EU IVDR · Regulation (EU) 2017/746 on in vitro diagnostic medical devices
EU IVDR compliance consulting for diagnostics backed by evidence a notified body accepts.
Place your tests on the EU market under Regulation (EU) 2017/746 with the proof the IVDR asks for: scientific validity, analytical and clinical performance, an Article 10(8) quality management system and technical documentation built to be read, not returned. Sterling's expert and experienced consultants classify your range, build the system and the files with your team in 60+ countries, and stay with you through the notified body's assessment and after it. We ensure successful IVDR CE marking for our clients.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced IVD regulatory consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling prepares the QMS, the performance evaluation and the technical documentation; the notified body assesses and certifies, and you affix the CE mark under your own declaration of conformity
8,100+ client engagements in 60+ countries.
EU IVDR client experience
What it is
What is the EU IVDR and what is it used for?
The IVDR is the European Union's law for in vitro diagnostics: reagents, kits, calibrators and controls, analysers, software, specimen receptacles and self-tests used to examine samples taken from the human body. It applies directly in every Member State to any manufacturer placing such a device on the EU market, wherever it is based, and it replaced Directive 98/79/EC on 26 May 2022.
Its central change is risk-based classification. Seven rules in Annex VIII sort each device into class A, B, C or D, and a notified body is now involved for every class B, C and D device and for class A devices placed on the market sterile. Many tests once self-declared under the Directive now need that assessment, and Regulation (EU) 2024/1860 records that notified body capacity is "still not sufficient" for the "large number" of devices concerned. The evidence changed too: a performance evaluation, kept current by post-market performance follow-up (PMPF), sits beside an Article 10(8) quality management system, UDI and EUDAMED registration, a person responsible for regulatory compliance (PRRC) and vigilance.
Current text. Regulation (EU) 2017/746 has applied since 26 May 2022. Regulation (EU) 2022/112 of 25 January 2022 first staggered the transition for legacy devices by class, and Regulation (EU) 2024/1860 of 13 June 2024 set the dates that now apply, from 31 December 2027 for class D to 31 December 2029 for class B and sterile class A, under strict conditions. The same Regulation phased in EUDAMED, whose first four modules have been mandatory since 28 May 2026. On 16 December 2025 the Commission proposed a simplification of the MDR and the IVDR, COM(2025) 1023; as of September 2026 it has not been adopted, so today's text and deadlines apply.
Who it is for
Who needs to comply with the EU IVDR?
The heaviest duties fall on the legal manufacturer, wherever it is established; authorised representatives, importers and distributors carry duties of their own, and health institutions making their own tests are conditionally exempt. Most organisations that call us start from one of four places:
- You are bringing a new test to the European market. A manufacturer in Pune, Singapore or Manila needs each device classified, a performance evaluation with data behind it, an Article 10(8) quality management system, a PRRC, UDIs, an EUDAMED registration and, for every class except plain class A, a notified body with capacity.
- Your test was self-declared under the Directive and now needs a notified body. Regulation (EU) 2024/1860 keeps such devices on the market until the end of 2027, 2028 or 2029 by class, but only where its conditions are met in time.
- The notified body is asking questions your file cannot answer yet. A performance evaluation assembled from old verification reports, clinical performance claims without data, a class disputed under Rule 3 or Rule 4, or a class D assay waiting on batch-release arrangements.
- You run a laboratory in a health institution and make your own tests. Article 5(5) lifts most of the Regulation from in-house devices only while all its conditions are met; the last of them, the justification that no equivalent device on the market meets the patients' needs, applies from 26 May 2028.
Business benefits
How EU IVDR compliance protects market access and the results clinicians rely on
An in vitro diagnostic is only as good as the result it reports. The programme is tested when the notified body opens the performance evaluation, when a laboratory reports an unexpected pattern of results and when a hospital's procurement team checks the certificate. We build for all three.
- Performance evidence that holds togetherScientific validity, analytical and clinical performance argued in one report, each claim in the instructions for use traced to data a reviewer can find.
- One quality system under two frameworksEN ISO 13485:2016 with A11:2021 carrying the Article 10(8) additions, so the notified body audits one system, not a certificate plus extra procedures.
- Class D without surprises at releaseBatch test reports, samples, reference-laboratory arrangements and release timing planned before launch, not improvised at the first lot.
