documentation
The technical file must clearly demonstrate conformity with IVDR requirements and include:
4. Quality Management System (QMS)
A compliant ISO 13485-based QMS is essential to ensure ongoing conformity, covering areas such as supplier control, complaint handling, and vigilance reporting.
5. Notified Body Review and CE Marking
Before a device can be marketed in the EU, it must undergo conformity assessment through a designated Notified Body (for all but the lowest-risk Class A devices). Once approved, the product may bear the CE mark indicating compliance.
Transition Periods and Deadlines
While the IVDR officially took effect in May 2022, many legacy IVDs benefit from staggered transition timelines depending on device class and certification status. Manufacturers should closely track EC guidance and Notified Body capacity, as delays in review can affect market access.
Even for devices under transitional provisions, proactive gap assessments and technical file updates are essential to prevent business disruption.
Common IVDR Compliance Challenges
Manufacturers often struggle with:
Working with experienced regulatory partners can help identify documentation gaps early and maintain compliance continuity.
How GLOBAL Can Help
At GLOBAL, we help device manufacturers meet IVDR requirements efficiently and confidently. Our regulatory writers and consultants can:
Whether you need targeted document support or end-to-end regulatory strategy, GLOBAL is your partner for navigating the complexities of the IVDR.
Partner With Experience That Delivers
The IVDR raises the bar for compliance—but with the right guidance, you can meet it.
Our team combines deep scientific knowledge with regulatory expertise to help you maintain market access and achieve full conformity with EU requirements.
Contact us today to learn how GLOBAL can streamline your IVDR submissions and ensure your diagnostic products meet every requirement for safety, performance, and success.
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices—tests and instruments used to examine human samples like blood or tissue. For manufacturers, understanding the IVDR is essential for maintaining or gaining access to the EU market.
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