The Medical Devices Regulation is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.

The Regulation affects all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers are also affected, as well as manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).

The MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, Post Market Surveillance (PMS), transparency and traceability. The requirements also affect (supplier) audits and governmental control; introduces new partners to interact with, and increases communication needs and obligations (e.g. contracts, reporting, documentation, and publication of information).

This course conveys key concepts of the European Medical Devices Regulation. All medical devices will need to undergo a Conformity Assessment Procedure based on the MDR requirements in order to be placed on the European Union market. You will gain understanding of the requirements stipulated within MDR.

Course Aim

Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.

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

• Essential knowledge to understand Regulatory Affairs of medical devices in the 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

What Will I Learn?

By the end of the course, you’ll 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 the MDR
• Explain the structure and administration of the Regulation
• Recognize partners of manufacturers affected by the Regulation
• Describe the key steps of a conformity assessment
• Explain the main impacts on the quality management system (QMS) relating to MDR
• Recognize the requirements for post-market surveillance and updates

How Will I Learn?

• This is an online, interactive on-demand course.
• Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.
• You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue
• During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned
• The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning

Who Should Enroll?

The course is especially suitable for:

• New starters in Regulatory Affairs (RA) and those increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
• Anyone 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.

Please note: This course will not cover In Vitro Diagnostic Devices. Please refer to the ‘Related training’ below if you need more detailed information e.g. for implementation.

Prerequisites

There are no formal prerequisites for this course, but participants will benefit from a basic knowledge of Medical Devices use, design, or manufacture and/or general understanding of quality management.

Duration

4 hours

Related Training

• IVDR courses.
• Please also refer to our training course for implementation of the MDR (3 days).
• Clinical evaluation and risk management.
• MDD to MDR transition course.

Modules

• Introduction to CE Marking and EU Legislation
• General Obligations Under the MDR
• Scope of the MDR
• Determine Risk Class of Device
• Selecting Your Conformity Assessment Procedure
• Amend and Maintain the Quality Management System (QMS)
• Identify Applicable Safety and Performance Requirements
• Assemble Technical Documentation
• Apply Conformity Assessment Procedure
• Assign Unique Identifications
• Complete Declaration of Conformity (DoC) and Affix CE-Mark
• Post-market Surveillance (PMS)
• Transition Arrangements