Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition training course

Course overview

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.

This long awaited text brings with it more scrutiny of technical documentation, including clinical evaluation and post-market clinical follow-up, and traceability of devices through the supply chain.

Our one day training course has been designed to introduce medical device manufacturers and other economic operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR).

Who should attend?

  • Medical device manufacturers, especially if your role is in:

• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance

  • Authorized Representatives
  • Economic Operators, including importers and distributors
  • Consultants

What will I learn?

You will learn about the:

  • Changes in the structure and administration of the Regulation
  • New Eonomic Operators affected by the Regulation
  • Key changes to the requirements 
  • Scope of the MDR
  • Device classification
  • Conformity Assessment Procedures
  • Safety and Performance Requirements
  • Requirements for technical documentation
  • Unique Device Identifiers (UDI)
  • Declaration of Conformity
  • Post-Market Surveillance and vigilance    
  • Transition arrangements as stipulated within the Regulation

How will I benefit?

On completion of this course, you will be able to:

  • Understand the key changes in the transition from the MDD to the new MDR
  • Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR
  • Identify the next steps for your organization to meet the MDR requirements

What's included?

  • Training course notes
  • Lunch 
  • Refreshments

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.