- Surveillance that updates the evidenceComplaints, literature, field data and external quality assessment results feeding PMPF, so the performance evaluation and, for classes C and D, the periodic safety update report (PSUR) are refreshed at least annually.
- Traceability that works in a recallUDIs on labels, EUDAMED records and distribution data linked, so a field safety corrective action reaches the affected lots and no others.
- Notified body time used wellWith capacity scarce, a file that answers questions before they are asked shortens review rounds and protects your place in the queue.
Measure what matters: review rounds per submission, days from complaint to reportability decision, PSURs on time, lots released without query.
Requirements
What are the main EU IVDR requirements?
The obligations that shape an IVD manufacturer's programme sit in a handful of articles and annexes, mapped below to practice. Notified bodies read your files against the Regulation, the harmonised standards and the guidance of the Medical Device Coordination Group (MDCG).
| Article or Annex | What it requires of you | What it looks like in practice |
|---|---|---|
| Annex VIII · Classification rules | Place each device in class A, B, C or D under the seven Annex VIII rules, by intended purpose; the class decides the route and how closely a notified body looks | A rationale per device citing the rule: blood screening, high-risk transmissible agents and ABO, Rhesus, Kell, Kidd and Duffy grouping in class D; companion diagnostics, genetic and cancer tests in class C; self-tests in class C, except pregnancy, fertility, cholesterol and certain urine tests in class B; IVD instruments and specimen receptacles in class A |
| Article 10(8) · Quality management system | Put in place and maintain a QMS addressing at least thirteen aspects, from the regulatory compliance strategy and supplier control to risk management, performance evaluation with PMPF, UDI verification, surveillance, vigilance, CAPA and monitoring | EN ISO 13485:2016 with A11:2021, harmonised for the IVDR since 2022, plus IVDR-specific procedures; for class B, C and D devices the notified body audits the system and keeps it under surveillance |
| Article 10(4), Annexes I, II and III · Technical documentation | Keep technical documentation up to date with the Annex II elements and the Annex III surveillance documentation, showing how each Annex I general safety and performance requirement is met | An Annex I checklist naming the evidence, a risk management file to EN ISO 14971:2019 with A11:2021 (harmonised for the IVDR since 2022), labels, instructions for use, verification and stability data, kept at least ten years after the last device is placed on the market |
| Article 56 and Annex XIII · Performance evaluation | Demonstrate scientific validity, analytical performance and clinical performance in a performance evaluation report, kept current as a continuous process fed by PMPF | A performance evaluation plan and report, analytical studies, clinical performance data from studies, literature or routine testing, and a PMPF plan; for classes C and D the report is updated at least annually and a summary of safety and performance is validated by the notified body (Article 29) |
| Article 15 · Person responsible for regulatory compliance | At least one PRRC with a relevant degree and a year of IVD regulatory or quality-system experience, or four years of such experience; micro and small enterprises may instead have the person permanently and continuously at their disposal | A documented appointment and sign-offs the PRRC genuinely gives |
| Articles 24, 26 and 28 · UDI, registration and EUDAMED | Assign a Basic UDI-DI and a UDI (UDI-DI plus UDI-PI) through a designated issuing entity, obtain a single registration number, and register devices in EUDAMED, the European database of Article 30 | UDI carriers on labels of class D devices since 26 May 2023 and class B and C since 26 May 2025, class A from 26 May 2027; EUDAMED's first four modules mandatory since 28 May 2026, with devices already on the market entered no later than six months after that date |
| Article 48, Annexes IX to XI, Articles 17 and 18 · Conformity assessment, declaration and CE mark | Plain class A: the manufacturer documents and declares conformity itself. Class B, C, D and sterile class A: a notified body designated under the IVDR takes part, under Annex IX or, for some classes, Annexes X and XI; for class D an EU reference laboratory is involved where designated, experts are consulted for a first-of-type device without common specifications, and the Article 50 scrutiny mechanism applies | The notified body's certificates, an EU declaration of conformity (Article 17) and the CE marking (Article 18, Annex V); for class D, test reports and samples for each batch, released unless the notified body decides otherwise within the agreed time, at most 30 days after receiving the samples |
| Articles 78 to 83 and Annex III · Surveillance and vigilance | Run a post-market surveillance system within the QMS on each device's quality, performance and safety; class A and B keep a PMS report, class C and D a PSUR updated at least annually; report serious incidents and field safety corrective actions within the Article 82 time limits, and trends under Article 83 | A PMS plan per device or family, complaint logs, literature and external quality assessment results reviewed on schedule, a PMPF plan, a PSUR calendar and a vigilance procedure with each reportability decision recorded |
What does useful EU IVDR evidence look like?
