EU Medical Device Regulation (EU MDR)

  • Overview
  • Services
  • Experts
  • Why Work With NSF

The Medical Device Regulation (EU MDR) 2017/745 introduced major changes for manufacturers placing devices on the European market. To obtain a CE mark and access to the EU market, understanding and complying with the MDR is a must.

NSF International provides tools and solutions to ensure compliance with the EU MDR. We do this through a range of consulting services, including regulatory and clinical strategy planning, quality audits, training courses and the development of regulatory submissions.

Services

We provide training and education, regulatory and clinical support, and quality systems implementation and auditing services to help you navigate significant EU MDR changes. These include device classification, new and increased obligations for economic operators, requirements for technical documentation, and clinical evidence.

Online eLearning Courses

  • EU MDR - A Comprehensive Overview (virtual eLearning, two hours) 
  • EU MDR - Preparing Your Quality System (webinar)
  • EU IVDR - A Comprehensive Overview (virtual eLearning, two hours)

Instructor-Led Classroom Courses
These offerings are available as private on-site or public courses.

  • EU MDR - Overview Training (one day)
  • EU MDR - Strategic Planning for the Coming Changes (two days)
  • EU MDR - Internal Auditor Course (three days)
  • EU MDR - Preparing and Reviewing Technical Documentation (two or three days)
  • EU MDR - Strategy for Regulatory Compliance Workshop (two days)
  • EU IVDR - Workshop (four days)

German Language Course Offerings

Regulatory and Clinical Support

Regulatory consulting

  • Define EU MDR regulatory strategy
  • Define economic operator strategy
  • EU technical documentation support
  • OEM/PLM strategy and supporting services
  • Postmarket surveillance activities

Technical documentation preparation and submission

  • Clinical evaluation plans and reports
  • Risk management file
  • Usability engineering file
  • Software validation
  • Process validation
  • General safety and performance requirements (GSPR) support

Clinical support

  • Define clinical strategy
  • Plan and prepare for clinical evaluations
  • Plan and support clinical investigations
  • Plan and prepare postmarket clinical follow-up activities

Other services

  • TechFile factory
  • OEM/PLM services

Quality System and Audits

Implementation (article 10 MDR)

  • QMS gap analysis
  • QMS advising and consulting
  • Implementation of procedures
    • Strategy for regulatory compliance and identification of applicable GSPRs
    • Management responsibilities
    • Risk Management
    • Postmarket surveillance (PMS) systems
    • Control of suppliers and subcontractors
    • Clinical evaluation including postmarket clinical follow-up
    • Registration in the electronic system (Eudamed)
    • Unique device identifier (UDI)
    • Communication with competent authorities, notified bodies and economic operators
    • Vigilance reporting

Audits

  • EU MDR QMS audits
  • EU MDR technical file readiness assessment
  • Mock audits in preparation for notified body audits

Experts

Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems. Our team also includes medical device specialists with an engineering, biomedical or science background. Our team includes:

James Pink, Executive Vice President, Consulting Services

Oliver Christ, Dipl. –Ing., Executive Vice President

Kim Trautman, Executive Vice President

Randolph Stender, Dipl.-Ing., General Manager

Tom Dzierozynski, Executive Vice President

Laurence Matheron, PharmD, Director

Why Work With NSF

We provide solutions tailored to client needs based on our extensive portfolio of services and comprehensive expertise. This is complemented by our regular involvement in standards development, ongoing projects with leading companies and close relationships with notified bodies.

Contact NSF International

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