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

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 Economic 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

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >


Classroom-based training: Ready when you are

When you’re ready for face-to-face training again, we’re ready to welcome you.

As we all adjust to greater freedom around travel and meetings, we want to reassure you that our training team has worked with venues and tutors to enhance measures to keep you safe. Our carefully selected training venues continue to operate social distancing procedures, with readily available sanitizer stations at high-touch points throughout the venue. Rigorous deep cleaning procedures continue, providing you with peace of mind during your time at the venue.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.