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QA/RA Consulting, Auditing & Training

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

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

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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