EU IVDR: what it is, who it applies to, and how CE marking works

What is the EU IVDR?

Regulation (EU) 2017/746 is the European Union's law for placing an in vitro diagnostic medical device on the EU market. It sets the safety and performance requirements a device must meet, the performance evaluation and technical documentation that show it, and the conformity assessment before the CE mark goes on, through a notified body for all but non-sterile Class A.

It has applied since 26 May 2022 and replaced the In Vitro Diagnostic Medical Devices Directive, under which most IVDs were self-declared. Under the IVDR most of them need a notified body. The CE mark signals the manufacturer's own EU declaration of conformity, and the notified body's certificates cover the quality management system and the technical documentation it rests on.

Who does the EU IVDR apply to?

Manufacturers placing an IVD on the EU market, from reagents and analysers to self-tests and diagnostic software, wherever the company is based. A manufacturer outside the EU also appoints an authorised representative in a member state

Manufacturers still selling devices under the IVD Directive, who have until the end of 2027, 2028 or 2029 by class to complete IVDR conformity assessment, provided they met the quality management system, application and written agreement conditions in time

Health institutions and laboratories that make and use their own tests, which the regulation exempts only under the conditions in Article 5(5), including an appropriate quality management system

The regulation becomes urgent when the written agreement deadline for your class gets close, when the notified body's surveillance audit goes on the calendar, or when the person responsible for regulatory compliance asks which performance evaluation report is current and nobody is sure.

What the IVDR asks of a manufacturer

The manufacturer's obligations sit in Article 10 and point at the annexes. Most of them end as a procedure or a record in the quality management system the notified body audits.

Classification (Article 47, Annex VIII)

Class A, B, C or D under seven rules, by the risk a wrong result carries for the patient and for public health, with self-tests and companion diagnostics placed by rules of their own

General safety and performance requirements (Annex I)

Three chapters: general requirements including risk management, requirements on design and manufacture including analytical and clinical performance, and the label and instructions for use

Quality management system (Article 10(8))

Covering regulatory strategy, management responsibility, resources and suppliers, risk management, performance evaluation, product realisation, UDI, post-market surveillance, vigilance and corrective action, and audited by the notified body for every class except non-sterile Class A

Technical documentation (Article 10(4), Annex II and III)

The file the notified body assesses before the CE mark goes on, with the post-market surveillance documentation that keeps it current

Performance evaluation (Article 56, Annex XIII)

Scientific validity, analytical performance and clinical performance, planned, reported and updated through the device's life with post-market performance follow-up

Post-market surveillance (Articles 78 to 81)

A PMS plan for every device, a PMS report for Class A and B and a periodic safety update report for Class C and D

Vigilance (Articles 82 to 84)

Serious incidents and field safety corrective actions reported to the competent authority within the regulation's deadlines

UDI, registration and a person responsible for regulatory compliance (Articles 24 to 28 and Article 15)

A unique device identifier on the device and in EUDAMED, and a named person who checks conformity before release

How CE marking works for an IVD

1. Classify the device under Annex VIII

And choose the conformity assessment route. The class decides whether a notified body is involved and how much of the technical documentation it assesses.

2. Show the general safety and performance requirements are met

Risk management, analytical and clinical performance, design verification and validation and the labelling, each against a requirement in Annex I, with the harmonised standards and any common specifications named.

3. Run the quality management system under Article 10(8)

With the PMS plan, the vigilance procedure and the performance evaluation plan inside it, and compile the technical documentation to Annex II and III from the work it produces.

4. Conformity assessment

For Class B, C and D and sterile Class A the notified body audits the quality management system and assesses the technical documentation, for every Class D device and a sample of the rest. Class D devices also go to an EU reference laboratory where one is designated. Non-sterile Class A manufacturers self-declare.

5. Declare, mark and keep it current

Sign the EU declaration of conformity, affix the CE mark and register the device in EUDAMED, then run the yearly surveillance audits, the PSUR cycle and the performance evaluation updates for as long as the device is on the market.

THE EU IVDR IN QUALIO

Qualio maps your procedures, complaints and performance evaluation records to the IVDR's articles, so the notified body finds each one where the regulation puts it

Qualio breaks the IVDR down article by article and maps your procedures, performance evaluation reports, complaints and CAPAs to the articles they answer. When a record changes, it reassesses the articles it touches and recommends a fix for any gap. Copilot drafts the procedure update or the CAPA from the recommendation, and your team approves it. When the surveillance audit is booked, you export the evidence by article.

