IVDR Compliance: What Manufacturers Need to Know

A mid-sized U.S. diagnostics manufacturer sells a Class C companion-diagnostic assay into the EU under CE marking earned years ago through IVDD self-certification. If that manufacturer missed the 26 May 2026 deadline for the notified body application for Class C devices, it lost the legacy-device extension. Without a certified pathway in place, the device could no longer be placed on the EU market after 31 December 2028. Since IVDR notified body review commonly runs 12+ months given the current backlog, waiting until the deadline arrives means it’s already too late to start.

Under the old directive, product lists let IVD manufacturers self-certify devices outside higher-scrutiny categories. The IVDR changes that model by requiring notified body involvement for Class B, Class C, Class D, and sterile Class A devices.

This guide covers device classification, compliance requirements, notified body review, and the transition deadlines still ahead.

What Is IVDR?

The IVDR is Regulation (EU) 2017/746, adopted on 5 April 2017, which repeals Directive 98/79/EC, the In Vitro Diagnostic Directive (IVDD). It became applicable on 26 May 2022 and covers IVD medical devices for human use and their accessories, exempting a limited number of devices manufactured and used inside the same healthcare institution.

IVDR vs. IVDD: What Changed

The IVDR replaced IVDD self-certification with a rule-based, risk-tiered system: tighter clinical evidence requirements, required post-market surveillance (PMS), mandatory Unique Device Identification (UDI), European database on medical devices (EUDAMED) registration, a Person Responsible for Regulatory Compliance (PRRC), and broader scope for software and genetic tests. The IVDR and the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) form the EU regulatory framework, jointly overseen by the Medical Device Coordination Group (MDCG). The MDR covers medical devices, and the IVDR covers IVD medical devices and accessories.

Who Needs to Comply With IVDR

IVDR obligations apply across the supply chain, and every operator must show its role supports placing only compliant devices on the market. Manufacturers, Importers, and Distributors Covered by the Regulation need to comply.

Manufacturers carry the heaviest obligations: a quality management system (QMS), a risk management system, a PMS system, a UDI system, EUDAMED registration, and a designated PRRC. Non-EU manufacturers must appoint an EU-established authorized representative before market placement, while importers and distributors verify the Conformité Européenne (CE) marking, the EU Declaration of Conformity, the UDI assignment, and the manufacturer information.

What Counts as an In Vitro Diagnostic Medical Device

The IVDR defines an IVD as any reagent, calibrator, control material, kit, instrument, software, or system intended for the in vitro examination of human specimens. Software falls within scope when its intended purpose is to provide information based on results from other IVDs, even without analyzing specimens itself. Geographically, the IVDR applies across the EU and European Economic Area (EEA) states. Switzerland is a European Free Trade Association (EFTA) member but not an EEA member, so Swiss manufacturers need an EU-authorized representative. Great Britain sits outside IVDR scope post-Brexit, while IVDR continues to apply to Northern Ireland under the Windsor Framework.

The regulation has no domestic effect in the United States, where IVDs remain under Food and Drug Administration (FDA) oversight. Its reach extends to U.S. manufacturers only through export. A U.S.-based company placing a device on the EU market must meet the same obligations as an EU manufacturer, including an EU-authorized representative and notified body review where the device class requires it.

IVDR Device Classification System

Classification sets the compliance route, review depth, and transition deadline. Settle it early, since later changes can reset evidence and notified body planning.

Class A, B, C, and D Risk Categories Explained

The IVDR assigns every IVD to one of four risk classes based on its intended purpose and risk. Class A covers low-risk items such as specimen receptacles; Class B covers moderate-risk devices such as pregnancy tests and is the fallback class; Class C covers high individual and moderate public health risk, and Class D covers the highest risk on both.

How to Determine Your Device’s Classification

Manufacturers apply the classification rules and use the higher class when multiple intended purposes or rules apply. Unclassified devices fall under Class B by default; software has a dedicated decision tree in the EU guidance; and Commission implementing acts can resolve disputes.

Classification’s Impact on Conformity Assessment Requirements

Classification determines whether a notified body reviews the device and to what depth. Manufacturers self-certify non-sterile Class A devices with technical documentation and an EU Declaration of Conformity, while sterile Class A, Class B, Class C, and Class D devices require notified body assessment; Class D devices receive the highest level of scrutiny and may also require EU Reference Laboratory batch testing and expert panel review.

IVDR Compliance Requirements

Manufacturers must keep technical documentation, QMS processes, UDI records, and performance evidence aligned across the device lifecycle.

