RAPS Workshop: EU Medical Device Regulation 2017/745

The EU Medical Device Regulation (MDR) has certainly caused significant impact to the medical device industry. Regulatory and quality professionals are still learning some of the nuances, and with the extended time frame for compliance, some companies are still navigating their way through the requirements.

If you are unsure of what is required, then join us as we explore the nuances of the regulation and make sense of what you need to do in a practical way, with easy-to-understand examples.

Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.

Learning Objectives

Upon completion of this workshop, participants will be able to:

Appreciate the history, purpose and structure of the MDR
Identify devices covered by the MDR and how to classify them
Know what manufacturers, economic operators and the PRRC are required to do
Understand the GSPRs and features of a risk management system based on ISO 14971
Explain the contents of the technical documentation
Apply PMS and Vigilance requirements for different device classes
Outline the basic clinical data requirements
Identify the UDI requirements and the relationship with Eudamed

Who Should Attend?

There are no formal pre-requisites required for this course. This course applies to anybody that requires an understanding of the EU MDR.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

Time	Topic
Online Self-Paced (Pre-Course)	Why do we have the MDR? Key Stakeholders Structure of the MDR MDR current timelines Terminology and definitions
Day 1	Devices covered under the MDR CE Marking Placing a device on the market Manufacturer’s obligations Other economic operator & PRRC responsibilities Declaration of conformity
Day 2	Procedure packs, spares and components How classification works (Annex VIII) Classification rules Navigating routes to conformity General Safety and Performance Requirements (GSPRs) GSPR Chapter I General Requirements
Day 3	Risk Management GSPR Chapter II Design & manufacture requirements GSPR Chapter III Device Information Unique Device Identification (Annex VI) UDI Timelines Overview of Eudamed
Day 4	Technical documentation (Annex II & Annex III) Clinical Evaluation Clinical investigations Summary of Safety and Clinical Performance Post Market Surveillance (PMS) Post Market Clinical Follow-up (PMCF) Vigilance

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].

Speakers

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