EU MDR 201: Advanced Application & Implementation Process of the EU MDR (2017/745)

EU MDR 201: Advanced Application & Implementation Process of the EU MDR (2017/745)

This course is a 2-Day Live Online Course for learners who have completed prior training on EU MDR (2017/745). It is designed to equip students with the advanced practical skills expected of a Subject Matter Expert. EU MDR 201 builds on the concepts learned in EU MDR 101, therefore we strongly advise completing EU MDR 101 before your EU MDR 201 advanced course date.

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Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market

The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:

  • If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be placed on the market.
  • If you have Class I devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and product's technical documentation needed to meet the new EU MDR requirements as of May 26, 2021.
  • If new products are launching, they are not covered by the MDD and therefore need to be conformant to the EU MDR.

Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market

The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:

  • If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be place on the market.
  • If you have Class 2 devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and documentation system needed to meet the new EU MDR requirements as of May 26, 2021.
  • If new products are launching, they are not covered by MDD

70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?

Here's just a few reasons:

  • They think that implementation can be completed in just a couple of months because they don't understand the magnitude of the regulation's impact on their day-to-day
  • They're overwhelmed by the sheer amount of information and complex provisions
  • Confused about where to begin
  • Skeptical of the expertise of training instructors
  • Insecure about their current level of knowledge regarding the regulation.

But we're here to make it easy for you.

70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?

Here's just a few reasons:

  • They're overwhelmed by the sheer amount of information and complex provisions
  • Confused about where to begin
  • Skeptical of the expertise of training instructors
  • Insecure about their current level of knowledge regarding the regulation.

But we're here to make it easy for you.

Hi, I’m Isabel Osorio

I have the unique experience of having worked as an Engineer, Lead Auditor and Certified Trainer for Notified Bodies, Consultant, and former member of industry throughout my 16 year career in the MDR field.

I’ve created this course, Advanced Application & Implementation Process of the EU MDR (2017/745)

specifically for those who want a deeper understanding of the practical applications of the regulation. This course is designed to position you as a Subject Matter Expert and leader in your role. This is a live 2-Day virtual course, where you will have the opportunity to ask questions in real-time to ensure confidence and competence upon course completion.

Hi, I’m Isabel Osorio

I have the unique experience of having worked as an engineer, auditor and as a member of industry throughout my career. I’ve been a consultant since 2019.

I’ve created Advanced Application & Implementation Process of the EU MDR (2017/745) specifically for those who want a deeper understanding of the practical applications of the regulation. This course is designed to position you as a Subject Matter Expert and leader in your role. This is a live 2-Day virtual course, where you will have the opportunity to ask questions in real-time to ensure confidence and competence upon course completion.

Who Is This Course For?

Engineers

Understand EU MDR (2017/745) so you can ensure products are compliant from phase one of design.

Members of Industry

If you sell or plan to offer medical device products or related services in the EU, this course is for you.

Supply Chain Management

Any company or individual with a role in supply chain management, import, export, distribution, and logistics related to products sold in the EU.

Quality Assurance (QA) & Regulatory Affairs (RA) Personnel

Professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles.



When it comes to competence, course delivery and trainer experience matters.

EU MDR 201 is the only online training course designed from the unique perspective of an EU MDR Certified Trainer with experience as a Biomedical Engineer, Lead Auditor for Notified Bodies, Consultant, and a former member of industry.

We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.

By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to ensure your Quality Management System and resulting products are compliant and conformant to the EU MDR (2017/745) regulation.

Practical Tools

We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.

Real-world Perspective

Isabel Osorio has the unique perspective of having experience both as an engineer AND an auditor. This means we teach exactly what systems you need in place in order to successfully pass an audit (and how to make them more efficient and less resource-draining).

Reimbursement Opportunities

Also, be sure to ask your employer for opportunities of reimbursement. You may qualify to take the course at no cost to you.

We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.

By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to implement proper quality test to ensure your devices are compliant and up to code.

Practical Tools

We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.

Real-world Perspective

Isabel Osorio has the unique perspective of having experience both as an engineer AND an auditor. This means we teach exactly what systems you need in place in order to successfully pass an audit (and how to make them more efficient and less resource-draining).

Reimbursement Opportunities

Also, be sure to ask your employer for opportunities of reimbursement. You may qualify to take the course at no cost to you.

Even if you understand the importance of starting now, you also don’t want to waste money on a subpar course

Maybe you have colleagues who have taken a course on this topic and were still unclear on it all. That won’t happen with this course.


What We Will Cover:

EU Legal Framework

Quality Management System Requirements

Risk Classification

Conformity Assessments

General Safety and Performance Requirements

Technical Documentation

What We Will Cover:

EU Legal Framework

Quality Management System Requirements

Risk Classification

Conformity Assessments

General Safety and Performance Requirements

Technical Documentation

Advanced Application & Implementation Process of the EU MDR (2017/745)

Course Outline: EU MDR 201

Advanced Application & Implementation Process of the EU MDR (2017/745)

Course Outline: EU MDR 201

EU legal framework

  • Entry into Force and Date of Application
  • CE Marking Requirements
  • EU Market Product Release Process
  • Legal framework on Release of Regulation 2017/745
  • UKCA mark
  • Structure of the Regulation
  • European Commission Objectives
  • Top Level Review of the Regulation
  • Responsibilities

