An Overview of the In Vitro Diagnostic Regulation (IVDR)

IVDR Made Simple: Your Beginner’s Guide to Europe’s New Diagnostic Rules
The IVDR (In Vitro Diagnostic Regulation – EU 2017/746) is the European Union’s new law that controls the safety and quality of in-vitro diagnostic devices tests and instruments used to examine human samples like blood, urine, or tissue. It replaced the older IVDD in 2022 and introduced much stronger rules to protect patients. IVDR demands better performance data, more transparency, and continuous monitoring of devices after they reach the market. One of the biggest changes is the risk-based classification system. Every device now falls into Class A, B, C, or D based on how risky it is to patients. Most devices (Classes B, C, D) now need approval from a Notified Body, unlike the old system where many companies could self-certify. IVDR also requires detailed technical documentation, strong clinical and analytical evidence, and a proactive post-market surveillance system to track device performance in real-world use. For manufacturers, IVDR is important because non-compliance means losing access to the EU market one of the world’s largest healthcare markets. The regulation improves safety, strengthens brand credibility, and brings EU rules closer to global standards. Manufacturers must update their quality systems, labels, UDI codes, performance evaluation reports, and register their devices in EUDAMED, the EU’s central database. Overall, IVDR creates a stricter but safer environment for patients and the diagnostics industry. With clear timelines, new documentation rules, and the need to work closely with Notified Bodies, companies must plan early and maintain strong compliance to keep their products on the EU market.

IVDR Made Simple: Your Beginner’s Guide to Europe’s New Diagnostic Rules

The IVDR (In Vitro Diagnostic Regulation – EU 2017/746) is the European Union’s new law that controls the safety and quality of in-vitro diagnostic devices tests and instruments used to examine human samples like blood, urine, or tissue. It replaced the older IVDD in 2022 and introduced much stronger rules to protect patients. IVDR demands better performance data, more transparency, and continuous monitoring of devices after they reach the market.

One of the biggest changes is the risk-based classification system. Every device now falls into Class A, B, C, or D based on how risky it is to patients. Most devices (Classes B, C, D) now need approval from a Notified Body, unlike the old system where many companies could self-certify. IVDR also requires detailed technical documentation, strong clinical and analytical evidence, and a proactive post-market surveillance system to track device performance in real-world use.

For manufacturers, IVDR is important because non-compliance means losing access to the EU market one of the world’s largest healthcare markets. The regulation improves safety, strengthens brand credibility, and brings EU rules closer to global standards. Manufacturers must update their quality systems, labels, UDI codes, performance evaluation reports, and register their devices in EUDAMED, the EU’s central database.

Overall, IVDR creates a stricter but safer environment for patients and the diagnostics industry. With clear timelines, new documentation rules, and the need to work closely with Notified Bodies, companies must plan early and maintain strong compliance to keep their products on the EU market.

What is IVDR (EU 2017/746)

IVDR (In Vitro Diagnostic Regulation) is the EU regulation that sets requirements for the safety, performance, and quality of in vitro diagnostic medical devices, replacing the earlier IVDD in May 2022. replacing the earlier In Vitro Diagnostic Device Directive 98/79/EC.

which include tests and instruments used to examine human samples such as blood, tissue, or urine. The IVDR strengthens requirements for safety, performance, transparency, and post-market surveillance of IVD Devices.

Its introduction marks a significant shift in the regulatory landscape for IVD manufacturers, aiming to increase patient safety and regulatory harmonization across the EU. The IVDR also introduces a risk-based classification system, tighter requirements for clinical evidence, and increased oversight by Notified Bodies, making it a much more accurate framework than the previous directive.

The Importance of IVDR Compliance for IVD Manufacturers

Failing to comply with the IVDR means losing access to the EU market one of the world’s largest healthcare markets. The regulation introduces stricter safety and performance standards, which help protect patients from faulty or misleading diagnostic devices.

