The IVDD to IVDR Transition: What Manufacturers Need to Know

Article Highlights

• The IVDR transition is one of the most important regulatory shifts in the history of the diagnostics industry.
• Moving from IVDD to IVDR is about more than compliance. It’s a cultural transformation.
• In this article, we cover the fundamentals of IVDR, detail the differences between IVDD and IVDR, and explain why the transition matters.

On May 26, 2022, a significant shift took place in the regulatory landscape of in vitro diagnostics (IVD) devices in the European Union (EU). The European Union’s In Vitro Diagnostic Directive (IVDD), a regulation that had governed the industry for over 20 years, was finally replaced by the In Vitro Diagnostic Regulation (IVDR). For companies that design, manufacture, or distribute in vitro diagnostic (IVD) medical devices in Europe, this isn’t just a matter of compliance. It’s about culture, trust, and quality.

In this article, we’ll cover the basics of IVDR and detail the key differences between IVDR and its predecessor, IVDD. We’ll also explain why this matters for manufacturers and discuss the steps you need to take to comply, compete, and stay trusted as an IVDR-compliant manufacturer.

Why Was IVDR Introduced?

As mentioned above, the In Vitro Diagnostic Directive (IVDD) has been the standard in vitro regulation in the European Union (EU) for over two decades. During that time, it established a broad framework for IVD device classification, clinical evidence requirements, performance evaluation, and post-market surveillance. Its successor, the In Vitro Diagnostic Regulation (IVDR), replaces it. There are significant differences between IVDD and IVDR, but first, it’s important to understand why IVDR was needed.

The IVDD laid out some important safety and performance standards but left a lot of room for interpretation. This meant that European Union (EU) member states could and did define the details of IVDD compliance within their national legislations in ways that didn’t always align. As a result, manufacturers looking to sell their products in multiple EU countries had to jump through many different hoops to achieve compliance.

Meanwhile, diagnostic technology was improving by leaps and bounds. Advances in genetic testing, high-risk infectious disease diagnostics, and molecular diagnostics made these tests more common and more complex. But devices were still being developed and classified in frameworks that dated back to an earlier era.

Diagnostic technologies were also evolving quickly. New tools for genetic testing, infectious disease diagnostics, and molecular testing were being introduced at an ever-increasing rate. At the same time, we were seeing more emphasis on patient safety and data transparency from both regulators and the public. The IVDR was designed to align with these emerging trends and needs.

What Is the IVDR?

IVDR is short for the In Vitro Diagnostic Regulation. It’s a legally binding regulation that defines how to classify, document, evaluate, and monitor in vitro diagnostic (IVD) devices. That includes everything from basic laboratory tests to advanced high-risk genetic tests. As of May 26, 2022, it applies to all IVD devices being marketed in Europe, regardless of where the manufacturer is based.

Manufacturers, notified bodies, distributors, importers, and authorized representatives must all ensure that they fully comply with IVDR requirements, which are both more specific and more rigorous than those in the old IVDD framework.

The IVDR mandates stricter requirements for many areas, including:

• Clinical evidence for device approval
• Rigorous oversight for higher-risk devices
• Transparency, including publishing clinical data

The new regulation doesn’t just ensure legal compliance; it builds a foundation of trust, patient safety, and long-term performance.

The Difference Between IVDD and IVDR

To understand the difference between IVDD and IVDR, it’s important to grasp the fundamental shift in the underlying regulatory philosophy.

The shift from IVDD to IVDR reflects a fundamental change in how the European Union (EU) is approaching medical device regulation.

IVDD (Directive) IVDR (Regulation)

Flexible, open to national interpretation Strictly defined, uniform across the EU

Allows deviation in implementation Requires full compliance for all member states

Symbolically, the changes matter. Directives can be loosely transposed into national law, with variations between EU member states. Regulations are binding laws that must be adopted in the same form by all member states. In short, the goal of the IVDR is to create a single standard that is enforced the same in Germany as it is in Greece.

Risk-Based Classification System

Arguably, the biggest change for manufacturers is the shift to a risk-based classification system. Under IVDD, most IVD device classification was based on self-declaration. Manufacturers could and did broadly categorize their devices on their own. If notified bodies or regulators later discovered errors, they might face penalties, but in many cases, issues were only detected post-market.

Under IVDR, there is now a four-tiered classification system, ranging from the lowest-risk (Class A) to the highest-risk (Class D). Class A devices are the only ones that do not require oversight by notified bodies, and in practice, the only ones that still use self-declaration. All other devices are assessed according to the following framework:

• Class A – Lowest risk (non-risky general purpose laboratory instruments).
• Class B – Moderate risk
• Class C – High risk
• Class D – Highest risk

Class D devices, such as HIV tests and blood safety tests, are subject to the most stringent oversight and transparency requirements. Class C devices, including complex infectious disease tests and certain genetic tests, also face increased scrutiny. Only Class A non-sterile devices (for instance, general lab equipment) can self-declare. All other devices must have notified body review and oversight.

