1. What is the IVDR EU 2017/746 ?

The In Vitro Diagnostic Regulation is a rule by EU Regulation. It sets requirements for the safety, performance and quality of devices that test human samples, like blood, tissue or urine. This regulation replaced the old In Vitro Diagnostic Directive regulation in May 2022. The IVDR makes the rules for safety, performance, transparency and checking products after they are on the market much stronger.

The In Vitro Diagnostic Regulation helps keep patients safe and makes regulations the same across the EU MDR Consultant. The IVDR also has a system to classify risks, stricter rules for clinical evidence and more oversight by Notified Bodies.

2. The Importance of IVDR Compliance for IVD Manufacturers

If you do not follow the IVDR Compliance you cannot sell your products in the EU market. This market is one of the biggest in the world. The regulation helps keep patients from faulty or misleading diagnostic devices.

Here’s why following the IVDR is important:

Market Access: You need to comply with the IVDR to sell products in the EU.

Risk Mitigation: Following the IVDR helps prevent fines, costly. Damage to your brand.

Credibility & Trust: It makes doctors and patients trust your product more.

Global Alignment: The In Vitro Diagnostic Regulation is similar to regulations in countries making it easier to sell products elsewhere.

In short, following the IVDR is not a legal requirement. It’s necessary to compete. The IVDR compliance is crucial, for IVD manufacturers.

3. Major Changes: IVDD vs IVDR

The IVDR has a more organized regulatory framework, than the old in vitro diagnostic directive. Some key changes include: 

These changes are part of a larger movement for management, evidence based IVD review and transparency. 

4. What Devices Fall Under IVDR Regulation? 

The IVDR Regulation covers all products used to examine specimens from the human body for medical purposes. Devices under its scope include:

• Detailed In Vitro Diagnostics: Blood glucose meters, pregnancy tests, lab reagents

• Self Testing Devices: HIV and COVID-19 test kits

• Companion Diagnostics: This Test is used to determine treatment eligibility 

• Genetic Tests and Screening Tools

• Software: Applicable when it controls, supports, or impacts the functionality or interpretation of an IVD.

Manufacturers should evaluate both the intended use and risk level to establish grouping under the IVDR, as its scope is broader and more detailed than that of the In Vitro Diagnostic Device Directive regulation.

5. Summary of Key Changes to In Vitro Diagnostic Regulations

There are some rules for In Vitro Diagnostic Regulations. These rules give people time and make things clearer so they can keep selling In Vitro Diagnostic devices in the European Union market. The new rules are meant to help people understand what they need to do to keep selling In Vitro devices in the European Union market.

6. Classification of IVDs Under IVDR

Under IVDR in vitro devices are divided into four risk groups.These groups are:

Class A: Devices with risk such as laboratory equipment and sample containers.

Class B: Devices with risk for example pregnancy tests and CRP tests.

Class C has devices that're really risky, like tests for infectious diseases such as Hepatitis B.

Class D has the highest risk devices, for example tests for HIV or blood groups that are used when people get blood transfusions.

The way these devices are classified depends on what they're supposed to be used for, how they can affect the health of patients or the public and how important the information they provide is.This system is the same as what's used all around the world and it makes sure that devices are checked carefully based on how risky they are, so devices like tests for Hepatitis B and HIV are checked really carefully. 

7. Role and Importance of Notified Bodies

Under the IVDR framework, Notified Bodies play a completely expanded and critical role in the conformity assessment of In Vitro Diagnostic devices. This is a major shift from the IVDD regulation (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 exceptions  for Class A non-sterile devices.

Regulatory Basis

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

The makers of Class A devices which're not for studying performance have to say that their products agree with the rules by making the EU declaration of conformity mentioned in Article 17. They do this after preparing the documents described in Annexes II and III.

8. Roadmap to IVDR Compliance

Achieving IVDR compliance is a process. It needs planning. You also need to upgrade your quality system and do lots of documentation. Here is a simple plan to help:

1. Do a Gap Assessment: Look at your systems, technical files, quality management system and what you claim about your products. Compare them with IVDR requirements. This step helps find gaps in areas, like Technical Documentation, Post Market Surveillance, Classification and conformity assessment. It does not refer to an Annex but helps identify gaps related to Annex II Annex III, Annex VIII and conformity assessment Annexes IX, X XI.
   
   

2. 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 In Vitro Diagnostic Device Directive regulation.

• Annex VIII – Details classification rules.

• Article 47 – Introduces the risk based classification approach.

Classes B–D require a Notified Body; only Class A non-sterile can self-declare. 

3. Update the technical documentation: The technical file has to be updated to reflect the new requirements and structure.

• Annex II – Describes the required contents of technical documentation.

• Annex III – Adds PMS documentation requirements (e.g., PMS Plan, PMS Report, PSUR).

Check your documentation clearly displays safety, performance, and benefit-risk balance. 

4. Strengthen the Quality Management System : Verify that your Quality Management System meets ISO 13485:2016 standards. It should also include duties, for IVDR.

• 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.

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

• Article 48 – Layouts when NB involvement is required.