Here’s why IVDR compliance matters:

Market Access: Products that fail to comply cannot be legally placed on the EU market.
Risk Mitigation: Compliance helps prevent regulatory sanctions, costly recalls, and potential harm to brand reputation.
Credibility & Trust: Strengthens clinical confidence in your product.
Global Alignment: IVDR aligns with international expectations for IVD regulation, making it easier to approach other markets.

In short, compliance is not just a legal requirement – it’s a competitive necessity.

Major Changes: IVDD vs. IVDR

The IVDR brings a more stringent and structured regulatory framework compared to the IVDD. Here are the most notable changes:

Aspect

IVDD (98/79/EC)

IVDR (2017/746)

Classification

Classification is list-based. Annex II (List A & List B) specifies which devices require Notified Body involvement; most others are self-certified.

Reference: Directive 98/79/EC, Annex II (Lists A & B).

Moves to a risk-based system with Classes A, B, C, D.

Reference: Regulation (EU) 2017/746, Article 47 and Annex VIII.

Notified Bodies

Limited role. Only Annex II List A, List B, and self-testing devices required NB involvement.

Reference: Directive 98/79/EC, Annexes III–VII (conformity assessment routes).

IVDs were self-certified and NB involvement was limited. IVDR now mandates that all IVDs classified as Class B, C, or D require conformity assessment by a Notified Body

Reference: Regulation (EU) 2017/746, Articles 48–51, Annex IX–XI (conformity assessment).

Performance Evaluation

Minimal requirement: device must achieve intended performance as declared by the manufacturer.

Reference: Directive 98/79/EC, Annex III, 6 (The manufacturer shall ensure that the device achieves the performances. which the manufacturer has claimed for it).

Requires full performance evaluation, covering:

Scientific validity
Analytical performance
Clinical performance

Documented in a Performance Evaluation Report (PER).

Reference: Regulation (EU) 2017/746, Articles 56–58, Annex XIII.

Technical Documentation

Basic technical file requirements, less detailed.

Reference: Directive 98/79/EC, Annex III (EC declaration of conformity) and Annex IV–VII.

Highly detailed, must cover: device description, risk management, benefit-risk analysis, clinical evidence, PMS, etc.

Reference: Regulation (EU) 2017/746, Article 10(4), Annex II & III.

Post-Market Surveillance

Vigilance was reactive (manufacturers notified authorities of incidents). No detailed PMS obligations.

Reference: Directive 98/79/EC, Article 10 (incident reporting).

Requires a proactive PMS system, including:

PMS plan (Article 79)
PMS report (Article 80)
PSUR (Periodic Safety Update Report) for Classes C & D (Article 81)
Trend reporting and vigilance (Article 82–87).

Reference: Regulation (EU) 2017/746, Articles 78–87, Annex III.

These changes reflect a broader push for transparency, lifecycle management, and evidence-based evaluation of IVDs.

What Devices Fall Under IVDR

The IVDR covers a wide range of products used to examine specimens from the human body for medical purposes. Devices under its scope include:

General IVDs: Blood glucose meters, pregnancy tests, lab reagents
Self-Testing Devices: HIV self-tests, COVID-19 test kits
Companion Diagnostics: Tests used to determine treatment eligibility (e.g., HER2 testing for breast cancer)
Genetic Tests & Screening Tools
Software: Applicable when it controls, supports, or impacts the functionality or interpretation of an IVD.

Manufacturers should assess both the intended use and risk level to determine classification under IVDR, as the scope is broader and more nuanced than under IVDD.

Summary of Key Amendments to IVD Regulations

Several supplementary regulations have been introduced to provide stakeholders with more time and clarity to ensure continued access to in vitro diagnostic devices in the EU market.

