EU IVDR: Definition, Requirements, and Compliance

The European Union In Vitro Diagnostic Medical Devices Regulation (EU IVDR), also known as Regulation (EU) 2017/746, provides a harmonized legal framework for the regulation of in vitro diagnostic (IVD) medical devices across the EU and EEA.

EU IVDR replaces the earlier IVDD (98/79/EC) directive, introducing more robust requirements to enhance patient safety, improve transparency, and strengthen traceability. Key regulatory changes include stricter demands for clinical evidence, implementation of a standardized Unique Device Identification (UDI) system, and broader involvement of Notified Bodies in conformity assessments.

EU IVDR was adopted in May 2017 and initially set for complete implementation on May 26th, 2022. However, due to COVID-19-related disruptions and industry readiness challenges, the transition was staggered by device risk classification. For example, Class D devices must comply by May 2025, Class C by May 2026, and Class B and sterile Class A by May 2027. Legacy devices or those placed on the market under IVDD may remain available if they meet specific transitional requirements and post-market obligations.

Under IVDR, IVD devices are categorized into four risk-based classes: A, B, C, and D. The classification is based on the IVD device’s potential impact on individual patients and public health. While Class A non-sterile devices may be self-certified, all higher-risk classes require Notified Body certification before market entry.

The EU IVDR encompasses detailed requirements for performance evaluation, classification, and conformity assessment. Other requirements include clinical evidence, post-market surveillance (PMS), and regulatory collaboration.

Key regulatory changes to IVDR compared to IVDD include a broader scope covering companion diagnostics and software, 80–90% notified body oversight, mandatory clinical evaluations, and integration into the EUDAMED database.

Compliance with EU IVDR requires device classification, a quality management system, clinical data, technical documentation, EUDAMED registration, and Notified Body involvement, where required. All economic operators, such as manufacturers, authorized representatives, importers, and distributors, must fulfill specific regulatory roles and responsibilities.

Medical device companies may use an electronic Quality Management System (eQMS) to manage EU IVDR compliance. Electronic QMS centralizes documentation, automates workflows, manages risk, and helps track surveillance.

SimplerQMS is a fully validated QMS software that helps ensure audit readiness through robust data control and comprehensive coverage of all quality management processes across the medical device lifecycle.

What Is EU IVDR?

The European Union In Vitro Diagnostic Medical Devices Regulation (EU IVDR), also known as Regulation (EU) 2017/746, sets the legal framework for placing in vitro diagnostic medical devices on the EU market. EU IVDR is also commonly referred to as EU IVDR 2017/746 or simply Regulation (EU) 2017/746.

EU IVDR aims to ensure the safety, performance, and reliability of in vitro diagnostic medical devices across the European Union.

EU IVDR replaces the earlier In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC, which had been in effect since 1998. EU IVDR, being a regulation, applies uniformly across all EU member states without needing national laws. In contrast, the IVDD, as a directive, allowed member states to transpose it into national laws with variations.

The EU replaced IVDD with IVDR to address rapid technological advancements in diagnostic testing, enforce stronger safety oversight, and ensure traceability and transparency.

The European Parliament adopted IVDR on 5 April 2017. IVDR became applicable on May 26, 2022, postponed from 2021 due to COVID-19. Transition deadlines vary by device class.

What Is the Applicability of the EU IVDR?

EU IVDR applies to IVD medical devices and their accessories intended for human use within the EU and the European Economic Area (EEA), including Iceland, Liechtenstein, and Norway.

The scope includes any medical device that is a reagent, calibrator, control material, kit, instrument, software or system to be used alone or in combination for the in vitro examination of specimens, including blood and tissue. Specimen receptacles are also considered IVDs. IVD devices are used to diagnose, monitor, or screen for particular diseases, conditions, or infections. They are also used to perform genetic testing and to determine treatment compatibility.

Beyond devices themselves, EU IVDR extends the regulation to all economic operators involved in the device lifecycle, outlining obligations for manufacturers, authorized representatives for non-EU entities, importers, and distributors.

