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.
Online training: Connected Learning Live
Do you prefer the convenience of online training? View here for this training course or read more about Connected Learning Live.
Combination discount
Attending several medical device courses is associated with special discount
1. Transition or Requirements MDR-IVDR - € 800,-
2. Implementing CE Marking MDR-IVDR - € 2.150,-
| Training course | Investment | Discount |
| Combination training course 1 + 2 | €2.850 | €100 |
In-house training course
For more information about combination of courses or In-house training courses, please contact Training via +31 20 346 0780 or send an email to training.se@bsigroup.com.
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.
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
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
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.se@bsigroup.com or 0031-(0)20-346 0780.
