Specialized Services EU MDR and IVDR Compliance Services

Master the complexities of European medical device regulations with comprehensive compliance strategies that ensure market access while managing the transition from MDD to MDR.

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Transition into full EU MDR compliance alongside regulatory experts

The EU Medical Device Regulation (MDR) represents the most significant change in European device legislation in decades. With increased clinical evidence requirements, enhanced post-market surveillance, and stricter supply chain controls, MDR compliance demands fundamental changes to quality systems, technical documentation, and business processes.

Deadlines have passed for many devices, but challenges remain. Legacy devices need updated documentation. New classifications require different conformity routes. Economic operators face expanded responsibilities. The regulation's complexity—combined with notified body backlogs—creates risks for market access and business continuity.

Our EU MDR specialists combine regulatory expertise with practical implementation experience. We've guided hundreds of devices through MDR transition, understanding both what the regulation requires and how to achieve compliance efficiently.



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Our EU MDR compliance services include:

  • Gap assessment against MDR and IVDR requirements

  • Device classification and regulatory strategy development

  • Technical documentation (TD) creation and remediation

  • Clinical evaluation planning and report authoring (CERs, PERs)

  • Post-market surveillance (PMS) system design

  • Post-market clinical follow-up (PMCF) planning and execution

  • Unique Device Identification (UDI) system setup and EUDAMED registration

  • Appointment and support for Person Responsible for Regulatory Compliance (PRRC)

  • Economic operator agreements and role definition

  • Notified body submission preparation and response support

  • Quality system alignment with EN ISO 13485 and MDR/IVDR requirements

  • Vigilance and trend analysis process development

  • Supplier and subcontractor compliance oversight

Key MDR challenges we address include but are not limited to:

  • Article 120 transition strategies
  • Clinical evidence requirements
  • Technical documentation updates
  • Biological safety evaluation
  • Software qualification and classification
  • Custom-made device procedures
  • Substance-based devices
  • Legacy device remediation

Click to expand How we help you navigate EU MDR & IVDR compliance

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We structure our support around three core domains—Assessment & Planning, Implementation & Submission, and Post-Market & Sustainability—so manufacturers can move from transition to compliance to continuous alignment with regulatory evolution.

  • Assessment & Planning

    • Gap assessment & baseline review: Evaluate current QMS, technical documentation, and regulatory procedures against MDR/IVDR expectations.

    • Transition roadmap & resource planning: Develop a prioritized plan for Article 120 transition, technical file remediation, and notified body submission scheduling.

    • Portfolio and classification review: Rationalize device portfolios, confirm classifications, and select appropriate conformity routes.

    • Governance and training setup: Define roles (including PRRC), establish cross-functional working groups, and develop organization-wide training programs.

  • Implementation & Submission Support

    • Technical documentation (TD) development: Create or remediate technical files to meet MDR Annex II & III or IVDR Annex II standards, incorporating GSPR, clinical, and risk data.

    • Clinical evaluation & PMCF planning: Prepare compliant CERs/PERs and post-market clinical follow-up plans aligned to MEDDEV 2.7/1 Rev. 4 and MDCG guidance.

    • Post-market surveillance & vigilance: Design PMS plans, PSURs, vigilance reporting, and trending mechanisms to ensure continuous compliance.

    • UDI & economic operator systems: Implement compliant labeling, registration, and data exchange processes across distributors and importers.

    • Notified body support: Prepare submission packages, manage review cycles, and coordinate audit preparation.

  • Post-Market & Sustainability

    • Legacy device remediation: Manage ongoing maintenance and re-certification of legacy devices through MDR transition periods.

    • Regulatory intelligence: Monitor MDR/IVDR updates, MDCG guidance, and emerging common specifications.

    • Ongoing compliance systems: Integrate CAPA, trending, and change control processes tied to PMS and vigilance data.

    • Re-audit and renewal support: Coordinate future notified body audits, renewals, and conformity assessments.

    • Continuous improvement: Embed feedback loops to sustain compliance as guidance and interpretations evolve.

  • Device Types & Scope Covered

    • Legacy MDD devices transitioning to MDR

    • New devices entering MDR or IVDR frameworks

    • In vitro diagnostics (IVDs) under IVDR

    • Accessories and software/SaMD products

    • Custom-made and reusable surgical devices

    • Substance-based and combination products

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Why manufacturers choose The FDA Group for MDR and IVDR transition

  • Comprehensive expertise: In-depth understanding of MDR and IVDR frameworks, Annex structures, and notified body expectations.

  • Proven experience: Track record guiding hundreds of successful transitions across device types and risk classes.

  • Strategic guidance: Practical, risk-based plans that align compliance with business priorities.

  • Global coordination: Integrated support aligning EU requirements with FDA and other international regulatory systems.

  • Regulatory relationships: Experienced in managing notified body communications and accelerating review outcomes.

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific EU MDR compliance needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.