IVD
Your IVD through the IVDR, from classification to post-market.
We guide class A to D through classification, performance evaluation, conformity assessment, EUDAMED registration and ongoing post-market surveillance.
Book an intro call on IVDOverview
The IVDR paradigm shift translated into a workable development reality.
- Risk classes
- A · B · C · D
- EU framework
- IVDR (EU) 2017/746
- QMS
- ISO 13485
- US market access
- FDA 510(k) / PMA
We support manufacturers of in vitro diagnostics across the full lifecycle: from classifying the portfolio under Annex VIII of the In Vitro Diagnostic Regulation (EU) 2017/746, through performance evaluation under Art. 56 and Annex XIII, the QMS under ISO 13485:2016 and the technical documentation, to certification by the notified body, EUDAMED registration and ongoing post-market surveillance. The critical fork is rarely the assessment itself, but notified body availability and clinical performance, which for legacy products is often the largest evidence gap and requires lead time for study planning and ethics committee approval.
For decision-makers
A classification corrected late changes the conformity route, deadlines and evidence needs in one stroke. The extended transition periods only apply with a timely application and a signed agreement with the notified body, and post-market obligations already apply to legacy products during the transition period.
Key regulations & standards
Which standards apply in which phase?
What delays projects is rarely a missing standard, it is the sequence. This is how the requirements interlock across the entire lifecycle.
- 01
Classification
- Class A-D (Annex VIII IVDR)
- Intended purpose & target market
- Risk management (ISO 14971)
- 02
Performance evaluation
- Scientific validity
- Analytical performance (ISO 17511)
- Clinical performance (Annex XIII)
- 03
Regulatory & approval
- Technical documentation (Annex II/III)
- Conformity assessment (Annex IX-XI)
- Notified body (class B-D)
- QMS (ISO 13485)
- 04
Launch
- CE marking
- EUDAMED / UDI
- FDA 510(k) / PMA (in parallel)
- 05
Post-launch
- Post-market surveillance & vigilance
- PMPF (Annex XIII Part B)
- Periodic Safety Update Reports
Industries
What challenges shape IVD?
Reclassification of the entire portfolio under Annex VIII
The IVDR (EU) 2017/746 replaces the self-certification of Directive 98/79/EC with a risk-based system using classes A through D. According to industry estimates, the vast majority of IVDs require a notified body for the first time. The rules in Annex VIII up-classify entire product groups, for example infectious disease diagnostics and companion diagnostics; a class corrected late changes the conformity route, deadlines and evidence requirements all at once.
Clinical performance evidence for classes C and D
The performance evaluation under Art. 56 and Annex XIII rests on three pillars: scientific validity, analytical performance and clinical performance, documented in the Performance Evaluation Report. Many manufacturers have robust analytical data but no clinical performance evidence. Literature alone rarely suffices; in-house performance studies under ISO 20916:2019 need lead time for study planning and ethics committee approval.
Limited notified body capacity
Only a few notified bodies are designated for the IVDR. Certification procedures currently take a long time, and signing the contract early is often the real chokepoint, not the assessment itself. The extended transitional periods under Art. 110, amended by Regulations (EU) 2022/112 and (EU) 2024/1860, apply only under certain conditions, including a timely application and a signed agreement with the notified body.
Companion diagnostics in step with drug development
Companion diagnostics fall into class C under Annex VIII and require consultation of a medicines authority or the EMA within the conformity assessment procedure. Development must be synchronized with the medicinal product's timeline, which calls for coordinated management of performance studies, technical documentation and authority interaction across multiple stakeholders.
Post-market obligations already apply to legacy products
Under Art. 110(3), the IVDR requirements for post-market surveillance, vigilance and registration already apply during the transitional period for legacy products, not only once the new certificate is issued. These include the PMS plan and PSUR under Art. 78 to 81, the reporting system under Art. 82 et seq. as well as registration in EUDAMED with UDI marking. The gap surfaces at the latest during the notified body audit.
The real break with the IVDR is not the new products, but rather the existing portfolio. Reclassification under Annex VIII suddenly requires performance evidence and a notified body for products that were self-certified for years, and that evidence cannot be built retroactively, it has to be planned in from the start.
Dr. Jennifer Neff · Vice President Medical Device
Why Entourage
What sets us apart from classic consultancies and freelancers.
- Industry focus100% life sciences
- Deliveryoperational, on site
- Regulatory depthGxP, FDA, EMA, MDR/IVDR
- Flexibilityproject or framework contract
- Industry focuscross-industry
- Deliverymostly strategic
- Regulatory depthgeneralist
- Flexibilitylong contract terms
- Industry focussingle niche
- Deliverysingle person
- Regulatory depthown niche
- Flexibilityday rate
Expertise
Our expertise for IVD
Next step
Where does your project stand regulatorily?
Use our free readiness checks for a first assessment, or talk to an expert directly, without obligation.
- 100% life sciences
- 500+ projects completed
- Reply usually within one working day
Contact
Your contacts for IVD
Dr. Jennifer Neff
Vice President Medical Device
Strategic lead for the medical device division, advising on MDR compliance, clinical evaluation and conformity obligations.
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Dr. Julia Beck
Head of Sales MedTec
Responsible for client relationships and the sale of tailored consulting solutions in the MedTech and IVD space.
Get in touch →FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/746 (IVDR), primary text, Art. 5, 10, 56, 78-82, 110, Annex I, II, III, VIII, XIII
- Regulation (EU) 2022/112, amendment to the IVDR transitional provisions
- Regulation (EU) 2024/1860, staggered extension of the transitional periods and EUDAMED rollout
- Directive 98/79/EC (IVDD)
- ISO 13485:2016, ISO 14971:2019, ISO 20916:2019, IEC 62304
- Widget of the existing industry page: entourage-website-writer/output/industry-pages/ivd/ivd-widget.html
- https://theentourage.de/branchen/ (industry hub, live content)
Industries
More industries
Pharma
Hands-on support across the entire lifecycle, from drug substance research to GDP-compliant distribution. On the ground, from the shop floor to the authority dossier.
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Biotech
From biomedical research to industrial GMP manufacturing: scale-up from lab scale to commercial production of biologics, with complete process characterization and CMC documentation.
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MedTech
From product development to post-market surveillance: the EU MDR translated pragmatically into day-to-day development, for a time-critical, audit-ready market access.
Learn more →Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +49 89 4161170-0
info@theentourage.de
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences