By Adaptive Life Science

The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) — Regulation (EU) 2017/746 — represents one of the most significant regulatory overhauls in the diagnostics sector in decades. Officially applicable since 26 May 2022, the IVDR replaces the previous Directive 98/79/EC, introducing a more robust, transparent, and risk-based framework for ensuring the safety and performance of in vitro diagnostic (IVD) medical devices across the EU.

As a recruitment partner to the medical device, IVD, and biotech industries, Adaptive Life Science is committed to helping our clients and candidates stay informed and prepared. This article outlines the key aspects of the IVDR and what companies need to know to remain compliant and competitive.

Why IVDR Matters

The IVDR was introduced to address gaps in the previous directive, particularly in light of rapid technological advancements and the need for stronger oversight. It aims to:

• Improve patient safety and device performance.
• Introduce a risk-based classification system.
• Strengthen conformity assessments and post-market surveillance.
• Increase transparency and traceability through systems like Eudamed and UDI.

Key Changes Under IVDR

1. New Risk-Based Classification System

Devices are now classified into four risk classes: A (lowest risk), B, C, and D (highest risk). This replaces the previous one-size-fits-all approach and aligns with international standards.

• Class A: Low risk (e.g., specimen receptacles).
• Class B & C: Moderate to high risk (e.g., pregnancy tests, infectious disease tests).
• Class D: Highest risk (e.g., HIV, hepatitis, blood grouping tests).

2. Greater Role of Notified Bodies

Under the IVDR, most IVDs now require Notified Body involvement — a major shift from the previous regime where only ~20% of IVDs required such oversight. Now, it's estimated that 80–90% of IVDs fall under this requirement.

3. Stricter Performance Evaluation Requirements

Manufacturers must provide scientific validity, analytical performance, and clinical performance data. This includes a performance evaluation plan and ongoing post-market performance follow-up.

4. Enhanced Post-Market Surveillance

Manufacturers are required to implement a Post-Market Surveillance (PMS) system that actively collects and evaluates data on device performance and safety throughout its lifecycle.

5. Unique Device Identification (UDI)

A UDI system is now mandatory for all devices (except those used in performance studies), improving traceability and enabling faster responses to safety issues.

6. Eudamed Database

The European Database on Medical Devices (Eudamed) centralizes information on devices, manufacturers, certificates, clinical studies, and vigilance reports. It enhances transparency and coordination among stakeholders.

Transition Periods and Deadlines

Due to the complexity of the regulation and the COVID-19 pandemic, the EU extended transition periods based on device classification:

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

These extensions apply only to legacy devices that were already on the market under the previous directive and meet specific conditions.

What This Means for Employers and Candidates

For Employers:

• Regulatory expertise is in high demand. Companies need professionals with IVDR experience, especially in regulatory affairs, quality assurance, and clinical affairs.
• Hiring timelines may be impacted by the need for additional documentation, audits, and notified body interactions.
• Strategic workforce planning is essential to meet compliance deadlines and avoid market disruptions.

For Candidates:

• If you have experience with IVDR, ISO 13485, or notified body interactions, your skills are highly sought after.
• Roles in regulatory affairs, clinical evaluation, and quality systems are growing rapidly.
• Adaptive Life Science offers free career support to help you navigate this evolving landscape.

Contact Adaptive Life Science Recruitment

Final Thoughts

The IVDR is reshaping the IVD and medical device industry in Europe. While the regulation introduces significant challenges, it also presents opportunities for innovation, improved patient outcomes, and professional growth.

At Adaptive Life Science, we’re here to support both companies and candidates through this transition. Whether you're building a compliant team or looking to advance your career in this space, we’re ready to help.

Contact Adaptive Life Science Recruitment