Implementation of MDR for CE Marking training course

This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR).

The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers. You will learn all the requirements needed for conformity assessment, how to fulfill technical documents and how to plan post-market activities required by the MDR.

By the end of the course you will be able to put all this knowledge into working practice in your organization.

Prerequisites

You must have a good understanding of the requirements in the MDR, which is conveyed by our one-day Requirements training course or our MDD to MDR transition course.

You should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre or post-market
activities within the EU.

Pedagogical objectives

Implement the requirements of the European Medical Devices Regulation
Guide and support other people and partner organizations affected by MDR
Set up and update required documentation
Take the necessary steps for your organization to meet the MDR requirement
Maintain compliance to MDR and other/future documents related to Medical Device legislation
Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts,standards)

Skills to be acquired

Develop a strategy for regulatory compliance as stipulated by MDR
Implement requirements concerning the following steps for Conformity
Assessment
Scope and applicability of MDR
EU risk classification criteria for medical devices to determine “Risk
Class”
General Safety and Performance Requirements (GSPRs) as the basis for
CE marking, including the use of standards
Conformity assessment routes and their application based on risk class
Self-certification, CE-certification by Notified bodies, involvement of
authorities, scrutiny
‘Declaration of Conformity’ and CE marking
Fulfil Technical Documentation requirements, e.g. in:
Putting together ‘Technical Documentation’
Necessary control of outsourced activities and processes and roles of
external partners (e.g. supplying and commercial)
Instantiate the importance and role of clinical data
Risk management, process validation and their regulatory significance
Drawing up Instruction For Use, label and other information supplied with the device
Consistency and validity of information and electronic data
management
Plan post-market activities required by MDR with respect to:
Risk Management and related planning
Post-Market Surveillance and Post-Market Follow-Up (PMCF)
Periodic reports, Vigilance, ad-hoc reporting
Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
Regulatory relevance of change control to QMS, design and manufacturing
Extent of readiness for audits/reviews/assessment
Put into effect gained knowledge concerning implementation of MDR
requirements into your organization, e.g. in projects for CE-marking

Targeted audience

RA, QM, and QA professionals who need to implement the MDR
Anyone concerned with certification or active in projects for CE-marking
Staff working for organizations that partner with Medical Device
manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized
representative, importer, distributor, auditee

Pedagogical, technical and framing means

Course materials including:

Introduction to the training, detailed program and security assignments
Course presentation, theory and activities/ role plays
Answers to the activities
Videos
Additional documents, distributed during the sessions, to use for the
activities
Attendance sheet to be signed