IVDR Technical Documentation: A Core Compliance Requirement

Technical documentation is a cornerstone of compliance under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). It encompasses the complete set of evidence demonstrating that your IVD medical device meets all applicable regulatory requirements — and must be maintained throughout the entire product lifecycle.

Whether you're introducing a new IVD device or transitioning a legacy product, keeping your technical file up to date is not just good practice — it’s mandatory under IVDR.

What Does IVDR Technical Documentation Include?

Depending on the device classification and the conformity assessment route, your Notified Body may be required to review all or parts of your documentation. Key regulatory references include:

Annex II and Annex III of the IVDR: Outline the specific structure and content of the technical documentation required.
Article 11(3): Requires manufacturers to ensure that a full copy of the technical documentation is always available to the European Authorized Representative (EAR).
Article 15(3): States that a Person Responsible for Regulatory Compliance (PRRC) must be available at the manufacturer’s location to manage regulatory obligations.
Annex IX, Chapter II: Emphasizes the requirement for ongoing updates to technical files, particularly post-notified body certification.

Our Support at RAPS

At RAPS, we provide expert assistance with:

Compiling, reviewing, and structuring technical documentation in alignment with IVDR Annex II & III
Ensuring documentation is audit-ready and accessible to notified bodies and competent authorities at any time
Supporting your PRRC and EU Authorised Representative with up-to-date files for compliance and inspection
Coordinating updates after clinical performance studies, design changes, or post-market surveillance findings

Stay ready. Stay compliant.
Let RAPS help you manage your technical documentation lifecycle and maintain full regulatory readiness — from submission to surveillance.

IVDR Technical Documentation Requirements

Under Regulation (EU) 2017/746 (IVDR), technical documentation is a mandatory requirement for all in vitro diagnostic (IVD) medical devices, regardless of classification or risk level. Outlined in Annex II and Annex III, these documentation standards form the foundation for demonstrating regulatory compliance and securing CE certification with a notified body.

At RAPS, we help you compile, organize, and maintain your IVDR technical file in full alignment with the structure prescribed by the Global Harmonization Task Force’s (GHTF) STED format — ensuring audit readiness and regulatory approval.

Key Elements of Technical Documentation

As outlined in Annex II, the IVDR Technical Documentation must include the following six core chapters:

1. Device Description and Specifications

Device overview, intended purpose, and indications for use
Variants, configurations, and accessories

2. Information Supplied by the Manufacturer

Labels, Instructions for Use (IFU), and packaging details
Any marketing materials relevant to safe and effective use

3. Design and Manufacturing Information

Full traceability of design and development processes
Manufacturing procedures, suppliers, and quality controls

4. General Safety and Performance Requirements (GSPRs)

Evidence of compliance with all applicable GSPRs
Referenced standards and conformity routes

5. Benefit-Risk Analysis and Risk Management

Risk management reports based on ISO 14971
Clinical justification for benefit-risk conclusions

6. Product Verification and Validation

Analytical and clinical performance studies
Scientific validity, stability, and usability data
Validation of software, sterilization, shelf life, and packaging (where applicable)

Post-Market Requirements – Annex III

Manufacturers must also maintain a Post-Market Surveillance (PMS) strategy in accordance with Annex III, which includes:

PMS Reports (PMSR) – Required for Class A and B devices
Periodic Safety Update Reports (PSUR) – Required for Class C and D devices
Post-Market Performance Follow-Up (PMPF) activities
A fully operational vigilance system

Essential Considerations

Article 10(4) of the IVDR mandates the creation and maintenance of a Technical File for every IVD device seeking CE marking.
A Person Responsible for Regulatory Compliance (PRRC) and your EU Authorized Representative (EAR) must always have access to the final, updated documentation.
Preparing the IVDR technical file is a universal requirement, regardless of the device's classification or whether a notified body is involved.