According to Article 1(3), EU IVDR excludes the following.

• General laboratory products or research-use-only products, unless specifically intended to be used for in vitro diagnostic examination.
• Invasive sampling devices or products are applied directly to the human body for sample collection.
• Internationally certified reference materials.
• External quality assessment materials.

Health institutions may be exempt from certain IVDR obligations when manufacturing and using IVDs in-house, provided they meet strict EU IVDR Article 5(5) conditions. These conditions include implementing a quality management system, maintaining appropriate documentation, and demonstrating that specific patient needs cannot be met by commercially available devices.

What Is the Importance of EU IVDR?

EU IVDR is important as it establishes stricter requirements for the safety, performance, and traceability of IVD medical devices marketed in the EU and the EEA. By setting higher regulatory standards, EU IVDR ensures a consistent and elevated level of protection for patients and users across all member states.

EU IVDR’s impact extends beyond European borders. EU IVDR affects non-EU companies that intend to access the EU market, positioning IVDR compliance as a de facto global benchmark. Its rigorous framework influences other international regulatory regimes, fostering a globally harmonized approach to IVD device oversight and increasing global confidence in certified products.

Several key motivations behind the overhaul of EU IVDR are listed below.

• Patient Health and Safety: IVDR enforces clinical evidence, risk-based classification, and performance evaluation to ensure the safety and efficacy of devices released to market, reducing patient risk.
• Transparency and Traceability: Unique Device Identification (UDI) and EUDAMED registration improve traceability, streamline recalls, and deter counterfeit products.
• Post-Market Surveillance: Proactive monitoring, post-market performance follow-up (PMPF), and vigilance reporting shift oversight from reactive to preventive.
• Increased Oversight of Notified Bodies: IVDR mandates Notified Body oversight for the majority of medical devices, thus improving external review,  accountability, and patient safety.

What Are the EU IVDR Implementation Timeline and Transitional Provisions?

EU IVDR was adopted in May 2017 and initially set for complete implementation on May 26th, 2022. However, due to industry readiness challenges and COVID-19 disruptions, its implementation was staggered with extended transition deadlines based on device classification.

The timeline table and transitional provisions are based on the amendments introduced by Regulation (EU) 2022/112, which modified Article 110 of Regulation (EU) 2017/746 (EU IVDR).

The table below shows the original timeline vs. the updated deadlines based on Regulation (EU) 2022/112.

Device Type	Original Deadline	Updated Deadline (Current)
All IVDs	26 May 2022	Class-dependent extensions
Class D (highest risk)	26 May 2022	Until 26 May 2025
Class C	26 May 2022	Until 26 May 2026
Class B and Class A sterile	26 May 2022	Until 26 May 2027

CE certification confirms that a device meets EU requirements and can be legally marketed in the EEA. Legacy devices or IVDs that were certified or self-declared under IVDD before May 26, 2022, may remain on the market if no significant changes to the design or intended use have occurred.

The extended validity of CE certification applies only to devices lawfully marketed under the IVDD that have not undergone significant changes. Additionally, manufacturers must also implement an IVDR-compliant quality management system (QMS), and fulfill all applicable post-market requirements.

While EU IVDR implementation is necessary, the Notified Body’s capacity remains limited, posing a risk and a challenge to timely certification within the extended transition periods.

What Is the EU IVDR Classification System?

According to Annex VIII of EU IVDR, the EU IVDR classification system assigns IVD medical devices to four risk-based classes, Class A, B, C, and D. The classification system is based on their intended use and associated risks to individuals and public health.

The EU IVDR medical device classification system overview is outlined below.

• Class A: Has low patient risk and low public health risks. They include laboratory instruments, buffer solutions, and specimen receptacles.
• Class B: Has moderate patient risk and low public health risk. They include pregnancy tests, cholesterol tests, and urine glucose tests.
• Class C: Has high patient risk and moderate public health risk. They include sexually transmitted infection tests, cancer markers, and human genetic tests.
• Class D: Has both high patient risk and high public health risk. They include tests for life-threatening transmissible diseases and blood screening for transfusion.