Per device, a classification rationale naming the rule; procedures mapped to each Article 10(8) aspect; a performance evaluation whose claims match the instructions for use; a live risk management file; stability and verification data indexed to Annex I; UDI labels; certificates; the latest PSUR or PMS report; a vigilance register. We build them from your real assays and instruments, in Effivity from the first workshop.
EU IVDR requirements explained, article by articleCE marking process
How do you get CE marked under the EU IVDR?
Classify, build the evidence and the system, then apply to a notified body designated under Regulation (EU) 2017/746 whose scope covers your device. Sterling prepares the QMS, the performance evaluation, the files and your team; the notified body assesses and certifies; the declaration and the CE mark are then yours.
- 01Classify each device and fix the route.Intended purpose, Annex VIII rule and class, conformity assessment route, the economic operators involved and any legacy date under Regulation (EU) 2024/1860.
- 02Gap analysis: test the system, the evidence and the files against the Regulation.The gap analysis compares the QMS with Article 10(8) and EN ISO 13485, the files with Annexes I to III, and performance evaluation, surveillance, vigilance, UDI and PRRC arrangements with the IVDR; what works is kept, and actions, owners and dates are agreed.
- 03Build the evidence and put the system to work.Performance evaluation plan and report, analytical and clinical performance data, risk management file, labelling, PMS and PMPF plans, the PRRC appointment, UDIs and your EUDAMED actor registration.
- 04Run the internal audit and a mock file review.Internal audit against the IVDR and EN ISO 13485, management review and a mock notified body review of a representative file, with our findings raised first and closed with evidence.
- 05Pass the notified body's assessment, then declare and mark.Application, QMS audit and technical documentation assessment, with the EU reference laboratory and experts involved for class D where the rules require; deficiencies answered and certificates issued; you then sign the declaration, affix the CE mark and register the devices in EUDAMED.
- 06Keep the CE mark valid.PMPF, PSURs or PMS reports and vigilance run on their calendars, the notified body keeps the QMS under surveillance and releases class D batches, and changes are assessed with it before they are made.
Before paying anyone, confirm who will assess your devices. A notified body must be designated under Regulation (EU) 2017/746 and listed in the Commission's NANDO database for your device type; certificates from any other organisation carry no legal weight, and an ISO 13485 certificate covers a quality system, not a device. How to choose a credible EU IVDR provider · The certification buyer's checklist
Cost
How much does EU IVDR compliance cost?
The fee follows your device classes, how many devices need files, the state of your performance data and the route the notified body must follow. A class B assay on an established ISO 13485 system is a different programme from a class D blood-screening test with no clinical performance data. What does not change: every component visible, the fee fixed.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Classes and number of devices, files and performance evaluations to build or repair, the state of the QMS, sites, and how much work your team takes on (Design™ or Drive™) |
| Notified body assessment | The notified body's own fees for application, QMS audit days, technical documentation assessments, surveillance and class D batch verification, shown separately |
| Performance data and studies | Analytical studies, specimen sourcing, clinical performance studies where literature and routine-testing data fall short, stability work, translations and authorised representative fees |
| Internal resources | Scientific, quality and regulatory time, the PRRC's capacity, labelling changes and verification runs |
| Software and learning | Included in every Sterling engagement: Effivity for the system and Sterling Academy access for your people; users, courses and access period confirmed in the proposal |
| Continued support | Sustain™: PMPF and PSUR cycles, surveillance-audit preparation, internal audits, regulatory monitoring and refresher learning |
What moves the price
- Device classes, and how many files and performance evaluations are needed
- Class D, companion diagnostic and self-testing devices in the range
- Whether clinical performance data exist, and whether a certified ISO 13485 system already runs
- A manufacturer outside the EU working through an authorised representative
- The deadline: a legacy date, a launch or a tender
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, written down
- Notified body, study and authorised representative fees identified separately
- Effivity, training and Academy access itemised, at no additional cost
- Payments linked to deliverables rather than dates
- One all-inclusive proposal. No surprises, ever
Timeline
How long does EU IVDR compliance take?
