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
Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
Please note: This course does not focus on mapping the 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.
By the end of the course delegates will be able to:
- Explain the changes in the structure and administration of the regulation
- Recognize new economic operators affected by the regulation
Identify key changes to the requirements concerning the following steps for conformity assessment:
- Check device is within the scope of the MDR
- Determine risk class of device
- Select conformity assessment procedure
- Identify applicable safety and performance requirements
- Assemble technical documentation
- Apply conformity assessment procedure
- Assign unique device identification (UDI)
- Complete Declaration of Conformity (DoC)
- Affix CE mark
- Post-Market Surveillance and Updates
Explain the main impacts on the QMS relating to the above steps, including:
- Frequency, extent and conduct of audits
- Electronic data management and public access to data
- Clinical investigations, clinical evaluation and post-market surveillance
- Roles of commercial partners
Communicate the transition arrangements as stipulated within the regulation.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
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- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.