Under the IVDR, only class A non-sterile devices can be self-certified by the manufacturer.

IVD devices from the remaining classes must be audited and certified by a Notified Body before marketing.

What Is the EU IVDR Regulation Structure?

The EU IVDR is 157 pages long and structured into 10 Chapters, 113 Articles, and 15 Annexes to comprehensively cover all legal, technical, and procedural requirements for in vitro diagnostic devices.

The breakdown of the EU IVDR structure is outlined below.

• 10 Chapters: Each chapter outlines major regulatory themes, including scope, safety, performance requirements, conformity assessment procedures, Notified Bodies, market surveillance, and more.
• 113 Articles: The articles outline enforceable regulatory requirements, guiding manufacturer obligations, registration of economic operators and devices, QMS, performance evaluation and clinical evidence, and market oversight.
• 15 Annexes: The annexes detail compliance frameworks, including General Safety and Performance Requirements (GSPR), technical documentation, post-market surveillance, notified body requirements, classification rules, and conformity assessment procedures.

An overview of the 10 chapters of EU IVDR is provided below.

Chapter	Title	Focus
I	Introductory Provisions	Establishes the regulation’s scope, definitions, and regulatory status of products and counseling.
II	Making Available on the Market and Putting Into Service of Devices, Obligations of Economic Operators, CE Marking, Free Movement	Requirements for placing devices on the market and obligations of economic operators and PRRC.
III	Identification and Traceability of Devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices	UDI (Unique Device Identification) system, device registration, EUDAMED database.
IV	Notified Bodies	Defines the designation, responsibilities, and oversight of Notified Bodies involved in the conformity assessment of IVDs.
V	Classification and Conformity Assessment	Outlines the risk-based classification system (Classes A–D) and the procedures manufacturers must follow to demonstrate regulatory compliance.
VI	Clinical Evidence, Performance Evaluation, and Performance Studies	Mandates requirements for clinical evidence generation, performance evaluation (including scientific validity, analytical and clinical performance), and performance studies.
VII	Post-Market Surveillance, Vigilance and Market Surveillance	Describes obligations for ongoing monitoring of devices after market release, including incident reporting, FSCA, and coordinated market oversight.
VIII	Cooperation Between Member States, Medical Device Coordination Group, EU Reference Laboratories, and Device Registers	Promotes regulatory harmonization through coordinated activities, expert panels, and shared infrastructure across EU Member States, outlines requirements of EU Reference Lab.
IX	Confidentiality, Data Protection, Funding, and Penalties	Covers legal aspects of data confidentiality, protection of personal information, financial provisions, and enforcement mechanisms.
X	Final Provisions	Specifies transitional arrangements, repeal of previous directives, and legal mechanisms for implementation and amendment of the regulation.

What Are the Key Changes Introduced by EU IVDR Compared to EU IVDD?

The key changes introduced by EU IVDR compared to EU IVDD are listed below.

• Risk-Based Classification System: The IVDR introduces a modernized, risk-based classification framework, Classes A, B, C, and D. This replaces the outdated IVDD list-based system.
• Notified Body Oversight: Under IVDR, 80–90% of IVDs now require Notified Body assessment, which is a significant increase compared to ~15% under the IVDD.
• Stricter Clinical Evidence Requirements: The IVDR mandates rigorous performance evaluation documentation, incorporating scientific validity, analytical performance, and clinical performance. These requirements were less clearly defined under IVDD.
• Post-Market Surveillance (PMS) and Vigilance: Under IVDR, manufacturers must implement robust PMS systems, including Post-Market Performance Follow-Up (PMPF) and detailed vigilance reporting.
• Unique Device Identification (UDI) System and EUDAMED: A UDI system is now compulsory under IVDR for traceability. Device data registration in the centralized EUDAMED database enhances transparency.
• Increased Transparency: The IVDR requires public access to Safety and Performance Summaries (SSPs) for Class C and D devices, ensuring the availability of key performance evidence.
• Stricter Control of In-House Devices: IVDR Article 5(5) introduces new conditions for health institutions using in-house-manufactured IVDs, tightening a previously lenient scope under IVDD.
• Expanded Scope and Definitions: IVDR explicitly covers companion diagnostics, genetic testing, and medical software, substantially expanding the scope from IVDD, which lacked such precise inclusions.
• Harmonized Requirements Across the EU: Unlike the IVDD directive, which required national transposition, IVDR is a regulation that directly applies across all EU and EEA states, ensuring legal consistency.