Expect six to eighteen months to be ready for a notified body, then its own review, which for a first application depends on its capacity and on the questions your file raises. A maker of non-sterile class A instruments sits at the short end and needs no notified body at all; a class D or companion diagnostic manufacturer that must generate clinical performance data sits at the long end. The plan runs backwards from the evidence, with milestones in Effivity.
| Phase | What determines the pace |
|---|---|
| Classification and gap analysis | Access to design history, verification and validation data, existing files and certificates |
| Studies, build and documentation | Specimen availability, analytical and clinical performance study lead times, stability data and scientific capacity |
| Evidence, internal audit and review | The QMS operating long enough to produce complaint, CAPA, supplier and training records, then internal audit and management review |
| Notified body assessment and CE marking | Application acceptance, audit scheduling, review rounds and, for class D, reference-laboratory and expert involvement, then certificates and the declaration |
If a legacy date, a launch or a distributor's qualification drives the programme, say so at the first call. Nobody can reliably promise a CE-marking date before reading your performance data.
Challenges
Common EU IVDR implementation challenges
IVDR programmes tend to stall on five problems. Each has a practical answer.
The performance evaluation is a pile of old verification reports.
We rebuild it around what Article 56 asks you to show: the analyte's link to the clinical condition, correct detection or measurement, and results that correlate with the condition in the intended population. Gaps are closed with literature, routine-testing data or a performance study.
The device was self-declared under the Directive, and nobody here has faced a notified body.
We run a mock assessment early, fix what it finds and prepare your team for the audit and the review rounds.
Class D logistics were left until the end.
Batch test reports, samples, reference-laboratory arrangements and release timing are agreed with the notified body before the first lot, so supply is not held at release.
An ISO 13485 certificate was taken as proof of IVDR readiness.
It is the right foundation, but the Regulation requires more: a regulatory compliance strategy, the Annex I requirements process, performance evaluation with PMPF, UDI verification, a PRRC, PSURs, vigilance reporting and EUDAMED. We add them to the system you already run.
Legacy dates are close and notified body slots are scarce.
We confirm the Regulation (EU) 2024/1860 conditions are met, sequence devices by class and date, build review-ready files and prepare deficiency responses so each round moves the file forward.
Your engagement
What your EU IVDR engagement includes
The engagement covers everything between today's position and a CE mark you can keep: the system, the evidence, the people and the software, from one team for one all-inclusive proposal.
Classification, gap analysis and plan
Every device classified with its rule and route, each IVDR obligation tested against today's position, and actions, owners and dates agreed.
QMS, performance evaluation and technical documentation
Procedures on EN ISO 13485 with the IVDR additions, performance evaluation plans and reports, Annex II and III files and the risk management file, built with your scientists on Sterling's template sets.
Effivity ISO & GRC software
Your QMS, files, registers and surveillance calendars run in Effivity from day one, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for the people who will audit the system, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Internal audit and management review
Conducted or facilitated as agreed, against the Regulation and the standard, with findings closed before the application goes in.
Notified body readiness and support
Application preparation, answers to nonconformities and deficiency letters, class D release planning and PRRC coaching, until the certificates are issued.
Certification decisions remain with the notified body; the declaration of conformity is signed by you, the manufacturer.
How we deliver
How Sterling supports your EU IVDR implementation
Each EU IVDR engagement runs on Sterling OS™, our delivery operating system: five phases with defined deliverables, decision owners and evidence. Your team decides how much of the work it carries, while method, software and accountability remain constant.
- 01Design™Guided implementation: your regulatory, quality and R&D teams build the system, the performance evaluation and the files with Sterling's structure, templates, workshops and coaching.
- 02Drive™Fully managed consulting: Sterling consultants carry the agreed documentation, evidence compilation and application preparation alongside your process owners.
- 03Sustain™Life after CE marking: PMPF and PSUR support, readiness for surveillance audits, internal audits, regulatory monitoring and refresher training.
- 04Automate™The programme in Effivity: procedures, technical documentation, performance evaluation files, UDI and certificate registers, complaints, vigilance, CAPA and audits in one workspace.
- 05Revise™Rule changes and range changes: legacy transitions by class, EUDAMED modules as they become mandatory, the simplification regulation if adopted, new assays and reclassifications.
In week one we agree the engagement team, the weekly working session, the deliverables and the decision owners, and track progress against them, so a missing stability study surfaces in month two, not in a deficiency letter.
How Sterling OS™ worksOften combined with
Standards organisations pair with EU IVDR 2017/746
- 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
- ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
- CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
- EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
- FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.
