Tech Story

In Vitro Diagnostic Regulation (IVDR)

by EU – The Challenges

Prepared by Gautam Chakraborty Lead Assessor & Consultant, AQL Systems & Consultants, Kolkata

The EU ( EuropeanUnion ) In Vitro Diagnostic Regulation (IVDR)—formally Regulation (EU) 2017/746—announced strict rules for exporting in vitro diagnostic medical devices (IVDs) on the European market. The EU Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation (IVDR), sets out the legislative framework for placing in vitro diagnostic medical devices on the EU market. Henceforth rigorous conformity assessment for these devices must be conducted by a Notified Body (NB) to ensure the safety and effectiveness of IVD devices sold in the EU.

Based on the available literatures some of the fundamentals and the requirements of compliance obligations are discussed below.

1. What is IVDR?

The IVDR governs In Vitro Diagnostic Devices used for testing samples like blood or tissue to detect diseases, conditions, or infections (e.g., COVID tests, genetic screening).

2. Key Changes from IVDD IVDR

It replaced the older directive Directive 98/79/EC and became fully applicable on 26 May 2022, with transitional provisions

IVDR is much stricter. Major shifts include:

i. Risk-based classification system

Devices are classified into:

• Class A (low risk)
• Class B
• Class C
• Class D (highest risk, e.g., HIV tests)

ii. Stronger clinical evidence (performance evaluation)

The Manufactures / Exporters must demonstrate:

• Scientific validity
• Analytical performance
• Clinical performance

iii. Unique Device Identification (UDI)

Each device must have a traceable identifier recorded in EUDAMED.(European Database on Medical Devices)

3. Who Must Comply?

• Manufacturers (inside or outside EU)
• Authorized Representatives (for non-EU companies)
• Importers
• Distributors

Non-EU manufacturers must appoint an EU-based authorized representative.

4. Core Compliance Obligations

A. Quality Management System (QMS)

One must implement a QMS (commonly aligned with ISO 13485).

B. Performance Evaluation

A continuous process including:

• Performance evaluation plan
• Clinical evidence
• Performance evaluation report (PER)

C. Technical Documentation

One must maintain detailed documentation covering:

• Device description
• Risk management
• Manufacturing processes
• Performance data
• Labeling and instructions for use

D. Risk Management

Must be aligned with ISO 14971(The international standard for risk management of medical devices)

• Identify hazards
• Estimate and control risks
• Monitor effectiveness

E. CE Marking

To sell in the EU, the device must carry the CE mark, demonstrating IVDR compliance.

For most devices:

• Certification by a Notified Body( e.g SGS, BV, DNV etc) is required
• Conformity assessment route depends on device class

F. Person Responsible for Regulatory Compliance (PRRC)

The Exporter must designate a qualified PRRC responsible for:

• Regulatory compliance
• Documentation
• Post-market obligations

G. Post-Market Surveillance (PMS)

One must actively monitor device performance after its launch:

• PMS plan
• Periodic Safety Update Reports (PSUR) (for Class C & D)
• Vigilance reporting (serious incidents)

H. Vigilance & Reporting

The requirement specifies Reporting of a) Serious incidents&b)Field safety corrective actions (FSCAs)

within strict timelines to authorities via EUDAMED1.

I. Supply Chain Traceability

• Maintain traceability across the supply chain
• Use UDI (Unique Device Identification )system
• Maintain distribution records

5. Conformity Assessment Routes

It depends on classification of the Product :

• Class A (non-sterile) self-declaration
• Class A sterile / B / C / D Notified Body review
• Class D additional scrutiny (EU reference labs, expert panels)

6. Transitional Provisions (Important)

Devices previously certified under IVDD can remain on the market temporarily, subject to deadlines (extended into 2027–2029 depending on class).

• Class A (non-sterile) self-declaration
• Class A sterile / B / C / D Notified Body review
• Class D additional scrutiny (EU reference labs, expert panels)

7. Penalties for Non-Compliance

• Market withdrawal
• Fines
• Legal liability
• Loss of CE certification

8. Compliance Roadmap

• 1. Classify the device
• 2. Perform gap analysis vs IVDR
• 3. Implement QMS
• 4. Generate performance evidence
• 5. Prepare technical documentation
• 6. Engage Notified Body (if required)
• 7. Register in EUDAMED
• 8. Establish PMS & vigilance systems

Source:

• 1. A Step-by-Step Guide to EU IVDR Certification by SGS
• 2. ISO 14971- The international standard for risk management of medical devices
• 3. ISO 13485- The international standard that specifies requirements for a Quality Management System (QMS) specifically for manufacturers of medical devices