Requirements of the Medical Device Regulation for CE Marking Training Course

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.


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

 

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

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-3460780.

Combination discount

Attending several medical device courses is associated with special discount

No.

Training

Price

 

1

 Transition or Requirements MDR-IVDR

    € 750

 

2

 Implementing CE Marking MDR-IVDR

    € 1.950

 

 

 Total

    € 2.700

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 2.600

€ 100

For more information about combination of courses or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com


In-company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

 For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to mark.leenaers@bsigroup.com