Regulation	Main Highlights
(EU) 2022/112	– Initial extension of transition timelines for legacy IVDs – Transition periods introduced based on risk classification of devices
(EU) 2023/503	– Increased intervals for periodic review of notified bodies
(EU) 2023/607	– Elimination of the sell-off period for devices already on the market during the transitional phase
(EU) 2024/1860	– Further extension of transitional timelines – Introduction of timelines for setting up a compliant quality management system under IVDR – Defined deadlines for signing and completing agreements with notified bodies – Gradual implementation of the EUDAMED system – Requirement to inform authorities in advance about planned discontinuation of device supply

Classification of IVDs Under IVDR

One of the major shifts introduced by the IVDR is the adoption of a risk-based classification system, replacing the list-based model used under the IVDD. Under IVDR, in vitro diagnostic devices are categorized into four risk classes:

Class A: Low-risk devices (e.g., laboratory instruments, sample containers)
Class B: Moderate-risk devices (e.g., pregnancy tests, CRP tests)
Class C: High-risk devices (e.g., infectious disease tests like Hepatitis B)
Class D: Highest-risk devices (e.g., HIV or blood group tests used for transfusions)

The classification depends on factors such as intended use, potential impact on patient or public health, and the importance of the information provided. This system aligns with global standards and ensures proportional scrutiny based on the device’s risk.

Role and Importance of Notified Bodies

Under the IVDR framework, Notified Bodies (NBs) play a significantly expanded and critical role in the conformity assessment of In Vitro Diagnostic (IVD) devices. This is a major shift from the IVDD (Directive 98/79/EC), where most IVDs were self-certified and NB involvement was limited. IVDR now mandates that all IVDs classified as Class B, C, or D require conformity assessment by a Notified Body, with only limited exemptions for Class A non-sterile devices.

Regulatory Basis

As per Article 48(10) of Regulation (EU) 2017/746:

Manufacturers of Class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III.

Roadmap to IVDR Compliance

Achieving IVDR compliance is a multi-step process that requires careful planning, documentation, and quality system upgrades. Here’s a simplified roadmap:

Conduct a Gap Assessment: Start by reviewing your current systems, technical files, QMS, and product claims. Compare them with IVDR requirements. This step doesn’t refer to a specific Annex but helps identify gaps related to Annex II (Technical Documentation), Annex III (Post-Market Surveillance), Annex VIII (Classification), and conformity assessment Annexes (IX, X, XI).

Reclassify Devices: Every IVD must now be classified into risk Classes A, B, C, or D based on intended use and risk to the patient. This is a shift from the list-based classification under IVDD.

Annex VIII – Details classification rules.
Article 47 – Introduces the risk-based classification approach.

Only Class A (non-sterile) can be self-declared; Classes B–D require a Notified Body.

Update Technical Documentation: You must update the technical file to match the new structure and requirements.

Annex II – Describes the required contents of technical documentation.
Annex III – Adds PMS documentation requirements (e.g., PMS Plan, PMS Report, PSUR).

Ensure your documentation clearly demonstrates safety, performance, and benefit-risk balance.

Strengthen the Quality Management System (QMS): Ensure your QMS complies with ISO 13485:2016 and integrates IVDR-specific obligations.

Article 10(8) – Obligates manufacturers to establish and maintain a compliant QMS.
Annex IX / XI – QMS assessment is part of the conformity procedures involving Notified Bodies.

NBs will assess your QMS as part of the conformity assessment process.

Engage a Notified Body: Select and contract a Notified Body (NB) whose designation covers your device type.

Article 48 – Outlines when NB involvement is required.
Annex IX / X / XI – Different routes for conformity assessment, depending on the classification and documentation strategy.

Early engagement is critical due to limited NB capacity.

Compile Performance Evaluation Data: Performance Evaluation must be evidence-based and cover three pillars To understand every requirement of IVDR performance evaluation, read our dedicated articles:

Scientific Validity Report – explains how to demonstrate the scientific rationale behind your IVD.
Analytical Performance Report – covers analytical verification, including precision, sensitivity, and limits of detection.
Clinical Performance Report – details how to establish clinical evidence for intended use.
Annex XIII – Sets out requirements for performance evaluation and the Performance Evaluation Report (PER).