How RAPS Can Help

At RAPS, our team of regulatory specialists and CE-marking consultants assist you in:

Assembling technical documentation according to Annex II & III requirements
Fulfilling PMS and PMPF obligations across the device lifecycle
Preparing your organization for notified body reviews, audits, and EU market entry

Future-proof your IVD compliance.
Connect with RAPS to ensure your technical documentation meets every IVDR requirement — accurately, efficiently, and on time.

IVDR Technical Documentation and GSPR Compliance

Under the In Vitro Diagnostic Regulation (EU) 2017/746, all manufacturers must demonstrate that their IVD devices comply with the General Safety and Performance Requirements (GSPRs) outlined in Annex I of the regulation. This is done through a detailed and comprehensive technical documentation file — including the Performance Evaluation Report (PER) — that clearly evidences conformity across all relevant requirements.

At RAPS, we support you in aligning every aspect of your documentation with the GSPRs to meet notified body expectations and ensure smooth market access.

What Are GSPRs?

SPRs form the regulatory foundation of the IVDR. They establish the criteria for safety, performance, design, and risk management across the entire lifecycle of an IVD device.

Key elements include:

Performance requirements: Analytical, clinical, and scientific validity
Design & manufacturing controls
Risk-benefit justification
Labeling and instructions for use (IFU)
Biocompatibility and usability
Software validation and cybersecurity (if applicable)

Manufacturers may demonstrate compliance using applicable European harmonized standards. These standards help simplify conformity by aligning with recognized technical benchmarks.

Risk Management and Lifecycle Approach

According to Annex I, Section 3, IVDR requires that risk management is a continuous process — extending beyond development into manufacturing, market surveillance, and post-market corrective action. Documentation must be routinely updated to reflect new data, complaints, incidents, or regulatory developments.

Post-Market Surveillance (PMS) and PMPF Requirements

The PMS plan, outlined in Annex III, must detail how manufacturers monitor real-world performance and safety. It must include data from:

Serious incidents
User complaints
Scientific literature
Public sources and reports from similar devices

A crucial element of PMS is the Post-Market Performance Follow-Up (PMPF) plan, which must align with the results of your risk analysis and clinical evidence. It helps confirm continued performance, detect emerging risks, and validate intended use.

PMSR and PSUR Reporting Obligations

Depending on the device classification, manufacturers must submit the following:

☆ Class A and B

PMS Report (PMSR) based on market surveillance activities
Must be maintained and updated regularly

☆ Class C and D

Periodic Safety Update Report (PSUR) required for each device
Must be updated at least annually
Submitted initially with the technical documentation and subsequently upon request by the Notified Body

Performance Evaluation Report (PER)

As required by Annex XIII, a Performance Evaluation Report (PER) must be submitted as part of the IVDR technical documentation. It integrates:

Scientific validity
Analytical performance
Clinical performance

The PER is critical in justifying the intended use and benefit-risk ratio of the device — and is reviewed in detail during the conformity assessment process.

RAPS: Your IVDR Compliance Partner

At RAPS, we offer tailored support for:

Mapping GSPR requirements to your device design and claims
Preparing and updating PMS, PMPF, and PSUR/PMSR reports
Developing high-quality, evidence-backed Performance Evaluation Reports
Ensuring full alignment with Annex I, III, and XIII documentation expectations

Meet the GSPRs with confidence.
Partner with RAPS to develop robust technical documentation that secures CE marking and supports long-term compliance under IVDR.

Ready for IVDR Success?

Navigating the IVDR isn’t just about meeting deadlines — it’s about building a strong foundation for long-term regulatory compliance, patient safety, and market success.

At RAPS, we guide manufacturers through every stage of IVDR compliance — from classification and technical documentation to performance evaluation, notified body interactions, and post-market surveillance.

Let’s make your IVD device IVDR-ready — efficiently, accurately, and confidently.

Expert Guidance
End-to-End Compliance Support
Peace of Mind in a Changing Regulatory Landscape

Contact us today to start your IVDR journey with RAPS.