Course Aim: Learn about the key changes to requirements for CE marking following the publication of the new Medical Device Regulation (MDR). The changes will affect all medical device manufacturers, importers, distributors and EU Representatives. Manufacturers of some classes of devices without a medical purpose (for example, devices used for body modification, contact lenses to change eye colour without correcting vision, etc.) will also be affected.
Course Description: The Medical Devices Regulation has replaced the Medical Device Directive (93/42/EEC) as the legislation detailing the requirements which manufacturers have to meet to place medical devices on the market in the European Union. Publication of the text in spring 2017 marked the start of a three year transition period for manufacturers to meet the new requirements.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.
The new requirements will also have implications relating to an organization’s quality management system (QMS), specifically: Auditing, requirements for clinical evaluation and technical documentation, post-market surveillance, vigilance reporting, and accessibility of information across European member states, as well as to the public and end users.
Please note: This course does not focus on mapping the active implantable medical devices (AIMD) to the MDR, however, the course will provide value to AIMD clients by looking at the new regulation and how to transition to the MDR. It will also not cover In Vitro Diagnostic Devices.
How will I benefit?
This course will help you:
- Understand the key changes in the transition from the Medical Devices Directive to the new Medical Devices Regulation
- 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 requirement