- GMP (PIC/S, EU, WHO)GMP compliance consulting for medicine manufacturers: quality systems, batch records and controls ready for your national regulator's inspection on any day.
Effivity · EU IVDR quality management software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of Regulation (EU) 2017/746.
Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries, comes with every Sterling EU IVDR engagement. Your consultant configures it within the agreed scope, so procedures, technical documentation, performance evaluation files, registers, complaints, vigilance, CAPA and audits sit in one place and the notified body reviews a system in daily use, not a binder. The subscription is included with the engagement, at no additional cost.
Article 10(8), aspect by aspect
Each of the thirteen QMS aspects linked to its procedure, owner and records, so the notified body's audit follows your own map.
A classification register per device
Intended purpose, rule, class and route recorded per device with its rationale, so a new claim or label change prompts a class check.
Annex II and III files under control
Device description, labelling, design and manufacturing information, the Annex I checklist, risk management and verification data held as versioned, approved sets.
From scientific validity to PMPF in one file
The plan, the evidence, the report and its annual update for classes C and D, with PMPF findings flowing back in.
Sign-offs with a trail
Release checks, documentation approvals and vigilance reports routed to the PRRC, each decision dated and traceable.
UDI and EUDAMED status
Basic UDI-DI and UDI assignments per device and packaging level, label checks, your single registration number and each EUDAMED registration with its deadline.
PMS plans, PSURs and vigilance
A PMS plan per device or family, complaints, literature and field data logged against it, the PSUR or PMS report calendar, and serious incidents assessed with the decision recorded.
Suppliers, people, audits and corrective action
Critical suppliers evaluated, competence linked to Sterling Academy, internal audits, management review and CAPA closed with proof of effect; forms adapted without code.
What this means at the audit
At a notified body audit the requests are predictable: the procedure behind each Article 10(8) aspect, the performance evaluation of sampled devices, the latest PSUR or PMS report, the vigilance register and supplier evaluations. Effivity answers each with a screen, dated, owned and evidenced, not a folder assembled the week before. Sustain™ continues in the same workspace, so surveillance meets a system that kept running.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Existing procedures, records and registers migrated rather than retyped
- Admin and user training for your quality, R&D and regulatory teams
- Modules for ISO/IEC 27001, ISO 14001, ISO 45001 and more when you integrate other standards
EU IVDR client experience
Client letters on file, available on request.
Signed client letters for EU IVDR are available on request. The client feedback wall lists every letter by standard.
Programmes with the EU IVDR in scope
How the IVDR fits a diagnostics quality programme.
- 01Integrated management systems
In vitro diagnostics: ISO 13485, ISO 14971 and the EU IVDR as one system
How a programme of this kind runs: EN ISO 13485:2016 with A11:2021 provides the quality system the notified body audits and EN ISO 14971:2019 with A11:2021 the risk process; the Article 10(8) additions, the performance evaluation and PMPF plan, the Annex II and III files, the PRRC, UDI and EUDAMED are built on that base. Where the organisation also runs a medical laboratory, ISO 15189 shares document control, training and internal audit, so one evidence base serves the notified body and the accreditation body.
Sterling Academy · EU IVDR e-learning
Train everyone whose work shows up in a test result, not only the regulatory team.
Sterling Academy teaches the IVDR to the whole workforce and to the people who run the system, through video lessons, practice checkpoints and a final exam, with a numbered Certificate of Completion per learner, verifiable online. Sterling consulting clients receive preferential Sterling Academy course access and special pricing through their consultant, including complimentary awareness training for their people as part of the engagement.
- EU IVDR awareness for every employee, recorded as competence evidence a notified body can review
- Practitioner learning for regulatory affairs, quality, R&D and the PRRC
- Internal auditor training for your audit team, as applicable to your standard, delivered within the engagement
- Progress by department and a training status report ready for any auditor
- New starters trained on arrival, so records stay current between surveillance audits
- A Sterling consultant on hand when a learner has a question
Keep exploring
Explore more about EU IVDR 2017/746
Watch a video on how to comply with EU IVDR here.
Watch a video on EU IVDR requirements here.
Why Sterling
Want successful EU IVDR compliance? Come to Sterling.
IVD manufacturers come to us at every stage: before a first submission, between deficiency rounds, or with legacy products and a date on the calendar. Wherever you design, make or sell, one Sterling team builds the system, the evidence and the habits that keep the CE mark.