In addition to the added burden of increased scrutiny and involvement of notified bodies, the IVDR also classifies devices differently and more stringently.

New Manufacturer Requirements in IVDR

Transitioning from IVDD to IVDR involves more than reclassifying your products according to the new standards. There are also a host of new obligations that affect all manufacturers and commercial stakeholders in IVD devices.

Post-Market Surveillance (PMS)

In the IVDR, manufacturers must have a process for post-market surveillance to ensure that the devices are being used and performing as expected.

Unique Device Identification (UDI)

The IVDR mandates a unique device identification (UDI) process. Every device must be assigned a unique identifier for traceability across the supply chain.

Notified Body Involvement

Except for Class A devices, manufacturers are required to get their products reviewed by notified bodies.

Performance Evaluations

Clinical data must be provided to demonstrate the safety and efficacy of devices.

Defined Roles for All Economic Operators

The roles of all stakeholders, including manufacturers, distributors, importers, and authorized representatives, are much more clearly defined in the IVDR. Compliance with these new requirements can significantly increase the costs and complexity of getting devices to market.

A final note on classification: There are four risk-based classes of IVD devices. Class A is the lowest risk, while Class D is the highest. Only Class A non-sterile devices are exempt from notified body requirements. All other devices must be reviewed and evaluated by notified bodies.

Why This Matters

On the surface, the shift from IVDD to IVDR is all about compliance. It’s not. While transitioning from IVDD to IVDR is about compliance, it’s also much more.

For patients

Patient safety, transparency, and access to better data

For manufacturers

Stronger competition, accountability, innovation

For regulators

Simplified oversight, reduced fragmentation

IVDR offers an opportunity to build a better, more transparent, more competitive, and more trusted future for the IV industry in Europe. For companies willing to invest in regulatory, quality, and legal functions and take an adaptable, compliance-first approach to IVD design and production, IVDR compliance can offer more than just clearance. It can provide an edge.

Adapt to stay competitive

The transition from IVDD to IVDR isn’t just a regulatory change. It’s a chance for diagnostic manufacturers to adapt, innovate, and differentiate themselves in a rapidly changing industry. Here’s what manufacturers need to know:

IVDR Isn’t an Obstacle Course; It’s a Benchmark

The shift from IVDD to IVDR isn’t an endpoint. It’s a floor, not a ceiling. The new regulation sets a minimum standard, so now is the time for manufacturers to consider how to exceed the minimum. To become leaders, not laggards.

Be Transparent, From Start to Finish

Visibility and transparency are key elements of the IVDR. Manufacturers who are already engaged with IVDR and invest in full transparency will stand out. They will have an edge when the EU starts to seriously enforce some of the new requirements in 2024.

Evolving Regulations, Evolving Strategies

IVDR compliance is not a destination; it’s a journey. Regulations will continue to evolve and mature as they move from theory to practice. Manufacturers who remain adaptable and compliant will have a strategic advantage.

Act Now, Not Later

Many companies are in a wait-and-see mode. We recommend doing the opposite. Waiting only compounds problems and costs. The longer you wait to get started, the more behind you’ll be.

Look for Partners, Not Burdens

The transition to IVDR doesn’t have to be an internal process. Partnerships with regulatory, quality, and compliance experts can ease the burden on your team, accelerate your progress, and help you become an IVDR leader.

Empathy for Compliance

The shift from IVDD to IVDR can be an exciting time for forward-thinking companies who are ready to break out of their old compliance silos. By making compliance a shared goal and investment across the organization, manufacturers can accelerate the transition, reduce uncertainty, and create a strategic advantage in the new IVDR world.

Act Now to Lead Later

We expect to see many companies launch an IVDR compliance effort later this year. The ones who beat the crowd will be in the best position to win.

Legacy Solutions, Legacy Problems

The next generation of IVDR software solutions is here. If you still use legacy platforms, you will be slower to adapt and further behind when the time to act finally arrives.

Do the Work, Get the Edge

Companies that take a proactive, quality-first approach to IVDR compliance will not only have an easier time, they will have an edge. In the long run, time is money, and in many cases, starting early can pay dividends down the road.

Conclusion

The transition from IVDD to IVDR is a turning point in the history of the diagnostics industry in Europe. In this article, we covered:

• IVDR basics
• IVDD vs IVDR
• Transition strategies
• Why this matters

Companies that act early and act now, taking a strategic and adaptable approach to the transition, will be in the best position to lead once the EU starts to take the IVDR seriously. To learn more about Language Scientific’s IVDR translation services click here.