Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition training course
IVD and Medical Devices Regulation Training
BSI has always worked hard to understand the current regulatory requirements in order for us to create training solutions that meet the needs of your organization. We work to ensure our training is robust, accurate and offers value to clients, whether we are training on existing standards, legislations, or business improvement. We are one of few certification bodies offering diverse medical device training portfolios consisting of specialized training courses.
BSI is currently working on our in-depth interpretation of the MDR and IVDR, published in May 2017, and as such will not be offering training to the new Regulations until we can offer you detailed and accurate transition courses. As part of our Notified Body re-designation work, we are currently furthering our understanding and clarifying areas, which we believe, are not fully clear with the current information available.
As such, we are planning to launch our new transition training courses, incorporating the MDR/IVDR in early 2018 once we are clearer about the interpretation of some the new requirements and how they will affect your organization.
Please express interest with us now and we will follow up with you once the courses are available.
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
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
- Training course notes