• Annex IX / X / XI – Different routes for observance assessment, depending on the classification and documentation strategy.

Early engagement is critical due to limited NB capacity.

6. Obtain Data for Performance Evaluation: Three pillars must be covered by an evidence-based performance evaluation:

• Scientific Validity Report

• Analytical Performance Specifications

• Clinical Performance

• Annex XIII – Sets out requirements for performance evaluation and the Performance Evaluation Report (PER).

This is a core evidence requirement under IVDR.

7. 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.

8. 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 Licensed  Representative
Article 13 – Importer commitments 

You must verify full monitorability and compliance through your supply chain.

9. UDI and labelling Compliance: We need to follow the rules for UDI and labelling. To do this make sure your device labels and packaging are updated to meet the GSPR and UDI requirements. 

• Annex I, Section 20 – Covers general label and information requirement.

• Annex VI – Defines the structure and application of UDI (Unique Device Identifier).

UDI confirms traceability and must be registered in EUDAMED.

10. .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.

While some class A contaminated devices can be self-certified, others require a thorough NB evaluation. 

11. 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 Report: The link between the analyte and the clinical condition (e.g., gene mutation and disease risk).

• Analytical Performance specifications: This is about how well the test can find or measure the thing it is supposed to which is the analyte. 

• Clinical Performance: How well the test performs in real-world clinical settings, including sensitivity, specificity, and clinical utility.

Manufacturers are required to prepare a Performance Evaluation Report , backed by continuous data gathered through Post Market Performance Follow-up activities.

12. Technical Documentation Under In Vitro Diagnostic Regulation

Under IVDR the technical documentation has to be more detailed and structured compared to the directive. This documentation must follow a format. The format is outlined in Annex II. Annex III of the EU regulation (2017/746).

The key elements are:

• 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  observance  and certificates

For the Notified Body and Competent Authorities to review, this document must be up to date and readily available. Obtaining permissions on schedule requires a clear structure and comprehensive information. It is necessary to maintain current documents. Proper structure and completeness are critical for approvals, from the Notified Body and Competent Authorities. 

13. Post Market Surveillance and Vigilance Obligations

Every device must have an active, risk-based PMS system set up by producers in accordance with the IVDR. This system must be built to track actual performance, identify risks early, and take precautions as is required. 

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 and Field Safety Notices

These processes ensure continuous IVDR compliance and patient safety across the entire device lifecycle.

14. IVDR Timelines & Deadlines

The new rules for devices called In Vitro Diagnostic Devices became official on May 26 2022. However some companies that make these In Vitro Diagnostic Devices are still allowed some time to get everything in order. This extra time depends on what kind of In Vitro Diagnostic Device Directive they make. If they have the right certification papers, from the In Vitro Diagnostic Device Directive regulation.

Key dates to know:

15. Language & Labelling Requirements under IVDR

Labelling (Chapter III, Section 20.2) and language requirements (Article 37) are more strict 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 Monitoring.

• Date of manufacture or expiry date where applicable.

• Special storage or handling conditions if required. 

• Sterile indicator and method of sanitation if applicable. 

• Warnings 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 IFU, labels, and safety information must be provided in the official languages 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 and easily understood by the intended user, whether a layperson or healthcare professional.

16. EUDAMED Requirements

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. EUDAMED is the primary platform that includes manufacturers, Authorized Representatives, importers, distributors, Notified Bodies and Competent Authorities. They all register, exchange and monitor information. This is all, under the IVDR regulation. EUDAMED helps them do this. 

Core Requirements in In Vitro Diagnostic Regulation (IVDR)

EUDAMED's requirements are primarily overview in Articles 25 to 34 of the IVDR - Regulation EU (2017/746) and associated Annexes. The main requirements are: 

Actor Registration

• EUDAMED registration is required for importers, manufacturers, and authorized representatives. 

• Each actor receives a Single Registration Number for unique identification.

• Reference: Article 28.

UDI Database

• The Unique Device Identification details have to be uploaded to EUDAMED. 

• Manufacturers need to register the Unique Device Identification Device Identifier and the information about the device. They have to do this for the Unique Device Identification. 

• Reference: Articles 24, to 27 Annex VI. 

Device Registration

• Certificates that are issued by Notified Bodies have to be uploaded to EUDAMED. 

• Device identification, risk class, intended use, manufacturer information, and certifications are examples of information. 

• Reference: Article 26.

Certificates and Notified Body Information

• Certificates that are issued by Notified Bodies have to 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 & Vigilance

• Manufacturers are required to submit trend reports, PSUR, field safety corrective actions and major events to EUDAMED.

• The Commission and competent authorities utilize this information for safety analysis and monitoring. 

• Reference: Articles 82 to 87.

Market Surveillance by Authorities

• Competent Authorities record their market surveillance activities like inspections, audits, enforcement actions in EUDAMED.

• Reference: Article 93 to 100.

Reference

1. IVDR Dates of Application

2. MDCG 2020-16 rev.4 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

3. REGULATION (EU) 2017/746

4. EUDAMED