Requirements of the MDR for CE Marking Training Course

This one-day medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers.

This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors.

After completing this medical device training, you will have a sound understanding of the medical device regulation and be able to communicate it to others. You will also gain eight CPD points and take away comprehensive training course notes.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

The course will give you an understanding of the key requirements, which will provide:

Essential knowledge to understand Regulatory Affairs of Medical Devices
in EU, e.g. in the position of top management, or a manager or project
member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
A basis to learn later about implementation of CE-marking projects

Skills to be acquired

By the end of the course, delegates will be able to:

Communicate the key requirements and concepts within the Regulation
Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
Define the vocabulary used within MDR
Explain the structure and administration of the Regulation
Recognize partners of manufacturers affected by the Regulation
Describe key steps of a conformity assessment
Explain the main impacts on the QMS relating to MDR
Recognize requirements for postmarket surveillance and updates

Targeted audience

New starters in Regulatory Affairs (RA), personnel increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.

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 signedSkills