Across 60+ countries since 2003
Management systems for manufacturers, laboratories, distributors and healthcare organisations, from offices in 21 countries, with one engagement team accountable across your markets.
All-inclusive proposal
Consulting, Effivity, training and Academy access in a single proposal, with notified body, study and authorised representative fees shown separately. No surprises, ever.
Evidence built from your assays
Performance evaluations, files and risk records built from how your tests are really developed, made and used, indexed the way a reviewer reads them.
Expert and experienced consultants
Since 2003 our consultants have advised on management systems for organisations whose products are regulated. They know the questions a notified body asks, and they build the answers into your system from the first draft.
The Sterling Promise
What our EU IVDR compliance success guarantee means
We stay with you until the agreed IVDR outcome is reached: the quality system operating, the files ready for review, the notified body's findings answered, the certificates issued and the CE mark on your label under your own declaration. Plain explanations, included software and learning for your people make the investment a capability that outlasts the project.
The engagement letter names the devices, the scope, the outcome and each party's responsibilities. Your organisation provides accurate information and puts the agreed controls into use. The notified body assesses conformity and keeps its certification decision; the declaration of conformity is yours to sign. Our commitment covers the agreed compliance support, not a notified body's timetable.
After CE marking
What happens after CE marking under the EU IVDR?
The obligations turn into a calendar. Surveillance and PMPF run continuously and feed the performance evaluation; class C and D devices update the performance evaluation report and the PSUR at least annually, class A and B devices keep their PMS report current; incidents and trends are reported under Articles 82 and 83; the notified body keeps the quality system under surveillance and releases each class D batch; and Article 10a requires at least six months' notice of a supply interruption that could seriously harm patients or public health.
Under Sterling OS™ Sustain™ we run that calendar with you: PMPF and PSUR support, vigilance reviews, internal audits, surveillance-audit preparation and regulatory monitoring, so the system the notified body certified is still the one in use at its next visit.
FAQs
Frequently asked questions about the EU IVDR
Is there such a thing as EU IVDR certification?
Not in the sense of an ISO certificate. What the market requires is the CE mark, which the manufacturer affixes under its own EU declaration of conformity. For every class except plain class A, a notified body takes part and issues the certificates that declaration relies on. An "IVDR certificate" sold by a consultant or a management-system certification body is not one of them.
Which IVDs need a notified body under the IVDR?
All class B, C and D devices, and class A devices placed on the market sterile. Plain class A devices, such as IVD instruments, specimen receptacles and certain general laboratory products, are self-declared. The class comes from the seven Annex VIII rules applied to the intended purpose, and deciding it is the manufacturer's responsibility.
Does our ISO 13485 certificate make us IVDR compliant?
No, although it is the right foundation. EN ISO 13485:2016 with A11:2021 was harmonised under the IVDR in 2022, which gives a presumption of conformity only for the requirements it addresses. Performance evaluation and PMPF, UDI, the PRRC, PSURs, vigilance reporting and EUDAMED sit outside it. Its certificate is issued under accreditation, not under a notified body designation.
What are the legacy deadlines for IVDs?
Under Regulation (EU) 2024/1860, devices covered by a Directive 98/79/EC certificate and class D devices may stay on the market until 31 December 2027, class C devices until 31 December 2028, and class B and sterile class A devices until 31 December 2029. The conditions: continued compliance with the Directive, no significant change in design or intended purpose, no unacceptable risk, an Article 10(8) quality management system by 26 May 2025, an application by 26 May 2025 (certificate holders and class D), 26 May 2026 (class C) or 26 May 2027 (class B and sterile class A), and a written agreement with the notified body by 26 September of that year. IVDR surveillance, vigilance and registration rules already apply, and the sell-off date has gone.
How are class D devices treated differently?
They receive the closest scrutiny. Where the Commission has designated an EU reference laboratory for the device category, it verifies the performance claimed and tests batches; the first laboratories, designated by Implementing Regulation (EU) 2023/2713, took up these tasks on 1 October 2024 for markers of hepatitis and retrovirus, herpesvirus, bacterial and respiratory virus infections. Without a designated laboratory, notified bodies may still certify. Experts are consulted for a first-of-type device with no common specifications, and each batch is released through the notified body.
We are a hospital laboratory making our own tests. Does the IVDR apply to us?
