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Regulatory & Compliance

MDR Consulting.

We ensure the safe launch of your medical devices on the European market—from the initial gap analysis and technical documentation through to successful certification by the Notified Body.

Engineers discuss regulatory approval stages at the blueprint

What is MDR Consulting? MDR Consulting provides regulatory consulting services to medical device manufacturers to help them comply with EU Regulation 2017/745 (Medical Device Regulation). Our services include gap analyses, preparation of technical documentation, preparation for Notified Body audits, and post-market surveillance—all with the goal of securing CE marking and market access.

What challenges does the MDR pose for medical device manufacturers?

The Medical Device Regulation (EU) 2017/745 presents manufacturers of Class I through III devices with unprecedented regulatory hurdles:

  • The safety and performance requirements (GSPR) are significantly stricter than those of the old MDD.
  • The requirements for technical documentation and clinical evaluation have been significantly expanded.
  • The requirement for Unique Device Identification (UDI) and registration in EUDAMED ties up valuable resources.
  • Systematic post-market surveillance (MDR Articles 83–86) requires entirely new, proactive processes within the company.
Are you sure your technical documentation would pass an audit by the Notified Body today?
Regulatory specialist reviews MDR compliance checklists

Our solutions for your MDR compliance.

We guide you step by step through the MDR approval process and help you avoid costly project delays.

Regulatory Gap Analysis
Identification of critical compliance gaps regarding MDR requirements. We develop a clear roadmap for your entire product portfolio to be coordinated with the Notified Body.
Technical Documentation & UDI
Creation, maintenance, and management of MDR-compliant technical documentation in accordance with Annexes II and III. Full support for UDI implementation and EUDAMED registration.
Clinical Evaluation & PMCF
Preparation of clinical evaluations (CER) in accordance with MDR Annex XIV. Planning and conducting post-market clinical follow-up (PMCF) studies to ensure the ongoing collection of evidence.
Post-Market Surveillance (PMS)
Development of proactive PMS plans, preparation of PSURs, and systematic market surveillance. We ensure compliance with your reporting obligations for serious incidents in accordance with Article 87 of the MDR.

What is the process for an MDR project with ENTOURAGE?

From the initial analysis to ongoing compliance—our proven 5-phase process keeps you informed about the project’s progress at all times.

01

Initial consultation

Free analysis of your current situation: product classification, existing documentation, timeline, and budget.

02

Gap Analysis

Systematic review of your technical documentation against all MDR requirements. Prioritized action plan.

03

Implementation

Our MDR experts work as part of your team: technical writing, clinical evaluation, PMS plan, and UDI implementation.

04

Mock Audit

Mock audit conducted by experienced auditors. Identification of any remaining weaknesses prior to the Notified Body audit.

05

Audit & Follow-up Support

Support during the audit. Post-market support for ongoing compliance and PSUR cycles.

JN
“MDR is not a one-time project, but an ongoing compliance process. Anyone who focuses solely on obtaining approval without establishing post-market structures will face the same problem in 24 months.”
Dr. Jennifer Neff — Head of Medical Devices, ENTOURAGE

Regulatory updates in video format.

Entourage Regulatory Briefings

Don’t miss any deadlines or regulatory changes. In our regular video updates, our experts provide practical summaries of the most important developments related to the MDR and IVDR.

Free White Paper

Software as a Medical Device & AI Act

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Frequently Asked Questions About the EU MDR.

Which products are covered by the MDR?
The MDR covers all medical devices in Classes I through III (e.g., implants, software/SaMD, accessories). In vitro diagnostic medical devices fall within the scope of the IVDR.
What is the main difference between MDR and MDD?
MDR 2017/745 imposes significantly stricter requirements: more rigorous clinical evidence requirements, the EUDAMED database, expanded post-market surveillance obligations, and new classification rules that result in many products being reclassified into a higher category.
How long does MDR certification by a Notified Body take?
Typically 12 to 24 months—depending on the completeness of the technical documentation and the workload of the Notified Body. A detailed gap analysis can significantly shorten this process.
What is EUDAMED, and who needs to register?
EUDAMED is the European database for medical devices. Manufacturers must register as economic operators and record all products placed on the market in the EU in the database using a UDI-DI.
Do you also support manufacturers of Class I products?
Yes. Even for Class I devices, the MDR requires complete technical documentation and a declaration of conformity. For sterile devices or devices subject to metrological requirements (Class Is/Im), a Notified Body must also be involved.
How much does MDR consulting cost?
The cost depends on the scope of the project: product class, number of products in the portfolio, and the condition of the existing documentation. A typical project for a single Class IIa product ranges from €30,000 to €80,000. A free initial consultation will help determine the specific cost.
Can you also recertify legacy products under the MDR?
Yes. The transition of existing MDD certificates to the MDR is one of our core competencies. We analyze your existing documentation, identify the additional requirements, and develop a prioritized recertification plan that adheres to the transition deadlines.

Additional expertise in regulatory affairs.

Expertise

IVDR Readiness

Strategies and Implementation for Manufacturers of In Vitro Diagnostic Devices.

 Expertise

Post-Market Surveillance

PMS plans and PSURs to comply with MDR market surveillance requirements.

 Expertise

Technical Writing

Organization and structuring of technical documentation.

Speed up your MDR certification.

Save valuable time and resources. Our experts will organize your documentation so it is ready for audit by the Notified Body.

Submit a project inquiry.

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