4-Day Virtual Seminar

In Depth EU Medical Device Regulation (MDR) 2017/745 Training

BY: Juan M Campos, Owner, JMC Medical Device Consulting

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

November 2-5, 2020
(11:00 AM to 3:00 PM PDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

New EU Medical Device Regulation (MDR 2017/745) will substitute on 21-May-2021 the EU Medical Device Directive (MDD 93/42/EEC) which has been the medial device regulatory framework for CE mark and commercialization in all countries of the EU during the last 27 years. No question this is a big regulatory change that will directly impact thousands of medical device companies worldwide currently placing in the EU market their products or planning to do so.

The seminar will provide an in-depth knowledge of the new MDR, divided into 10 subject specific modules all of them including case studies and tests to ensure verification of training effectiveness. Quality and Regulatory professionals attending this seminar will be able to ensure compliance with new MDR requirements and secure the CE mark of those medical devices already in the EU market under previous MDD requirements, as well as those new devices planned for EU distribution after 21-May-2021. Additionally this seminar will provide these professional with the training evidence required by Regulatory Authorities (EU Notified Bodies and Competent Authorities) to take the new Person Responsible for Regulatory Compliance (PRRC) role mandated by MDR.

Learning Objectives:
  • The medical device professionals attending this seminar will get an in-depth knowledge of the new EU Medical Device Regulation (MDR) 2017/745 that will be mandatory on 26-May-2021.
  • This knowledge will permit to ensure those products currently in the EU market under Medical Device Directive (93/42/EEC) continue in the market after 26-May-2021, as well as successfully planning how to obtain MDR CE mark for all new products after that date.
  • This seminar will also provide the required training evidence to comply with the Person Responsible for Regulatory Compliance (PRRC) role required by MDR.
Who will Benefit:

Medical Device industry currently selling or planning to sell in the European Union (EU). Specific roles that will directly benefit from this seminar are:

  • Quality Assurance Managers / Directors / VPs
  • Regulatory Compliance Managers / Directors /VPs
  • Regulatory Affairs Managers / Directors / VPs
  • Clinical Managers / Directors / VPs
Day 01(11:00 AM - 3:00 PM PDT)
  • Classification
    • Rules
    • New elements
    • Decision trees
    • Reclassified devices
    • Devices without medical purpose
    • Spine implants
    • Take away
    • Tests and Case studies
  • Custom made devices
    • Additional guidance documents
    • Adapted medical device
    • Patient matched medical device
    • Custom made device
    • Tests and Case studies
Day 02(11:00 AM - 3:00 PM PDT)
  • General Safety and Performance Requirements (GSPRs)
    • Required rationale
    • Matrix ?
    • MDR GSPRs vs MDD ERs
    • New approach
    • Required rationale
    • Tests and Case studies
  • Technical Documentation
    • Required contents
    • Record keeping
    • Important tips
    • New approach
    • Conformity assessment
    • Certification cycles
    • Tests and Case studies
Day 03(11:00 AM - 3:00 PM PDT)
  • Post market surveillance (PMS)
    • General
    • Periodic Safety Update Report (PSUR)
    • Summary of Safety and Clinical Performance (SSCP)
    • Reactive PMS
    • Proactive PMS
    • Post Market Clinical Follow-up (PMCFU)
    • Vigilance
    • Tests and Case studies
  • Clinical evaluation
    • General
    • Data sources
    • MDD vs MDR
    • Medical Device Coordination Group (MDCG)
    • State of the Art
    • Equivalence
    • Harmonised Standards & Common Specifications
    • Device performance
    • Tests and Case studies
Day 04(11:00 AM - 3:00 PM PDT)
  • Unique Device Identification (UDI)
    • Regulation
    • Timelines
    • Descriptions – Example
    • Database
    • Where in the QMS ?
    • New UDIs
    • Guidance documents
    • Tests and Case studies
    • Regulation
    • Coding system
    • Nomenclature
    • Modules
    • Data access & data entry
    • SRNs
    • Timeline
    • Tests and Case studies
  • Economic Operators
    • Definitions
    • Regulations
    • Authorised Representative
    • Importer
    • Distributor
    • Tests and Case studies
  • Person Responsible for Regulatory Compliance
    • Regulation
    • Qualification
    • Responsibilities
    • Tests and Case studies
Juan M Campos
Juan M Campos Owner, JMC Medical Device Consulting

Juan M. Campos is a Medical Device professional with + 33 years of continued industry experience. His main areas of expertise include Quality Assurance, Regulatory Compliance and Regulatory Affairs. He has led culturally and geographically diverse QA/RA teams in Spain, UK, France, Switzerland, Netherlands, Germany, Portugal, Italy, Greece and Turkey directly reporting to him. Additionally he has successfully coordinated global QA/RA projects with extended on site presence in USA and China.

Most of the Regulations that govern today’s Medical Device world (EU Medical Device Directive, US FDA CFR 21-820, ISO 13485, Japan MHLW, Australia TGA, Brazil ANVISA, Health Canada, China SFDA, etc) have been created, implemented and even revised several times during Juan’s 30 year daily industry activity in leadership QA/RA roles. Specifically Juan has successfully led both product international Regulatory Registration processes, together with Regulatory Compliance global projects to ensure full Quality System compliance with those Regulations (Quality System design and implementation, Regulatory Agency pre-inspection readiness, Regulatory Agency post-inspection remediation, M&A due diligence and post-merger integration, product quality claims & liability, etc) in manufacturing, subcontractor and distribution facilities around the globe.

Juan is also a certified SGS ISO 9001 Auditor, BSI ISO 13485 Lead Auditor and SGS MDR QMS Auditor & Product Assessor with extensive EMEA, China and USA on site audit experience, an active voting member of ISO TC150 CTN91 Implants and ISO TC210 CTN111 SC3 Quality Management Committees, as well as an active project evaluation expert at the BioExpert Network.

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November 2-5, 2020, Virtual Seminar


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November 2-5, 2020, Virtual Seminar

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