This is a core evidence requirement under IVDR.

Prepare PMS and Vigilance Plans: You must proactively monitor and analyze device performance after it’s on the market.

Annex III – Covers PMS plan structure and PSUR requirements.
Articles 78 to 81 – Detail PMS requirements based on classification (e.g., PMS Reports for Class A/B and PSUR for Class C/D).

PMS is no longer optional – it’s mandatory, structured, and risk-based.

Appoint Economic Operators: If you’re not located in the EU, appoint an EU Authorised Representative (EC REP) and define responsibilities with importers and distributors.

Article 11 – EU Authorised Representative
Article 13 – Importer responsibilities

You must ensure full traceability and compliance through your supply chain.

Labelling & UDI Compliance: Update your device labels and packaging to meet new GSPR and UDI requirements.

Annex I, Section 20 – Covers general label and information obligations.
Annex VI – Defines the structure and application of UDI (Unique Device Identifier).

UDI ensures traceability and must be registered in EUDAMED.

Submit for Conformity Assessment: Once all documentation is ready, submit your application to the Notified Body.

Annex IX, X, XI – Depending on your conformity assessment path.
CE marking must follow NB review and approval for Class B, C, and D.

Class A non-sterile devices can self-certify, but others need full NB review.

Performance Evaluation Requirements

Performance evaluation under IVDR is mandatory for all IVD classes, and it is detailed in Annex XIII along with Articles 56,57,58.

Scientific Validity: The link between the analyte and the clinical condition (e.g., gene mutation and disease risk).
Analytical Performance: The ability of the test to accurately detect or measure the analyte.
Clinical Performance: How well the test performs in real-world clinical settings, including sensitivity, specificity, and clinical utility.

As detailed in our recent blog , PMPF activities play a pivotal role in providing real-world evidence that strengthens the Performance Evaluation Report (PER), ensuring the ongoing safety and effectiveness of the device.

Technical Documentation Under IVDR

Under IVDR, the technical documentation (also referred to as the technical file) is more detailed and structured than under the previous directive. It must follow the format outlined in Annex II and Annex III of the regulation (EU) 2017/746.

Key elements include:

Device description and specification
Design and manufacturing information
Labelling and IFU samples
Risk management documentation
Performance evaluation documentation
PMS and PMPF plans
UDI assignment and traceability
Declarations of conformity and certificates

This documentation must be kept up to date and available for review by the Notified Body and Competent Authorities. Proper structure and completeness are critical for timely approvals.

Post Market Surveillance (PMS) & Vigilance Obligations

The IVDR requires manufacturers to implement a proactive, risk-based PMS system for every device. This system must be designed to monitor real-world performance, detect risks early, and implement corrective actions where needed.

Core PMS elements include:

Post-Market Surveillance Plan (Annex III Part B)
Periodic Safety Update Report (PSUR) – mandatory for Class C and D
Trend reporting of non-serious incidents and near-misses
Incident reporting to competent authorities
Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)

These processes ensure continuous compliance and patient safety across the entire device lifecycle.
As detailed in our recent blog, PMS activities under IVDR 2017/746 play a pivotal role in continuously and systematically gathering, recording, and analyzing real-world data to confirm the safety, performance, and clinical benefit of the device throughout its lifecycle.

IVDR Timelines & Deadlines

While IVDR became fully applicable on May 26, 2022, many manufacturers are still within a grace period depending on their device type and certification status under IVDD.

