IVDR (In Vitro Diagnostic Regulation) Consulting

Simplify IVDR compliance with our expert consulting services. We guide you through the entire process, from gap analysis and performance evaluation to technical...

IVDR (In Vitro Diagnostic Regulation) Consulting Services

Plan Your CE-IVD Path with IVDR Confidence

We help IVD manufacturers define the right IVDR route by clarifying classification, intended purpose, and conformity assessment requirements from day one.

Performance Evidence and Technical Documentation Built for Review

From Annex II and Annex III technical documentation to performance evaluation, Notified Body response cycles, and post-market obligations, we build practical IVDR systems that hold under assessment.

Our IVDR Consulting Process

A structured path from strategy to certification

01 - Assess

Classification, Intended Purpose, and Gap Assessment

02 - Plan

Regulatory Strategy and Conformity Route

03 - Build

Performance Evaluation and Technical Documentation

04 - Submit

Notified Body Submission and Deficiency Response

05 - Maintain

PMS, PMPF, SSP, and Ongoing IVDR Governance

What IVD Manufacturers Need Before IVDR Submission

Most teams need the same outcomes: a clear class-based pathway, stronger performance evidence, and fewer delays during Notified Body review.

Our IVDR consulting model is structured around these priorities with practical support across regulatory strategy, technical documentation, and post-market planning.

Clarity
Risk-ranked priorities so your team focuses first on requirements with the highest impact on certification timelines.

Regulatory Clarity

Quality
Annex II/III structures with evidence traceability across scientific validity, analytical performance, and clinical performance.

Documentation Quality That Holds Under Review

Readiness
Preparation for Notified Body questions, findings, and corrective actions through controlled response workflows.

Notified Body Readiness

Continuity
PMS, PMPF, SSP, PMSR/PSUR, and update governance designed for sustained IVDR compliance after certification.

Lifecycle Compliance

Planning an IVDR submission in the next 3-12 months?

Core IVDR Consulting Coverage Areas

Classification and Conformity Assessment Route

Define the right pathway by IVD class and intended purpose to reduce early strategic risk.

Annex II and Annex III Technical Documentation

Build documentation structures that are complete, traceable, and audit-ready for efficient review cycles.

GSPR and Common Specifications Mapping

Map evidence to GSPRs and applicable common specifications with clear rationale and visible gaps.

Performance Evaluation (Scientific, Analytical, Clinical)

Develop coherent evidence logic across performance pillars to support safety, performance, and intended claims.

Risk Management and Usability Alignment

Align risk outputs with labeling, IFU, and performance documentation for consistent reviewer logic.

QMS and Audit Readiness (ISO 13485)

Improve quality system maturity and prepare teams for audits, surveillance, and assessment events.

Notified Body Interaction and Deficiency Response

Prepare structured response packages for findings, clarifications, and corrective actions.

PMS, PMPF, SSP, UDI, and EUDAMED Readiness

Set up practical post-market workflows and data governance to sustain compliance after certification.
MDRCert Testimonials

Testimonials

Medical Device Regulatory Consulting & Compliance | MDRcert

Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...

Medical Device Regulatory Consulting & Compliance | MDRcert

Dr. James Rodriguez

A Global Therapeutic Implant Company
Medical Device Regulatory Consulting & Compliance | MDRcert

MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...

Medical Device Regulatory Consulting & Compliance | MDRcert

Sarah David

A High-Risk Surgical Device Startup
Medical Device Regulatory Consulting & Compliance | MDRcert

As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...

Medical Device Regulatory Consulting & Compliance | MDRcert

Ben Smith

A New MedTech Innovator
Medical Device Regulatory Consulting & Compliance | MDRcert

The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...

Medical Device Regulatory Consulting & Compliance | MDRcert

Thomas Wright

An Established Medical Software Company
Medical Device Regulatory Consulting & Compliance | MDRcert

Implementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn&#...

Medical Device Regulatory Consulting & Compliance | MDRcert

Maria Rodriguez

A Digital Health Platform Company
Medical Device Regulatory Consulting & Compliance | MDRcert

MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...

Medical Device Regulatory Consulting & Compliance | MDRcert

David Chen

A Surgical Device Startup
Medical Device Regulatory Consulting & Compliance | MDRcert

We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...

Medical Device Regulatory Consulting & Compliance | MDRcert

Sarah Jenkins

A European Diagnostic Device Manufacturer

Frequently Asked Questions About IVDR Consulting

These are the most common questions we hear from IVD manufacturers preparing IVDR submissions and transition programs.

How long does an IVDR consulting project usually take?

Can you work with our existing IVDD/IVDR documentation?

Do all IVDs require Notified Body involvement under IVDR?

Do you support IVDD to IVDR transition programs?

Can you support us during Notified Body review rounds?

Can IVDR work be aligned with ISO 13485 and risk management in one program?

Which IVD classes do you support under IVDR?

What should we expect as first-phase deliverables?

Can you support PMS, PMPF, SSP, and EUDAMED activities?

Do you provide urgent remediation support before key deadlines?

Need a clear path to compliance? Talk to MDRCert

Tell us about your device, target market, and current stage. We will guide you on the most practical next steps.

MDRCert Regulatory Support Team

+382 68 682 766

Have questions? Contact our team

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How soon can we get started on your project?

After a short discovery call, we define scope, timeline and deliverables. Most projects begin with a focused gap assessment and action plan.

Can you support only part of our project?

Yes. We can support specific tasks such as technical documentation, CER/CEP, PMS/PMCF, ISO 13485 updates, risk files, or Notified Body responses.

Do you support both new and legacy devices?

Yes. We support first-time EU submissions and legacy transitions under MDR/IVDR, including remediation of existing files and post market obligations.
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