IVDR Compliance and Technical Documentation Support – RAPS

The In Vitro Diagnostic Regulation (IVDR) EU 2017/746, which officially replaced the In Vitro Diagnostic Directive (IVDD), came into full effect on May 26, 2022. As outlined in Article 10(4), all manufacturers seeking CE marking under IVDR must submit a comprehensive Technical File to a designated notified body. This is a critical step for ensuring compliance and market access in the European Union.

At RAPS, we guide manufacturers through every step of the IVDR transition and implementation process, from initial planning to post-market surveillance.

Key Changes Introduced by IVDR

New Risk-Based Classification System: Devices are now classified under strict rules, impacting conformity assessment procedures.
Stronger Clinical Evidence Requirements: Enhanced focus on clinical performance data and continuous performance evaluation.
Unique Device Identification (UDI): Mandatory for improved device traceability throughout the supply chain.
Regulatory Accountability: Designation of a Person Responsible for Regulatory Compliance (PRRC) is now required.
Expanded Scope and Stricter Oversight: All in vitro diagnostic devices, including Class A non-sterile products, are now regulated under IVDR.

Our IVDR Compliance Strategy

1. Device Identification & Project Planning
We begin with a thorough GAP analysis to determine what updates are required for IVDR compliance. Our team then builds a project management framework that includes coordination with subject matter experts, consultants, and your selected notified body.

2. Technical Documentation Development
We assist in conducting robust performance evaluations, creating comprehensive reports, and transferring relevant data into the technical documentation. Our consultants assess your facility to ensure full implementation of a Quality Management System (QMS). We emphasize getting expert input on study design to maintain performance integrity — especially sensitivity and specificity.

3. Notified Body Submission & Review
Once your documentation is complete, we support the submission to your notified body, manage communication, and provide prompt responses to review comments.

4. Post-Market Surveillance & Continuous Evaluation
Compliance doesn’t end at product launch. IVDR mandates ongoing Post-Market Performance Follow-Up (PMPF). We help you design and implement a strategy that gathers real-world clinical evidence throughout the device's lifecycle.

5. EU Representation
For manufacturers outside of Europe, we coordinate with trusted European Authorized Representatives to ensure seamless market entry and regulatory alignment.

Partner with RAPS to ensure your diagnostic devices meet the rigorous demands of IVDR, from documentation to post-market responsibilities. Our experienced regulatory experts are here to guide you every step of the way.

Defining an IVD Device Under the New IVDR Framework

Under the European Union In Vitro Diagnostic Regulation (EU IVDR 2017/746), an in vitro diagnostic (IVD) medical device is broadly defined to encompass a wide range of components and technologies. These include:

Reagents and reagent products
Calibrators and control materials
Kits and instruments
Apparatus, equipment, software, or complete systems

Whether used individually or in combination, these devices must be intended by the manufacturer for the in vitro analysis of specimens derived from the human body—such as blood, tissue, or other biological samples.

Purpose of IVD Devices Under IVDR

According to the regulation, IVD devices must be designed to generate information related to:

The detection or monitoring of physiological or pathological processes or conditions
The identification of congenital physical or mental impairments
The assessment of genetic predisposition to specific medical conditions or diseases
The evaluation of compatibility and safety for potential recipients of treatments or transplants
The prediction of treatment outcomes, responses, or adverse reactions
The guidance or supervision of therapeutic interventions

IVDR Transition Timeline Update

In January 2024, the European Commission proposed an amendment to Regulation (EU) 2017/746 (IVDR), aimed at extending the transition periods for certain in vitro diagnostic devices. The main driver behind this proposal is the limited availability of designated notified bodies, which continues to create bottlenecks in the conformity assessment process.

While the original application date of May 26, 2022, remains unchanged, these extended timelines offer critical relief to both manufacturers and notified bodies. The goal is to maintain patient safety and market stability, ensuring that compliant, high-quality IVD products remain available without being withdrawn prematurely due to regulatory constraints.

At RAPS, we help ensure that your devices are accurately classified and fully compliant with the scope and intent of the IVDR definition. Our expert team provides the strategic and regulatory support needed to meet all essential requirements from concept to certification.

Extended Transition Deadlines for IVD Devices: What Manufact

The In Vitro Diagnostic Regulation (IVDR) – EU 2017/746 introduced transformative changes to the regulatory framework governing IVDs in the European Union. In response to industry-wide challenges in meeting these new requirements, the European Commission has implemented extended transition timelines to support a more practical and sustainable path to compliance.

Why Were Timelines Extended?

Although the IVDR officially replaced the IVDD and became applicable on May 26, 2022, an amendment was introduced to provide more time for compliance—particularly for life-saving and essential diagnostic devices. The rationale was clear:

Insufficient readiness across key stakeholders: manufacturers, notified bodies, and even healthcare providers.
Limited capacity of notified bodies to handle the sharp increase in conformity assessments.
The risk of market shortages if compliant devices could not be certified in time.

As a result, Regulation (EU) 2024/1860, published on July 9, 2024, formally extends transition periods for eligible legacy IVDs. Additionally, Regulation (EU) 2023/607 removed the ‘sell-off’ provision, meaning that IVDs already placed on the market can now remain available or in service until their certificate expires or shelf life ends, without forced withdrawal.

Key Updates Manufacturers Should Know

The revised transition timelines depend on the risk classification of the IVD and whether it was previously certified under the IVDD or self-declared. Highlights include:

☆ Legacy Devices:

Applies to IVDs that were:

Certified under Annex II List A, List B, or as self-tests under the IVDD.
Placed on the market between May 25, 2017, and May 25, 2022.
Not withdrawn by the manufacturer or expired.

To benefit from the extended deadlines, manufacturers must now meet specific conditions, including:

No significant design or intended-use changes.
Ongoing compliance with IVDD requirements.
Implementation of a Quality Management System (QMS) aligned with IVDR.
Engagement with a notified body under the IVDR framework.

RAPS Guidance on IVDR Transition

At RAPS, we provide strategic and technical support to:

Assess eligibility for transition extensions.
Align legacy products with current IVDR expectations.
Navigate notified body interactions and prepare robust technical documentation.
Ensure continued market access and patient safety.

Need help navigating the latest IVDR extensions? Contact our regulatory experts today to develop a tailored transition plan and avoid disruptions to your product pipeline. RAPS is right here to help you.