Key dates to know:

Device Category	Old Deadline	New Deadline
Class D devices	26 May 2025	31 December 2027
Class C devices	26 May 2026	31 December 2028
Class B devices	26 May 2027	31 December 2029
Class A sterile devices	26 May 2027	31 December 2029
Class A non-sterile devices	Already under IVDR (from 26 May 2022)	Already under IVDR (from 26 May 2022)
New devices / devices with significant change	Already under IVDR (from 26 May 2022)	Already under IVDR (from 26 May 2022)

Language & Labelling Requirements under IVDR

Labelling (Chapter III, Section 20.2) and language requirements (Article 37) are more stringent under the IVDR to support patient safety and traceability across the EU.

Labelling must include:

UDI-DI and UDI-PI codes in compliance with Annex VI.
Name/trade name of the device.
Manufacturer’s name, registered trade name/mark, and address (plus an Authorized Representative’s details if applicable).
Importer’s contact information (if device is placed on the EU market by an importer).
Lot number or serial number (for traceability).
Date of manufacture or expiry date, where applicable.
Special storage and/or handling conditions, if required.
Sterile indicator and method of sterilization (if applicable).
Warnings, precautions, or limitations that are necessary for safe use.
Intended purpose of the device.
Symbols as per harmonized standards (EN ISO 15223-1), ensuring clarity without translation where possible.

Language considerations: Article 37 (Language requirements)

Translation into official EU languages: All instructions for use (IFUs), labels, and safety information must be provided in the official language(s) of the EU Member State where the device is made available to the user or patient.
Clear and understandable: The language used must be clear, unambiguous, and easily understood by the intended user, whether a layperson or healthcare professional.

EUDAMED Requirements

EUDAMED (European Database on Medical Devices) is the central EU IT system created to increase transparency and improve coordination of information regarding medical devices and in vitro diagnostic devices (IVDs). Under IVDR, EUDAMED is the key platform where information is registered, exchanged, and monitored by manufacturers, Authorized Representatives, importers, distributors, Notified Bodies, and Competent Authorities.

Core Requirements in IVDR

The IVDR (Regulation (EU) 2017/746) establishes obligations for EUDAMED mainly in Articles 25 to 34 and related Annexes. The main requirements are:

Actor Registration

Manufacturers, Authorized Representatives, and Importers must register in EUDAMED.
Each actor receives a Single Registration Number (SRN) for unique identification.
Reference: Article 28.

UDI Database

Unique Device Identification (UDI) details must be uploaded to EUDAMED.
Manufacturers must register the UDI-DI (Device Identifier) and related device information.
Reference: Articles 24 to 27, Annex VI.

Device Registration

Every IVD placed on the EU market must be registered in EUDAMED.
Information includes: device identifier, risk class, intended purpose, manufacturer details, and certificates.
Reference: Article 26.

Certificates and Notified Body Information

Certificates issued by Notified Bodies (NBs) must be uploaded to EUDAMED.
This ensures transparency and traceability of conformity assessments.
Reference: Article 51(5).

Clinical / Performance Study Data

EUDAMED hosts a module for registering clinical performance studies of IVDs.
This includes applications, approvals, amendments, and results.
Reference: Articles 57 to 77.

Post-Market Surveillance (PMS) and Vigilance

Manufacturers must report serious incidents, field safety corrective actions (FSCAs), trend reports, and PSURs into EUDAMED.
Competent Authorities and the Commission use this data for monitoring and safety analysis.
Reference: Articles 82 to 87.

Market Surveillance by Authorities

Competent Authorities record their market surveillance activities (e.g., inspections, audits, enforcement actions) in EUDAMED.
Reference: Article 93 to 100.

Conclusion

The EU IVDR sets a new benchmark for safety, transparency, and market access. With stricter requirements for classification, performance evaluation, technical documentation, post-market surveillance, and EUDAMED registration, early planning is key. Morulaa Healthtech helps manufacturers meet these demands with end-to-end support from device reclassification and documentation updates to EUDAMED registration and Notified Body coordination. Partner with us to navigate the IVDR transition smoothly and ensure your IVDs reach the EU market fully compliant and on schedule.