Technical Documentation Requirements by Device Class

Manufacturers must maintain technical documentation for every class. The core file sits alongside PMS documentation and connects intended purpose, risk controls, performance claims, and post-market evidence. Class D receives the deepest scrutiny through expert panel consultation and per-batch verification testing.

Quality Management System (QMS) Implementation

Every manufacturer, including Class A, must run an effective QMS to obtain CE marking. The International Organization for Standardization (ISO) 13485:2016, which covers medical device quality management systems, is typically the basis for an IVDR-compliant QMS, though it is not legally mandated.

Unique Device Identification (UDI) and EUDAMED Registration

All manufacturers, including Class A, must establish a UDI system. Four EUDAMED modules became mandatory on 28 May 2026 under Commission Decision (EU) 2025/2371, though Vigilance remains optional.

Clinical Evidence and Performance Evaluation Standards

Manufacturers continuously document performance evaluations in the Performance Evaluation Report (PER). Scientific validity links the analyte to a clinical or physiological state. Analytical performance shows reliable detection or measurement, and clinical performance shows that results correlate with the target condition in the intended population.

Supply Chain and Economic Operator Obligations

Manufacturers and authorized representatives need at least one PRRC, responsible for vigilance, PMS, and QMS fulfillment before device release. A single entity may hold both the authorized representative and importer roles if it meets the requirements for each role independently.

The Role of Notified Bodies in IVDR Certification

Notified bodies gatekeep every IVDR class above non-sterile Class A, and their capacity should shape the compliance plan before submission work begins.

The Conformity Assessment and Certification Process

A notified body must independently assess conformity for every class above non-sterile Class A; Class D also requires an EU Reference Laboratory assessment. The process starts with an application review and continues through the QMS audit and technical documentation assessment before the certificate is released. Reviewer questions, remediation, translations, and consultations with a competent authority or the European Medicines Agency (EMA) can extend timelines.

Selecting and Working With a Notified Body

Choosing a notified body starts with matching its designation scope to your device type and class. Some bodies exclude Class D, and a withdrawn application can become visible to others via EUDAMED. Before committing, check the points below:

Designation scope, capacity, and timing: Confirm the body covers the device class and can absorb the workload, since capacity is scarce. High-risk devices often face long timelines, so contact a body well ahead of your deadline.

Geographic and language fit: If documentation is not in the body’s requested language, you must supply translations or supplementary summary reports.

Lock these choices before committing to a submission timeline.

Post-Market Surveillance and Vigilance Under IVDR

After certification, manufacturers must maintain class-appropriate PMS, Periodic Safety Update Reports (PSURs), vigilance reporting, and corrective actions as routine evidence streams.

Post-Market Surveillance Plan Requirements

Manufacturers must actively gather and analyze safety and performance data throughout a device’s entire life cycle. The PMS system must match risk class and device type, integrate with the QMS, and connect to corrective actions.

Periodic Safety Update Reports (PSURs)

Reporting cadence follows device class. Class A and B manufacturers maintain a Post-Market Surveillance Report, updated as needed, while Class C and D manufacturers produce PSURs regularly, with Class D reports going to the notified body via EUDAMED.

Incident Reporting and Corrective Action Obligations

Serious incident reporting deadlines depend on severity, with the shortest timelines for serious public health threats. Manufacturers must file when uncertain whether an incident is reportable and normally do so before taking Field Safety Corrective Action, except in emergencies.

IVDR Compliance Timeline and Transition Deadlines

Manufacturers need to plan for final transition dates, interim application, and written agreement milestones.

Milestones Since IVDR’s Entry Into Force

The current transition deadlines are class-stratified under Regulation (EU) 2024/1860. The regulation entered into force on 25 May 2017, applied from 26 May 2022, and was later amended by Regulations (EU) 2022/112, 2023/607, and 2024/1860.

Extended Transition Periods by Device Class

Extended transition periods apply to qualifying legacy IVDs covered by an IVDD certificate or declaration of conformity issued before 26 May 2022. These devices may continue to be placed on the market or put into service through the applicable transition date, provided they continue to comply with the IVDD, have no significant changes in design or intended purpose, present no unacceptable risk, and meet the applicable IVDR QMS, notified body application, and written agreement requirements. The table below pairs each application deadline with its final transition date.

Device Category	Notified Body Application Deadline	End of Transition
Class D self-declared / IVDD-certified	26 May 2025 (passed)	31 December 2027
Class C self-declared	26 May 2026 (passed)	31 December 2028
Class B self-declared	26 May 2027	31 December 2029
Class A sterile self-declared	26 May 2027	31 December 2029

Deadlines Manufacturers Still Need to Plan Around

The written agreement deadline for Class C devices falls on 26 September 2026. Class B and Class A sterile manufacturers face a 26 September 2027 deadline, and missing either milestone ends the transition at that date.

