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FDA and EU Medical Device Classification and Regulatory Pathway Training

Bringing a new medical device to market in the US or EU? Need to understand how the process works in each market? These are important considerations when choosing which market to pursue first. Using interactive discussions and workshops, we will cover the US FDA 510(k) and the EU CE Marking process in detail. You’ll walk away with a solid understanding of how the two markets overlap and differ and what will be required to gain US 510(k) clearance and/or CE Marking certification in Europe. 

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Brief Overview of This Medical Device Regulatory Pathways Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming FDA and EU Medical Device Classification and Regulatory Pathways Training Classes

SkillsLab $2895

SkillsLab $2895

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Training Class on Medical Device Classification and Regulatory Pathways

Learn to how to identify an appropriate regulatory pathway to obtain medical device approval or clearance in the United States or place a CE-Marked medical device on the market under Europe's Medical Device Regulation (EU MDR 2017/745). 

 

Course Overview
SkillsLab Class

US Submissions Strategy

  • Definition of a medical device
  • FDA medical device classification
  • Risk in regulatory submissions
  • Regulatory strategy and how to choose a pathway
  • FDA resources and communication options, including the pre-submission meeting
Exercise! FDA Product Classification Database
Exercise! Classify Devices

US Pathways to Market

  • FDA requirements to market a device in the US
  • Exemptions
  • Overview of US pathways to market
  • Identify pros and cons for the pathways

The FDA 510(k) Premarket Notification

  • Overview of the 510(k)
  • How to determine substantial equivalence
  • 510(k) contents; use of eSTAR
  • Mitigating risk in the submission
  • When to use a Special or Abbreviated 510(k)
  • The safety and performance-based pathway
Exercise! Evaluate Substantial Equivalence Arguments

The De Novo Request

  • When to consider a De Novo
  • The role of risk in a De Novo
  • Strategic benefits of the De Novo
  • De Novo request contents; use of eSTAR

The Premarket Approval Application (PMA)

  • PMA overview: Traditional and modular
  • Role of clinical trials
  • PMA contents; use of eSTAR
  • FDA panel meetings
  • Summary of safety and effectiveness (SSED)
  • Pre-approval inspections and post-approval study orders
Exercise! Writing an Effective Device Description

EU Medical Device Regulation (MDR) CE Marking

  • Placing a CE-Marked device on the market
  • EU MDR definition of a medical device
  • EU device classifications and rules
  • Conformity assessment routes
  • Additional requirements for certain devices
  • Technical documentation requirements, structure, and contents
  • General safety and performance requirements (GSPRs)
  • Role of common specifications
  • Life-cycle management of technical documentation
Exercise! Determining the Rule and Class of Devices Under the EU MDR

Submission Best Practices

  • Applying project management controls to submission development
  • Preparing a high-quality submission
  • Communicating effectively
  • Entering multiple markets more efficiently
  • Assessing the potential impact of reimbursement
Exercise! Recommend Regulatory Strategies
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Identify available pathways to market a medical device in the US as well as their advantages and disadvantages

Apply a strategy to recommend an appropriate regulatory pathway in the US for a medical device

Describe when to use a 510(k) premarket notification, De Novo request, or a premarket approval application (PMA)

Identify the needed contents for a 510(k) premarket notification, De Novo request, or a premarket approval application (PMA)

Explain how to establish substantial equivalence for a 510(k) premarket notification

Describe how to place a CE-Marked medical device on the market under the EU MDR

Identify the EU MDR’s conformity assessment routes

Describe the EU MDR’s technical documentation requirements for placing a medical device on the market

Identify regulatory submission best practices

Who Should Attend

Who Should Attend

Medical device quality and regulatory affairs professionals with a need to understand how to select an appropriate regulatory submission pathway for a medical device in the US and / or Europe. 

  • RA Professionals
  • QA Professionals
  • Regulatory Manager
  • Manufacturing Manager
  • RA/QA Team Members
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