How to Ensure EU IVDR Compliance?

To ensure EU IVDR compliance, economic operators must fulfill all legal, safety, performance, documentation, and post-market obligations outlined in Regulation (EU) 2017/746 or EU IVDR. Since responsibilities vary across economic operators, the specific steps to ensure compliance will differ depending on the role. Meeting these requirements is essential to lawfully affix the CE marking and place IVD medical devices on the EU market.

The steps to ensure EU IVDR compliance for manufacturers, according to euivdr.com, are listed below.

1. Define Intended Use and Classify the Device: State the intended medical purpose of the IVD. Use Annex VIII to assign the appropriate risk class (A, B, C, or D) based on risk to patient and public health.​
2. Establish Required Processes and Resources: Implement a compliant QMS. For example, allocate trained personnel, appoint an authorized representative (if not based in the EU), define roles, and set up systems for documentation, traceability, and risk control.​
3. Minimize Risk and Fulfill General Safety and Performance Requirements (GSPR): Apply the risk management principles listed in Annex I, Chapter I to design, manufacture, storage, and labeling. Ensure safety and minimize known and foreseeable risks.​
4. Complete the Performance Evaluation: Generate scientific validity, analytical performance, and clinical performance data to support the intended use of the IVD device. Follow the performance evaluation plan and update with PMPF as needed.​
5. Compile Technical Documentation: Prepare comprehensive documentation per Annexes II and III, including device description, intended purpose, performance data, labeling, UDI information, and risk management file.​
6. Make Arrangements for Distribution: Verify that packaging, storage, and shipping meet IVDR requirements. Establish agreements with importers and distributors to ensure they understand and fulfill their responsibilities.​
7. Register Device and Manufacturer: Assign Basic UDI-DI, register the device, and enter economic operator details into EUDAMED. Keep records updated and accessible to authorities.​
8. Complete Conformity Assessment: For Class A (sterile), B, C, or D devices, engage a Notified Body for the appropriate conformity assessment route (see Annexes IX, X, or XI). Obtain the IVDR certificate as applicable.​
9. Complete Final Administrative Procedures: Affix the CE marking, ensure the Notified Body number is included if required, and finalize labeling and instructions for use.​
10. Fulfill Post-Market Obligations: Implement ongoing PMS and vigilance systems. Monitor real-world performance, report incidents, and continuously update technical documentation and performance evaluation based on new data or risk information.​

The authorized representative (AR) should consider the following steps below to ensure EU IVDR compliance.

1. Establish a Written Mandate with Manufacturer: Set up a formal, signed agreement that defines the scope of tasks delegated by the manufacturer. The mandate must specify which obligations under IVDR the authorized representative will carry out.
2. Verify Compliance Documentation: Ensure the manufacturer has drawn up the EU Declaration of Conformity and the required technical documentation. Confirm that the applicable conformity assessment procedure has been performed.
3. Maintain Technical Documentation Access: Keep updated copies of technical documentation, EU declarations, CE certificates, and amendments. Make these documents available to competent authorities upon request.
4. Confirm EUDAMED Registration: Verify that the manufacturer has correctly registered the device, the authorized representative, and other required information in EUDAMED.
5. Communicate with Authorities: Act as the official EU contact point. Cooperate in preventive or corrective actions, and immediately inform the manufacturer of complaints, adverse events, or requests for device samples from authorities.
6. Accept Liability (if required): The authorized representative is jointly liable with the manufacturer for defective devices if the manufacturer is non-compliant and located outside the EU.
7. Monitor Manufacturer’s Compliance: Terminate the mandate if the manufacturer breaches IVDR obligations. Immediately notify the competent authority in the country where the AR is based and the relevant notified body, with reasons.
8. Ensure the Manufacturer Maintains Legal Responsibility for Core Duties: Do not take over core responsibilities of the manufacturer such as device design, QMS, and technical documentation creation. These tasks must remain with the manufacturer.
9. Ensure Access to Person Responsible for Regulatory Compliance (PRRC): Have permanent and continuous access to a PRRC in line.
10. Manage Representative Transitions: Coordinate a clear agreement between the manufacturer, outgoing AR, and new AR to manage responsibility and document transfer, if changing representatives.

