IVDR (EU 2017/746) explained: what changes for IVD makers

The IVDR is Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. It replaced Directive 98/79/EC, the IVD Directive (IVDD), on 26 May 2022, and now governs the placing on the market, making available on the market, and putting into service of in vitro diagnostic medical devices across the European Union. The regulation tightens the conformity-assessment route by class, introduces a single device database (EUDAMED), and brings most IVDs into the Notified Body system that IVDD largely kept outside it. This page sets out what IVDR requires of an IVD manufacturer, what changed from IVDD, and where EUDAMED registration sits inside the conformity picture. It is reference material, not legal opinion.

What IVDR (Regulation EU 2017/746) is, and what it replaces

On 26 May 2022 IVDR became the operative EU framework for in vitro diagnostic medical devices, displacing the IVD Directive (98/79/EC) that had been in force since 1998. The regulation was adopted on 5 April 2017 alongside the Medical Device Regulation (Regulation (EU) 2017/745) and entered into force on 26 May 2017, with a five-year transition before its date of application. The Commission’s in vitro diagnostic medical devices portal tracks implementation status and harmonised standards.

An in vitro diagnostic medical device, as Article 2(2) of IVDR sets out, is any device intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body. The output of that examination is information about a physiological or pathological process or state, a congenital physical or mental impairment, predisposition to a medical condition or disease, suitability for a particular recipient, or compatibility of a treatment. Reagents, calibrators, control materials, kits, instruments, apparatus, software, and specimen receptacles all fall in scope.

The shift from a directive to a regulation matters in itself: a regulation is directly binding across all Member States without national transposition. IVDD by contrast sat as a baseline that each Member State implemented through its own national law. IVDR removes that layer and applies uniformly. Member State competent authorities still enforce the rules; the substantive rules are now common.

IVDR risk classification: Classes A, B, C, D (Annex VIII)

Where IVDD used a list-based regime that captured a narrow set of high-risk products (Annex II List A, List B, and self-tests), IVDR introduces a four-class risk hierarchy modelled on the EU’s wider medical-device rules. Annex VIII of IVDR sets out seven classification rules, applied in turn, that assign every IVD to Class A, B, C, or D.

The class drives the conformity-assessment route. Most Class A devices self-certify against IVDR’s general safety and performance requirements: the manufacturer issues an EU declaration of conformity and applies the CE mark. Class A devices that are sterile or that are intended for self-testing or near-patient testing carry additional Notified Body involvement under Article 48. Classes B, C, and D require Notified Body assessment of the quality management system and, for higher-risk classes, of the technical documentation and the performance evaluation. Class D devices also undergo verification by an EU reference laboratory under Article 100.

MDCG 2020-16 Rev. 2 sets out the EC’s working interpretation of the Annex VIII rules and is the operative reference for borderline cases. The Commission’s UDI Helpdesk classification page covers the practical mapping question.

Industry analyses put the share of IVDs requiring Notified Body assessment at roughly 80 to 90 per cent under IVDR, against the 10 to 20 per cent under the IVDD list regime. The transition extensions in section 4 below were drafted in part to relieve the resulting capacity squeeze.

What IVDR changes from IVDD

Five structural shifts separate IVDR from IVDD: classification, Notified Body coverage, technical documentation and clinical evidence, post-market surveillance, and traceability through UDI and EUDAMED.

Classification. IVDD used Annex II lists; IVDR uses Annex VIII rules. The list approach captured a narrow group of high-risk diagnostics; the rules approach captures every IVD and assigns it a class. The PAA-cited difference between IVDD and IVDR starts here.

Notified Body coverage. Under IVDD, roughly 10 to 20 per cent of IVDs went through a Notified Body. Under IVDR, the figure is closer to 80 to 90 per cent. That has driven a sustained capacity squeeze, which the 2022 and 2024 transition extensions were drafted to relieve.

Technical documentation and clinical evidence. IVDR Annex II prescribes the structure of the technical file; Annex XIII covers the performance evaluation. The clinical-evidence chapter (Articles 56 to 61) requires manufacturers to establish, document, and update scientific validity, analytical performance, and clinical performance, captured in a Performance Evaluation Report (PER) under Article 56. There is no IVDD analogue for the PER.

Person Responsible for Regulatory Compliance (PRRC). IVDR Article 15 obliges manufacturers (including micro and small enterprises with adapted access arrangements) to designate at least one PRRC with documented qualifications. Article 15(3) makes the PRRC personally responsible for the conformity check before each device is released and for the technical documentation. There is no equivalent under IVDD. MDCG 2019-7 covers PRRC qualification.

Post-market surveillance and vigilance. Chapter VII of IVDR (Articles 78 to 93) establishes a structured PMS system, with a PMS plan in Annex III, periodic safety update reports (PSUR) for higher-risk classes, and trend reporting. IVDD vigilance was lighter and less prescriptive. MDCG 2022-9 covers the threshold for a “significant change” that triggers re-assessment.