Scope

  • Intended Purpose
  • Definition of Medical Device

QMS

  • Quality Management System Requirements
  • ISO 13485
  • ISO 14971
  • Language Requirements
  • Commons Specifications and Standards
  • MDCG Guidance Documents
  • Strategy for Regulatory Compliance
  • Competence of Persons and Authors
  • Liability Insurance
  • Certificate of Free Sale

Risk Class

  • Device Class
  • Device Risk Classification

Conformity Assessment

  • Pillars of Technical Documentation
  • Conformity Assessment
  • Routes to Conformity
  • Quality System Based Assessment Annexes
  • Product Based Assessment Annexes
  • Assessment Route Considerations

GSPRs

  • General Safety and Performance Requirements
  • General Requirements
  • Types of Information Supplied with the Device
  • Clinical Evaluation
  • Clinical Investigations
  • SSCP

Technical Documentation

  • Content and General Requirements

Apply

  • MDR Designated NBs and MDR Codes
  • NB Conformity Assessment
  • Additional Procedures
  • Certificate Scope
  • SRN, UDI, EUDAMED

Marking

  • DoC and CE Marking


PMS+

  • Post Market Surveillance and Updates
  • Post Market Surveillance
  • PSUR
  • Post Market Reports
  • Plans needed under the MDR
  • Vigilance
  • Actions of Competent Authorities after Report
  • FSCA and FSN
  • Grace Period and Significant Changes


PMS+

  • Post Market Surveillance and Updates
  • Post Market Surveillance
  • PSUR
  • Post Market Reports
  • Plans needed under the MDR
  • Vigilance
  • Actions of Competent Authorities after Report
  • FSCA and FSN
  • Grace Period and Significant Changes
People are praising EU MDR

What makes them love us?

EU MDR 201 brings this complicated topic to life with real life examples from a former member of industry so you can plan your implementation with confidence.

Stay ahead of the curve and certify your competence in the updated EU MDR regulation (2017/745).

FAQ's

  • RA, QM, and QA professionals
  • Medical device industry employees
  • Consultants
  • Auditors
  • Regulatory personnel
  • Purchasing department personnel
  • Employees of companies that provide contracted services to Medical Device Manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, testing house
  • Clinical research professionals conducting trials of medical devices on devices in the EU or planned devices to be placed into the EU market
  • Contract Research Organizations
  • Individuals seeking work opportunities in the medical device industry
  • Employees of a contract manufacturing company
  • Any service provider for the medical device industry
  • Anyone who is part of the supply chain
  • Managers
  • CEOs
  • CFOs
COURSE CONTENT
  • Preface:
    • Welcome and Introduction
    • Course Objectives
    • Course Content and Structure
    • Course Materials and Format
  • EU legal framework:
    • Entry into Force, Date of Application, and Transitional Provisions
    • CE marking
    • EU Market Product Release Process
    • Legal framework on Release of Regulation 2017/745
    • UKCA mark
    • Structure of the Regulation
    • European Commission Objectives
    • Top Level Review of the Regulation
    • Responsibilities
  • Scope:
    • Intended Purpose
    • Definition of Medical Device and Accessories
  • QMS:
    • Quality Management System Requirements
    • ISO 13485
    • ISO 14971
    • Language Requirements
    • Commons Specifications and Standards
    • MDCG Guidance Documents
    • Other Requirements:
      • Strategy for Regulatory Compliance
      • Competence of Persons and Authors
      • Liability Insurance
      • Certificate of Free Sale
  • Risk Class:
    • Device Class
    • Device Risk Classification
  • Conformity Assessment:
    • Pillars of Technical Documentation
    • Conformity Assessment
    • Routes to Conformity
    • Quality System Based Assessment Annexes
    • Product Based Assessment Annexes
    • Assessment Route Considerations
  • GSPRs:
    • General Safety and Performance Requirements
    • General Requirements
    • Types of Information Supplied with the Device
    • Clinical Evaluation
    • Clinical Investigations
    • SSCP
  • Technical Documentation:
    • Content and General Requirements
  • Apply:
    • MDR Designated NBs and MDR Codes
    • NB Conformity Assessment
    • Additional Procedures
    • Certificate Scope
    • SRN, UDI, EUDAMED
  • DoC and CE Marking
  • PMS+:
    • Post Market Surveillance and Updates
    • Post Market Surveillance
    • PSUR
    • Post Market Reports
    • Plans needed under the MDR
    • Vigilance
    • Actions of Competent Authorities after Report
    • FSCA and FSN
    • Grace Period and Significant Changes
  • Additional Information
Yes, students will receive a “Certificate of Completion” issued by an EU MDR 2017/745 Certified Trainer.
This live 2-day course is delivered online via our virtal classroom. Learners will have the opportunity to engage with their instructor and ask questions in real time.
Students will receive a copy of all course materials, including the student handbook, a “Certificate of Completion” issued by an EU MDR Certified Trainer upon completion, and access to MDR Consultants one-to-one consultation packages to assist you with planning your transition to the EU MDR (2017/745) Regulation (additional fees for one-to-one consulting apply).
2 days.
This course is currently offered in English only.
Yes, we do! As this course is delivered by an EU MDR Certified Trainer, in most cases employers will cover the cost of this course. You can download the information package here: EU MDR Trainer Qualifications Package EU MDR Trainer Qualifications Package
No – your course fee covers all of the materials you need to successfully complete the learning objectives.
Yes! Please contact us to tell us more about your needs: info@mdrconsultants.com info@mdrconsultants.com

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