The recommended steps for importers to ensure EU IVDR compliance are listed below.

1. Verify CE Marking and Documentation: Confirm that each device carries a valid CE marking and EU Declaration of Conformity (DoC).
2. Confirm UDI Assignment and EUDAMED Registration: Importers must verify that the device has been assigned a valid UDI and is accurately registered in EUDAMED.
3. Ensure Labeling and Instructions for Use (IFU) Compliance: The device labeling and IFU must meet IVDR labeling requirements, including correct language and traceability information.
4. Provide Accurate Importer Identification: Importers must ensure their name, registered trademark, address, and contact details appear on the product packaging or include documentation.
5. Maintain Storage and Transport Conditions: Importers should ensure that storage and transport conditions uphold the device’s regulatory conformity.
6. Withhold and Report Non-Compliant Devices: Devices suspected of being non-compliant must be withheld from the EU market. Inform the manufacturer and AR immediately, and notify the competent authorities if there is a serious risk or falsification.
7. Monitor Complaints and Device Issues: Keep an internal register of complaints, recalls, withdrawals, and non-conforming devices. Share relevant data with the manufacturer and authorized representative as required.
8. Cooperate with Competent Authorities: Be prepared to provide samples, documentation, and full regulatory access to competent authorities upon request. This is essential for inspection readiness and legal compliance.
9. Refer to Official MDCG Guidance Documents: Use detailed MDCG documents such as MDCG 2021-27 Clarifying Articles 13 & 14 for economic operators and MDCG 2021-26: Guidelines for repackaging and relabeling.

An IVD device distributor can consider the following steps below to ensure EU IVDR compliance.

1. Perform Representative Sampling Checks: Perform representative sampling to ensure devices bear the CE marking and have an EU Declaration of Conformity. Check if IVD devices are compliant with labeling and IFU in the languages accepted in the destination Member State.
2. Confirm Traceability Information: Verify that each device or accompanying documentation includes the importer’s name and address (as applicable) and the device’s UDI.
3. Review Storage and Transport Conditions: Ensure that storage and transportation conditions under the distributor’s control align with the manufacturer’s specified requirements.
4. Withhold Non-Compliant Devices: Distributors must withhold from distribution any device suspected to be non-compliant. Notify the manufacturer, importer, and authorized representative promptly, maintaining proactive regulatory accountability under IVDR.
5. Alert Authorities for Serious Risks: The distributor must immediately inform the national competent authority if there is suspicion of device falsification or discovery of a serious health risk.
6. Maintain Complaint and Recall Records: Keep a detailed register of complaints, non-conforming devices, recalls, and withdrawals. Share this data with other economic operators (manufacturers, importers) and competent authorities upon request, ensuring vigilance and transparency under IVDR.
7. Cooperate with Authorities: Provide compliance documentation, access to relevant records, and full support during regulatory inspections or investigations, if requested.
8. Apply Relevant Guidance: Distributors should refer to official MDCG guidance documents, including MDCG 2021-27 Rev.1 Clarifying Articles 13 & 14 for economic operators and MDCG 2021-26 Explaining Article 16 obligations around repackaging and relabeling.

How Does the EU IVDR Differ From ISO 13485?

