Language
Branch
Start Your Career
Regulatory & Compliance

IVDR Readiness.

IVDR Readiness refers to the structured preparation of an in vitro diagnostic medical device for conformity assessment under EU Regulation 2017/746 —from classification and the performance evaluation plan through to EUDAMED registration. Class C manufacturers must submit their application to the Notified Body by May 26, 2026.

In vitro diagnostics in the laboratory

What is IVDR Readiness? IVDR Readiness refers to the systematic preparation of IVD manufacturers for EU Regulation 2017/746 (IVDR). It encompasses classification, performance evaluation, technical documentation, and collaboration with Notified Bodies—with the aim of ensuring long-term market access for in vitro diagnostic medical devices in the EU.

Will you still be able to meet the Class C deadline in May 2026?

The IVDR now requires the involvement of a Notified Body for nearly 80% of all IVDs (which were previously self-certified). The waiting lists are long, and the deadlines are strict. Those who do not prepare systematically now risk being excluded from the market:

  • Classification according to Annex VIII. Which of the classes A through D applies to your IVD? Every misclassification costs valuable months with the Notified Body.
  • Performance Evaluation Plan. How do you structure your Performance Evaluation Plan (PEP) and Report (PER) in strict accordance with the requirements of MDCG 2022-2?
  • Notified Body capacities. Which of the few Notified Bodies designated for the IVDR will still have audit capacity available for your specific product category in 2026?
We offer support for conformity assessment with a focus on deadline awareness—practical deadline management rather than purely theoretical advice.
Quality control of in vitro diagnostic devices

Our IVDR services.

We develop a clear transition strategy for your entire IVD portfolio and minimize the number of iterations with Notified Bodies by preparing methodologically sound dossiers.

IVD Classification & Bridging Strategy
Mandatory classification in accordance with Annex VIII (Classes A through D) and the development of an effective bridging strategy for the transition from the old IVDD to the IVDR.
Performance Evaluation (PEP & PER)
Development of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER), including scientific validity, analytical performance, and clinical performance.
Structured Dialogue with Notified Bodies
Facilitation of "Structured Dialogues" and submission to Notified Bodies (BSI, TÜV SÜD, DEKRA, etc.) to secure audit slots before critical deadlines.
Technical Documentation & GSPR
Preparation of complete technical documentation in accordance with Annexes II and III of the IVDR, including precise mapping of the General Safety and Performance Requirements (GSPR) as set forth in Annex I.

Regulatory updates in video format.

Entourage Regulatory Briefings

Don’t miss any deadlines or regulatory changes. In our regular video updates, our experts provide practical summaries of the most important developments related to the IVDR and MDR.

Free White Paper

Software as a Medical Device & AI Act

Find out why the intended use under the IVDR almost automatically classifies your software as "high-risk AI" under the AI Act—and what implications this has for your QMS.

Download the white paper for free →

What is the process for an IVDR project with ENTOURAGE?

From classification to certification—a structured 5-step process.

01

Classification

IVDR classification according to Annex VIII. Determine the risk class and establish the conformity assessment route.

02

Gap Analysis

Technical documentation, performance evaluation, and verification of the QMS against the IVDR.

03

Documentation

Create or update PER, SSCP, and labeling.

04

NB Coordination

Select a notified body, coordinate audit dates, and submit documentation.

05

Certificate

Support during the certification audit. Follow-up on outstanding findings.

Attorney at Law
"The IVDR is not simply a variation of the MDR—it has its own classification rules, its own performance requirements, and its own deadlines. Anyone who applies their MDR experience directly will overlook critical differences."
Regulatory Affairs Team, ENTOURAGE

Frequently Asked Questions About the IVDR.

How does the IVDR classification differ from the old IVDD?
Under the old IVD Directive (IVDD), approximately 80% of in vitro diagnostic devices could be certified by the manufacturers themselves. The new IVDR uses a rule-based classification system (Classes A through D). As a result, nearly 80% of all IVDs now require a conformity assessment by a Notified Body.
What is the difference between PEP and PER?
The Performance Evaluation Plan (PEP) outlines, in advance, the methodology for demonstrating the performance of the IVD. The Performance Evaluation Report (PER) is the final document that summarizes and evaluates the collected data (scientific validity, analytical and clinical performance).
Which notified bodies are currently designated under the IVDR?
Currently (as of mid-2026), there are only a very limited number of designated Notified Bodies for the IVDR (fewer than 15 across Europe), including BSI, TÜV SÜD, DEKRA, and MDC. This is leading to severe bottlenecks in audit capacity.
By when must I submit my application (Class C / B / A sterile)?
For existing Class D "legacy devices," the deadline was May 2025. For Class C devices, the formal application must be submitted by May 26, 2026, and a contract with the Notified Body must be signed by September 2026. Class B and A (sterile) devices will follow in May 2027.
What happens if I miss the deadline?
If you miss the application deadline for your specific risk class and cannot provide a signed agreement with a Notified Body, your product will lose its marketability. You will no longer be permitted to place it on the market in the EU until the complete IVDR certificate is available.
Does the IVDR also apply to in-house IVDs manufactured by the company itself?
Yes. Since May 26, 2024, in-house IVDs (In-House-IVDs) have also been subject to the IVDR requirements under Article 5(5). Healthcare facilities must demonstrate that no equivalent CE-marked IVD is available.
How much does IVDR compliance cost?
The effort required depends on the product portfolio and risk class. For a single Class C product, you should expect 15–30 consultant days. Complex portfolios containing Class D products require significantly more resources.

Additional regulatory expertise.

Expertise

MDR Consulting

Clinical evaluation and post-market surveillance for your medical device.

 Expertise

EUDAMED Registration

Secure registration of your UDI data in the European database.

 Expertise

EU AI Act

Single Conformity Assessment for IVD software with AI components.

Conformity assessment with a notified body that stays on schedule.

Don’t miss any deadlines. We ensure that your technical documentation and performance evaluation report are methodologically sound and are efficiently approved by the Notified Body.

Submit a project inquiry.

Please briefly describe your current challenge. An expert from our team will contact you shortly.