Traceability. IVDR Article 24 mandates the UDI system for IVDs, with Article 25 establishing the UDI database and Article 30 establishing EUDAMED. IVDs are now individually identifiable in a single EU database. IVDD carried no equivalent.

IVDR transition timelines: 26 May 2022 and the 2024/1860 extensions

The IVDR’s date of application was 26 May 2022, set in Article 113. Two amendments since then have extended the transition for legacy IVDs that hold valid IVDD certificates or that sit in higher classes than IVDD would have required, in recognition of Notified Body capacity constraints.

Regulation (EU) 2022/112, adopted in January 2022, introduced the first class-stratified extension. IVDs with valid IVDD declarations or certificates issued before 26 May 2022 could remain on the market beyond that date, with end dates staggered by class: Class D until 26 May 2025, Class C until 26 May 2026, Class B and sterile Class A until 26 May 2027. Devices first placed on the market under IVDR rules carried no extension.

Regulation (EU) 2024/1860, published on 9 July 2024, did two things. It accelerated EUDAMED’s mandatory use by making each module binding 6 months after the Commission publishes a notice declaring it fully functional, ahead of full database completion. It also extended the IVDR transition once more for higher-risk and lower-risk classes, on conditions: the manufacturer must have an applicable quality management system in place by 26 May 2025, must lodge a formal application with a Notified Body by certain dates, and must have a written agreement with the Notified Body signed by the corresponding deadline. Where those conditions are met, end dates move to 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and sterile Class A.

MDCG 2022-8 sets out the EC’s interpretation of the 2022/112 conditions; further MDCG notes on 2024/1860 are being published as modules come online.

Technical documentation, clinical evidence, and performance evaluation under IVDR

IVDR builds its technical-documentation chapter around three legs: analytical performance, clinical performance, and scientific validity. Together they constitute the performance evaluation that Article 56 defines. The Performance Evaluation Plan (PEP) required by Article 56(2) sets out what each leg will demonstrate and how; the Performance Evaluation Report (PER) records the result.

Article 57 governs scientific validity, the link between the analyte the device measures and the clinical or physiological condition it claims to inform. The evidence base may be peer-reviewed literature, expert opinion, proof-of-concept studies, or, for novel analytes, original studies. Article 58 covers analytical performance: sensitivity, specificity, accuracy, precision, limits of detection and quantification, linearity, and interference. Article 59 covers clinical performance, including diagnostic sensitivity and specificity, predictive values, and likelihood ratios. Article 61 and Annex XIII prescribe the clinical-evidence file.

For higher-risk devices the PER is supplemented by post-market performance follow-up (PMPF), an iterative process that mirrors PMCF for medical devices under MDR. The Periodic Safety Update Report (PSUR) under Article 81 captures the PMS findings periodically; for Class C and Class D devices the PSUR is updated at least annually and made available to the Notified Body and competent authorities.

Class C and Class D devices also require a Summary of Safety and Performance (SSP) under Article 29(4), drafted in language clear to the intended user (clinician, lay user for self-tests, or both), and made publicly available through EUDAMED. The SSP is the IVDR counterpart to the SSCP that MDR requires for implantable and Class III devices.

MDCG 2022-2 covers PEP and PER expectations and is the EC’s principal guidance on performance evaluation. MDCG 2022-9 covers the threshold for a significant change that requires re-assessment or a fresh conformity route.

UDI and EUDAMED registration under IVDR Article 24

IVDR Articles 24 to 30 set out the UDI and EUDAMED architecture for in vitro diagnostics. Article 24 mandates the UDI system; Article 25 establishes the UDI database; Article 26 covers device registration; Article 27 establishes the electronic system for the registration of economic operators; Article 28 issues the Single Registration Number (SRN); and Article 30 establishes EUDAMED as the European database for medical devices, shared with the MDR.

UDI under IVDR works through three identifier levels. The Basic UDI-DI groups devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics. It is a device-family identifier that anchors the technical-documentation file and the EUDAMED device record. The UDI-DI identifies a specific commercial configuration of a device. The UDI-PI carries production-level identifiers: lot or batch number, serial number, and manufacture and expiry dates as applicable. Issuing entities recognised by the Commission (GS1, HIBCC, IFA, ICCBBA) administer the UDI-DI ranges; the manufacturer assigns the Basic UDI-DI inside its own range, against the structural rule the issuing entity sets. MDCG 2018-1 Rev. 4 is the operative reference.

EUDAMED has six modules: Actor registration, UDI and Devices, Notified Bodies and Certificates, Vigilance, Clinical Investigations and Performance Studies, and Market Surveillance. An IVD manufacturer hits Actor first, then UDI and Devices once the SRN is issued. Higher-risk classes interact with the Notified Bodies and Certificates module through the Notified Body’s own submission. The Vigilance and Market Surveillance modules come online as the Commission completes them under the Regulation (EU) 2024/1860 acceleration mechanism. The Commission’s EUDAMED Information Centre carries the current module status and user guides.

