Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition (RTTP available)

This course is now available online

 

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).

 

> Course Flyer

 

"The course has been included in the list of registered public courses under the Reindustrialization and Technology Training Program."

 

Each company is subject to a funding ceiling of HK$500,000 in each financial year at the course commencement date.

Please click "here" for the details of RTTP. 

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
  • Lunch 
  • Refreshments

RTTP reimbursement

HK$ 934 ONLY (after RTTP reimbursement)

 

RTTP User Guide for Companies (PDF)