The quality management system under Article 10(8) assessed against the IVDR and ISO 13485 in the same library, so each requirement they share is answered once

Complaints and CAPAs for Articles 82 to 84 held with the vigilance decision dated and signed on each complaint, ready for the notified body to sample at surveillance

Performance evaluation and post-market surveillance procedures as controlled documents, with training assigned on the effective date of every revision

The technical documentation under Annex II and III compiled from the requirements, risks, tests and approvals already in Qualio, so the file the notified body assesses and the procedures it audits are read together

Standards that apply alongside the EU IVDR

Medical devicesISO 13485: EN ISO 13485:2016 with amendment A11:2021, the harmonised standard for the quality management system Article 10 asks for
Medical devicesISO 14971: The harmonised risk management standard behind the risk requirements in Annex I and the risk management file the manufacturer keeps for every device
LaboratoriesISO 15189: The standard for medical laboratories, which a health institution making its own tests under Article 5(5) is expected to meet
Medical devicesIEC 62304: The software lifecycle a notified body expects to see for IVDs that are or contain software, from instrument firmware to the software that interprets a result
Medical devicesEU MDR: The sibling regulation for medical devices, Regulation (EU) 2017/745, with the same structure and its own classification rules, clinical evaluation and transition dates

Ender Diagnostics

Ender Diagnostics, a Swiss developer and manufacturer of rapid molecular diagnostic kits, built its in vitro diagnostic quality management system in Qualio.

Read the Ender Diagnostics story

Guides and webinars for the EU IVDR

Webinar

Webinar recording: IVDR compliance: tips and best practice

IVDR timeline: transition ended 26 May 2022 and IVDD certificates became void after 27 May 2025

Blog

Ultimate guide to the EU IVDR: everything you need to know

Webinar

Medtech post-market essentials

Questions about the EU IVDR

What is the EU IVDR?

Regulation (EU) 2017/746 is the European Union's law for placing an in vitro diagnostic medical device on the EU market. It sets the safety and performance requirements a device must meet, the performance evaluation and technical documentation that show it, and the conformity assessment, through a notified body for every class except non-sterile Class A.

Do we need a notified body to CE mark an IVD?

For Class B, C and D, and for sterile Class A devices, yes. The notified body audits the quality management system, assesses the technical documentation and issues the certificates the declaration of conformity rests on. Non-sterile Class A devices are self-declared by the manufacturer. Class D devices also go to an EU reference laboratory where one is designated.

What changed from the IVDD to the IVDR?

The IVDR replaced the IVD Directive in 2022 with four risk classes, so most IVDs that were self-declared under the Directive now need a notified body. Performance evaluation became an obligation through the device's life, the PSUR arrived for Class C and D, and UDI, EUDAMED registration and a person responsible for regulatory compliance were added.

What are the IVDR transition deadlines for legacy devices?

Devices on an IVDD certificate or declaration can stay on the market until 31 December 2027 for Class D, 2028 for Class C and 2029 for Class B and sterile Class A. Each needed an IVDR quality management system by May 2025, then a notified body application and written agreement by its class's deadlines.

What is a performance evaluation under the IVDR?

The evidence that the device does what the manufacturer claims, in three parts: the scientific validity of the link between the analyte and the clinical condition, analytical performance and clinical performance. It follows a plan, ends in a report in the technical documentation and is updated through post-market performance follow-up.

Does the IVDR require ISO 13485?

Article 10 asks for a quality management system without naming a standard. EN ISO 13485:2016 with amendment A11:2021 is the harmonised standard for it, so a system built to ISO 13485 is presumed to meet the requirements the standard covers and is where most notified bodies start. The conformity assessment still runs on top of the certificate.

Can we add the EU IVDR to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the procedures, complaints, CAPAs and performance evaluation records you already hold against the IVDR's articles, alongside ISO 13485 and the EU MDR if you run them too. Each requirement is answered once and the evidence exports by article.

When is the notified body audit?

Bring the audit date and your current procedures. We will show you the IVDR assessed against them article by article, with the gaps listed and the evidence exported as the notified body samples it.

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