The main difference between EU IVDR and ISO 13485 lies in their nature and purpose. EU IVDR, as Regulation (EU) 2017/746, is a legally binding framework applicable across all EU and EEA countries. EU IVDR governs the entire lifecycle of IVD medical devices, including requirements for safety, performance, clinical evidence, PMS, technical documentation, and market access. Non-compliance with IVDR can result in serious consequences such as market exclusion, legal sanctions, or product recalls. The regulation mandates strict conformity assessment procedures, classification rules, UDI, and EUDAMED registration.

In contrast, ISO 13485 is an international, voluntary standard that outlines requirements for a QMS specific to medical device manufacturing. While it is not legally binding, regulators and Notified Bodies often expect compliance with ISO 13485, particularly during conformity assessments. ISO 13485 focuses on process control, documented procedures, risk management, and continual improvement. Adherence to ISO 13485 alone does not suffice for market access under EU IVDR.

How Does the EU IVDR Differ From the EU MDR?

The main distinction between EU IVDR and EU MDR is the types of medical devices they regulate. EU IVDR governs IVD medical devices, those used to examine human specimens such as blood or tissue outside the body to generate diagnostic information. EU IVDR employs a risk-based classification system with Classes A, B, C, and D, based on public and patient health risks. Performance evaluation under IVDR focuses on scientific validity, analytical performance, and clinical performance. A unique feature of IVDR is the involvement of EU reference laboratories, particularly for high-risk Class D devices. Post-market oversight centers on PMPF, emphasizing real-world performance data.

In contrast, EU MDR applies to general medical devices used directly on or in the human body for purposes such as diagnosis, prevention, monitoring, or treatment. These medical devices include implants, surgical instruments, and diagnostic imaging tools. EU MDR classifies devices into Classes I, IIa, IIb, and III, primarily based on invasiveness and potential harm. Unlike IVDR, MDR does not incorporate reference laboratories into the certification process. Instead, it requires rigorous clinical investigations and clinical evaluation reports grounded in real-world patient data. PMS focuses on PMCF to monitor ongoing safety and performance from the patient’s perspective.

What is the Role of Medical Device eQMS in Ensuring Compliance With EU IVDR?

A medical device eQMS plays a critical role in ensuring compliance with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) by providing a structured, traceable, and efficient framework for managing quality processes, documentation, and regulatory requirements.

Electronic QMS provides centralized document management, ensuring version control, access restrictions, and full audit trails for documentation. The system also supports automated workflows for CAPA, audits, and change control, promoting timely and traceable quality interventions. Furthermore, it enhances PMS and vigilance by tracking complaints, incidents, and follow-up activities in line with Articles 78 to 87 of the regulation.

The benefits of using a medical device eQMS include the listed below.

• Centralized Document Management and Control: A robust eQMS ensures secure and centralized document management. It provides real-time version control, electronic signatures, and automated access permissions. These capabilities ensure compliance with EU GMP Annex 11 and FDA 21 CFR Part 11.
• Automated Workflows for CAPA, Audits, and Change Control: Built-in automation for processes such as CAPA, internal audits, and change management ensures traceability, workflow standardization, and compliance with Article 10 of EU IVDR.
• Integrated Risk Management and Clinical Evaluation Tracking: eQMS solutions integrate risk management, clinical evaluation, and technical documentation within a unified digital framework to seamlessly align with relevant guidance documents.
• Monitoring of PMS and vigilance reporting: eQMS facilitates PMS, PMPF, and vigilance reporting through templated reports, automated scheduling, and dashboards, enabling timely submission and proactive compliance monitoring.

SimplerQMS offers a fully validated QMS software according to GAMP5 tailored for medical device companies to increase efficiency, reduce errors, and achieve faster audit readiness, and scalability.

Compliant with FDA 21 CFR Part 11 and EU Annex 11, SimplerQMS supports compliance with EU IVDR, EU MDR, FDA 21 CFR 820, and ISO 13485 requirements by covering processes such as document control, CAPA, training, supplier management, and audits. Additionally, SimplerQMS enables economic operators to maintain regulatory compliance and readiness for Notified Body audits.