MDR (Medical Device Regulation) Consulting

Q: Can you work with our existing technical documentation?

Yes. We review current files, identify deficiencies, and upgrade content and structure to Annex II/III expectations.

Q: Do all medical devices require Notified Body involvement?

No. Some Class I devices may follow self-declaration routes, while higher-risk classes require Notified Body conformity assessment.

Q: Do you support MDD to MDR transition programs?

Yes. We support transition strategy, remediation priorities, and execution tracking for legacy portfolios.

Q: Can you support response rounds during Notified Body review?

Yes. We help prepare clarification packages, evidence updates, and corrective action responses.

Q: Can your team align MDR work with ISO 13485 and ISO 14971?

Yes. We align quality and risk outputs with regulatory documentation to reduce review inconsistencies.

Q: Which device classes do you support under MDR?

We support Class I , IIa, IIb, and III devices.

Q: What deliverables should we expect in the first phase?

Typical first-phase outputs include a gap report, risk-ranked action plan, scope definition, and documentation priorities.

Q: Can you support PMS, PMCF, PSUR, and EUDAMED activities?

Yes. We support post-market documentation workflows and role responsibilities linked to ongoing MDR obligations.

Q: Do you provide urgent remediation support before deadlines?

Yes. We can prioritize high-impact gaps and run accelerated remediation plans for time-critical submissions.

Navigate the complexities of Medical Device Regulation (MDR) with confidence. Our consulting services provide end-to-end support, from gap analysis and technica...

EU MDR Consulting Services for Medical Device Manufacturers

Strategic EU MDR Assessment

MDRCert offers a strategic partnership that goes beyond standard consulting to guarantee your market access under the EU Medical Device Regulation (MDR 2017/745). We transform the stringent and complex requirements of the MDR into manageable processes without disrupting your operational efficiency. From comprehensive MDR gap analyses to structuring your Technical Documentation and Clinical Evaluations, we provide end-to-end, solution-oriented approaches tailored specifically for EU MDR compliance.

End-to-End MDR Certification & Surveillance

Our goal is to eliminate all uncertainties during your Notified Body application process for MDR certification. We execute robust strategies covering everything from Annex II/III technical files and GSPR (General Safety and Performance Requirements) alignment to rigorous Post-Market Surveillance (PMS) and PMCF activities. We don't just secure your MDR CE marking; we crown your medical devices with sustained regulatory compliance, ensuring uninterrupted market access and a competitive edge in Europe.

How Our MDR Consulting Engagement Works

Structured support from assessment to certification

Assess

Assessment and Gap Analysis

Plan

Regulatory Strategy and Scope

Build

Technical and Clinical Documentation

Submit

Submission and Notified Body Review

Maintain

Post-Market Compliance and Updates

What manufacturers expect from MDR consulting

Most teams look for the same outcomes: faster CE marking readiness, fewer review delays, and stronger documentation quality.

Our MDR consulting service is built around these priorities with practical support for gap analysis, technical file structure, clinical evaluation, and post-market obligations.

Roadmap

Prioritized actions based on regulatory risk and submission impact.

MDR Roadmap You Can Execute

File

Annex II/III documentation aligned to review expectations and traceability.

Technical File Readiness

Review

Preparation for questions, findings, and response cycles with clear ownership.

Notified Body Preparation

Lifecycle

PMS, PMCF, and update workflows to sustain compliance after certification.

Post-Market Continuity

Need clarity before your next MDR submission?

Core MDR Consulting Coverage

MDRCert Testimonials

Testimonials

Frequently Asked Questions About MDR Consulting

The questions below reflect what manufacturers most often ask before starting an MDR compliance project.

How long does an MDR consulting project usually take?

Timeline depends on device class, documentation maturity, and evidence gaps. After assessment, we provide a phased plan with practical milestones.

Can you work with our existing technical documentation?

Do all medical devices require Notified Body involvement?

Do you support MDD to MDR transition programs?

Can you support response rounds during Notified Body review?

Can your team align MDR work with ISO 13485 and ISO 14971?

Which device classes do you support under MDR?

What deliverables should we expect in the first phase?

Can you support PMS, PMCF, PSUR, and EUDAMED activities?

Do you provide urgent remediation support before 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

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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.

Still have questions?

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