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.
How will I benefit?
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 attend?
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.
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
What is included?
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
Contact us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
Notes:
This is an online, interactive eLearning course, You’ll have access to the course for 12 months.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.
