IVDR Consultants for Regulation (EU) 2017/746

At RAPS, IVDR compliance is more than a service — it’s our specialty.

We provide expert consulting for all classes of in vitro diagnostic (IVD) devices, supporting manufacturers at every stage of their regulatory journey under the In Vitro Diagnostic Regulation (IVDR) 2017/746. Our team has extensive experience developing fully compliant:

Technical Documentation
Performance Evaluation Reports (PERs)
Risk Management Plans
Post-Market Surveillance (PMS) Strategies

Having previously supported numerous clients with IVDD (93/42/EEC) compliance, we understand the shift in regulatory expectations and are well-positioned to help your organization transition smoothly and successfully to the IVDR framework.

Are You IVDR-Ready?

The new regulation places increased emphasis on:

Clinical data and scientific validity
Comprehensive performance evaluation
Ongoing post-market surveillance and vigilance
Alignment with General Safety and Performance Requirements (GSPRs)

If your existing documentation was built for IVDD, it’s time for a critical review. The IVDR demands a higher standard of evidence and documentation — particularly in areas like clinical performance, PER completeness, and PMS execution.

Why Choose RAPS?

In-depth knowledge of IVDR requirements
Proven track record with EU notified bodies
End-to-end support, from classification to CE marking
Specialists in PER development and PMS compliance

Ensure your IVD products meet the latest EU regulatory standards with confidence.
Partner with RAPS — your trusted IVDR consulting experts.

★ Let’s Talk Compliance – Contact us today to schedule a free consultation.

Responsibilities of IVDR Consultants

Complying with the In Vitro Diagnostic Regulation (IVDR) 2017/746 requires more than regulatory awareness — it demands specialized expertise. As experienced IVDR consultants, RAPS offers the deep regulatory insight and technical know-how needed to navigate the complexities of IVDR and secure market access within the EU.

Since the regulation’s full application in May 2022, manufacturers are under pressure to meet heightened requirements in performance evaluation, risk management, documentation, and post-market activities. This is where we come in.

Key Responsibilities of RAPS IVDR Consultants

Our team provides end-to-end regulatory support, including:

Due Diligence & Classification
- Confirming device classification based on IVDR risk rules
- Gap analysis of legacy documentation
Technical Documentation Development
- Preparation and structure of the complete IVDR Technical File
- Verification of intended use, design files, and risk management processes
Performance Evaluation & Scientific Validity
- Design and development of Performance Evaluation Reports (PER)
- Analytical performance planning and scientific validity assessments
Post-Market Surveillance & PMPF
- Creation and maintenance of Post-Market Surveillance (PMS) plans
- Support for Post-Market Performance Follow-up (PMPF) documentation
GSPR Alignment & Compliance
- Mapping of General Safety and Performance Requirements (Annex I)
- Validation of all verification and validation (V&V) reports
Notified Body Interaction
- Submission management, response to technical review queries, and documentation updates

Built on Quality, Driven by Results

Our consulting operations are underpinned by robust standards:

ISO 13485 – Certified Quality Management System
ISO 27001 – Certified Information Security Management
24-hour Response Time – Prompt and reliable communication on technical inquiries

At RAPS, we not only meet the standard — we exceed it, ensuring that your IVD devices are always inspection-ready and fully compliant.

Your Global IVDR Partner

Whether you're based in Europe or anywhere across the globe, our consultants are equipped to handle any IVDR risk class, supporting you from strategy through certification.

Struggling with IVDR transition?
Don’t worry — RAPS has you covered.

Let’s build your compliance strategy together.

★ Contact us now to get started with our expert IVDR consulting team.

Ready to Simplify Your IVDR Journey?

With RAPS by your side, navigating IVDR compliance is straightforward and stress-free.

Expert guidance, timely support, and proven results — all tailored to keep your IVD products market-ready.

Partner with RAPS today and turn IVDR challenges into your competitive advantage.

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.