Legacy IVDs that carry valid IVDD certificates use the EUDAMED-DI assignment introduced to cover devices that never received an MDR or IVDR Basic UDI-DI: a transitional identifier the manufacturer can use to register a legacy device record in EUDAMED without rebuilding the UDI hierarchy from scratch.

For the step-by-step mechanics (what each record contains, how the SRN is acquired, how Basic UDI-DI feeds the device record), see the EUDAMED registration step under IVDR in the registration pillar.

Economic operator roles under IVDR: manufacturer, EU rep, importer, distributor, PRRC

IVDR Articles 10 through 16 set out the responsibility chain for IVDs placed on the EU market.

Article 10 imposes the manufacturer’s general obligations: the QMS, the post-market surveillance system, the technical documentation, the declaration of conformity, the CE marking, the registration in EUDAMED, the designation of the PRRC under Article 15, and financial cover proportionate to risk. The manufacturer is the legal entity whose name appears on the device.

Article 11 defines the EU authorised representative. Manufacturers established outside the EU appoint an authorised representative inside the EU, who shares specified obligations with the manufacturer under a written mandate. The representative’s name and SRN appear on the device and in EUDAMED alongside the manufacturer’s.

Article 13 covers the importer. The importer verifies that the device carries the CE mark, that the manufacturer is identified, that the authorised representative is named where applicable, and that the device is accompanied by IFU and labelling. The importer’s details are registered in EUDAMED.

Article 14 covers the distributor. The distributor checks the device’s CE marking and accompanying documentation at the point of making it available and acts on complaints, non-conformities, recalls, or withdrawals.

Article 15 establishes the PRRC. Each manufacturer must designate at least one PRRC with documented qualifications: a degree in a relevant scientific or medical discipline plus one year of relevant experience, or four years of relevant experience in regulatory affairs or quality management without the degree. Article 15(3) makes the PRRC personally responsible for the conformity check before release and for the technical documentation.

Article 16 covers special obligations. Where a distributor, importer, or other person assumes responsibility for a device on its own behalf (relabelling, repackaging, or modifying), Article 16 treats them as a manufacturer for that device.

MDR vs IVDR: where they overlap, where they diverge

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) were adopted together on 5 April 2017 and share most of their regulatory architecture: Notified Body assessment, the UDI system, EUDAMED, the PRRC, post-market surveillance, vigilance, and a structured technical-documentation chapter. They diverge on device scope, classification, the framing of evidence, and dates of application.

MDR covers medical devices acting on or in the human body: implants, surgical instruments, electronic monitors, software intended for medical purposes. IVDR covers diagnostics performed in vitro on samples taken from the body. A device that does both (for example, a software product that processes lab data and also outputs decisions on imaging) sits in the regulation that matches its principal intended purpose.

Classification is the most visible difference. MDR has Classes I, IIa, IIb, and III, set by Annex VIII rules driven by duration of contact, body system, and active or non-active operation. IVDR has Classes A, B, C, and D, set by separate Annex VIII rules driven by individual and public-health risk.

Evidence framing differs. MDR talks about clinical evaluation under Article 61 and Annex XIV: a Clinical Evaluation Plan and Clinical Evaluation Report (CEP and CER). IVDR talks about performance evaluation under Articles 56 to 61 and Annex XIII: a Performance Evaluation Plan and Performance Evaluation Report (PEP and PER). The architecture is parallel; the content is different.

How EUDAPrep prepares the EUDAMED registration step for IVDs

EUDAPrep prepares the EUDAMED submission for in vitro diagnostic devices registered under IVDR. The tool ingests the manufacturer’s source documents (instructions for use, label, declaration of conformity, technical documentation, and Notified Body certificate where applicable) and maps the IVD-relevant content to the fields the EUDAMED data dictionary requires.

The mapping engine handles the IVDR-specific differences from MDR: performance evaluation rather than clinical evaluation, the SSP rather than the SSCP, IVDR Article 24 UDI rather than MDR Article 27 UDI, IVDR Article 30 EUDAMED rather than MDR Article 33. Where the data dictionary admits a deterministic rule (Basic UDI-DI structural validation, EMDN code candidacy by stated intended purpose, risk-class consistency with Annex VIII) the rule fires without LLM involvement. Where the source document is unstructured prose (a paragraph from a Performance Evaluation Report, a free-text label section) the LLM-assisted extraction layer surfaces candidate values, with an AI-use disclosure consistent with Article 50 of the AI Act. Where neither produces a confident match, the field is flagged for manual review.

Pre-export validation runs against the EC’s published XSD schema and business rules, so the file that comes out has been checked against the rules the portal will apply. The user reviews, the PRRC signs off under IVDR Article 15(3) where required, downloads the XML, and uploads it through the EUDAMED portal. EUDAPrep does not submit to EUDAMED.

The mechanics of the registration sequence (actor first, then SRN-gated device records, then certificate links for higher-risk classes) are covered in the EUDAMED registration step under IVDR.