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
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Combination discount
Attending several medical device courses is associated with special discount
Medical Device Directive (MDD) to Medical Device Regulation (MDR) transition course - € 845,-
Requirements of the Medical Device Regulation (MDR) course - € 845,-
Implementation of the Medical Device Regulation (MDR) course - € 2.150,-
| Training | Price | Discount |
| 1. Transition or Requirements MDD-MDR | € 845 | |
| 2. Implementing CE Marking MDR | € 2.150 | |
| Total | € 2.995 | |
| Combination training 1 + 2 | € 2.895 | € 100 |
In-house training courses
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to training.se@bsigroup.com.
Who should attend?
- 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. We offer an equivalent training course for the requirements of the In Vitro Diagnostic Regulation.
Prerequisities
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
Delegates will be able to:
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 post-market surveillance and updates
Practical information
- It's a 1-day course
- The training will be delivered in the Dutch language (or in English when by all delegates required/approved)
- The materials will be provided in English
- Lunch and drinks are included