Largely not, if you meet Article 5(5). Devices made and used only within a health institution established in the Union are exempt from the Regulation, except the relevant Annex I general safety and performance requirements, while every condition is met. All the conditions apply today except point (d), the documented justification that no equivalent device on the market meets the target patient group's needs, which applies from 26 May 2028.
Which EUDAMED obligations apply to IVDs today?
Four modules have been mandatory since 28 May 2026, after Commission Decision (EU) 2025/2371, published on 27 November 2025, declared them functional: registration of economic operators (actors), UDI and device registration, notified bodies and certificates, and market surveillance. Under the IVDR as amended by Regulation (EU) 2024/1860, manufacturers must enter their devices, legacy devices included, no later than six months after that date, and notified bodies their certificates within twelve months of it.
The Commission has proposed simplifying the IVDR. Should we wait?
No. The proposal of 16 December 2025, COM(2025) 1023, would amend both the MDR and the IVDR; its stated aims include more proportionate and predictable conformity assessment, wider use of electronic instructions and digital labelling, one framework for devices using artificial intelligence and a larger coordinating role for the European Medicines Agency. As of September 2026 it has been submitted to the European Parliament and the Council but not adopted, so the present text and the Regulation (EU) 2024/1860 dates apply.
Does Sterling issue certificates or act as a notified body?
No. Sterling builds the quality management system, the performance evaluation, the technical documentation and the post-market processes with you, and prepares your people. The notified body audits, assesses and certifies; the declaration of conformity and the CE mark are then yours to apply. Sterling is not a notified body, an EU reference laboratory, an authorised representative or a testing laboratory.
Before the first call
Prepare a useful EU IVDR readiness brief
No finished technical documentation is needed for a first discussion; a short account of your tests, markets and dates is enough. Seven questions cover it:
- Which devices are involved, what is each one's intended purpose, and which Annex VIII rule and class do you think applies?
- Are you the legal manufacturer, where are you established, and who acts as your authorised representative if you are outside the EU?
- What exists today: an ISO 13485 certificate, Directive 98/79/EC declarations or certificates, performance data, a risk management file?
- Is any device class D, a companion diagnostic, or intended for self-testing or near-patient testing?
- Which notified body, if any, have you applied to, and where does the application stand?
- Who is, or will be, your PRRC, and how are complaints and possible incidents handled now?
- Is there a legacy date, a launch, a tender or a distributor's deadline to plan around?
These answers are the basis for a realistic scope and all-inclusive proposal. Nothing in them is a classification ruling or regulatory advice; that comes from the work itself.
Don’t be fooled by certification scams
If it takes ten days, it is not EU IVDR compliance.
The IVDR issues no certificate of its own, so substitutes are sold instead: "IVDR certificates" and "CE certificates" from organisations absent from NANDO, performance evaluation templates with another manufacturer's assay still in them, and self-declaration packs for tests that are not plain class A. They are cheaper until a notified body or a competent authority reads them.
How to choose a credible EU IVDR provider
- Check the notified body in NANDO. It must be designated under Regulation (EU) 2017/746 with a scope covering your device; no other organisation can issue the certificates your CE mark depends on.
- Find out what an offered certificate really certifies. ISO 13485 certificates come from accredited certification bodies and cover a quality system, not a device; an "IVDR certificate" sold with consulting covers nothing.
- Ask how the performance evaluation will be built, from which of your data, and who judges whether it is sufficient.
- Identify who does what, which costs sit outside the fee, and what support exists when a deficiency letter arrives.
- Ask how your team will be trained and which system will hold the records. A file only the consultant understands leaves when the consultant does.
- Walk away from "CE marked in 10 days", from class A self-declaration offered for a self-test, and from a PRRC who signs without reading. The system has to run, and the evidence has to exist, before a notified body can assess either.
Keep exploring
More on EU IVDR 2017/746 and related standards
More in Healthcare, medical devices & life sciences
Talk to a consultant
Plan your EU IVDR compliance with confidence.
Tell us your goals, locations and target date. We’ll help you define the scope, timeline and next steps.
hello@sterling-grc.com+1 201 263 4443 (global headquarters) · your nearest office and its number are at the top of this page
What would you like to achieve?
Choose a starting point. The enquiry form takes about a minute.
Book my free discovery callContinue to the enquiry form to share your details. Please do not include passwords, sensitive personal information or confidential files. A Sterling consultant replies within one working day. Privacy notice