Common IVDR Compliance Challenges for Manufacturers

Manufacturers must secure notified body capacity and remediate IVDD-era files while maintaining traceable evidence.

Notified Body Capacity Constraints

Applications continue to outpace certificates, with IVDR certification concentrated among a small pool of designated bodies across a subset of member states. This capacity ceiling makes early application central to planning.

Gaps Between IVDD and IVDR Documentation Practices

Submissions often require significant remediation before review can proceed. Performance evaluation creates the sharpest gap, since the PER integrates scientific validity, analytical performance, and clinical performance reports that IVDD practice didn’t require in the same way.

Managing Traceability Across Complex Supply Chains

Technical documentation runs deeper than under the IVDD. A single file now spans device description, risk management under ISO 14971, analytical and clinical performance data, stability studies, PMS and post-market performance follow-up (PMPF) plans, UDI records, cybersecurity documentation, and software lifecycle evidence under International Electrotechnical Commission (IEC) 62304.

Building an IVDR Compliance Strategy

Manufacturers should sequence compliance work by classification, deadline, and evidence risk.

Conducting a Gap Analysis Against Current Processes

An initial gap analysis assesses whether the device’s classification changes under the IVDR and whether the current QMS and documentation meet expectations. The PER review should compare current evidence against IVDR requirements and identify data gaps, then cover these areas:

Classification and traceability: Confirm the rule, intended purpose, rationale, and links among requirements, risk controls, verification, and PMS/PMPF evidence.

Performance evidence: Check scientific validity, analytical performance, clinical performance, and current evidence.

Sequence remediation against these gaps before submission work begins.

Prioritizing Documentation and QMS Updates

Manufacturers should prioritize by the transition deadline for the device class. Analytical performance data draws particular scrutiny, including sensitivity, specificity, precision, and interference from substances, while software-containing devices require IEC 62304 lifecycle documentation and validation across hardware configurations and operating systems.

Establishing Ongoing Compliance Monitoring

PMS runs continuously, the PER updates regularly, and the notified body reviews it at PSUR or substantial-change reviews. Unannounced audit visits verify that day-to-day practice matches the approved documentation, and any doubt about a substantial change should be referred to the notified body.

How Jama Connect Supports IVDR Compliance

The IVDR’s lifecycle model requires technical documentation, risk management, performance evaluation, and PMS to remain linked and up to date. Jama Connect® centralizes requirements, risk, testing, reviews, and compliance documentation, while its requirements management capabilities and end-to-end traceability support regulated product teams as designs evolve.

It includes a pre-built medical device framework aligned to design controls with Live Traceability™ that keeps links current. When a requirement changes, suspect links alert downstream owners to review the connected evidence, while audit trails and electronic signatures support compliance with Title 21 of the Code of Federal Regulations (CFR) Part 11.

Prepare IVDR Evidence Before Deadlines Force Action

Manufacturers that avoid IVDR market-access disruption treat readiness as an ongoing program, active before and after certification.

If your team isn’t sure IVDR evidence in disconnected documents can withstand an auditor’s questions, Jama Connect keeps requirements, risk, and verification evidence linked so that the connection holds up under review. You can start a free 30-day trial to test it against your own traceability.

Frequently Asked Questions About IVDR Compliance

What should manufacturers check first for IVDR compliance?

Classification comes first, followed by requirements management best practices that documents the rule, intended purpose, rationale, and any borderline assumptions in the technical file. If software, companion diagnostic status, or multiple intended purposes could shift the class, flag that early so QMS, PER, PMS, UDI, and notified body planning don’t proceed from an unstable premise.

Does IVDR apply to software used in diagnostics?

Yes, when the software’s intended purpose is to provide diagnostic information based on in vitro examination of human specimens or results from other IVDs. The intended purpose statement is the control point, and the decision tree, verification, validation, and lifecycle records support classification.

How long is the IVDR transition period for legacy devices?

It depends on the class and remains available only if legacy-device conditions and interim milestones are met. A deadline register should pair the final transition date with the application and written agreement dates, with owners assigned before each.

What happens if a manufacturer misses an IVDR deadline?

Missing an applicable notified body application or written agreement deadline can cause a legacy device to lose eligibility for the extended transition period. Unless another compliant pathway is available, the manufacturer would no longer be able to continue placing that device on the EU market under the IVDD transition provisions.

This article was authored by Tom Rish and published on August 20, 2026.