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 will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be 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 will also affect (supplier) audits and governmental control; introduce new partners to interact with, and increase 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 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

How will I benefit?

This course will help you:

• Understand the key requirements and concepts of the European Medical Devices Regulation
• Communicate the impact of the key requirements introduced by the MDR to your organization

What will I learn?

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 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

Who should attend?

The course is especially suitable for:

• 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.

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.

Duration

1 day

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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.

Further information

This course will focus on the overall requirements of MDR, and not on specific devices or implementation issues.

Detailed course notes are provided.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Related training

IVDR courses.

Please refer to our 3-day-course for implementation of the MDR.

Clinical evaluation and risk management.

MDD to MDR transition course.