Requirements of the MDR Article 117 Classroom Training

Combinations of Medicinal Products and Medical Devices: Requirements of the MDR Article 117 and the Impact on Product Documentation Training

Requirements of the MDR Article 117 Classroom Training

Level Requirements Duration 1 day

Available to book: Public classroom View dates and book now

This course is designed to provide you with an understanding of the requirements of Article 117 and the impact of these requirements on the documentation needed to obtain market approval and post-market approvals for medicinal products with an integral medical device.

It will also provide you with a general overview of the new Medical Device Regulation (MDR 2017/745) and of the activities involved in demonstrating conformity with the relevant general safety and performance requirements of a medical device.

Practical activities throughout the day will give you the opportunity to test your new knowledge and to discuss relevant scenarios with the other delegates.

How will I benefit?)

This course will help you:

Obtain basic knowledge of the MDR
Be familiar with the key activities involved in demonstrating conformity with the relevant GSPRs for a medical device
Determine whether Article 117 is applicable to your product
Outline an overall documentation strategy for a medicinal product used with a medical device
Help and guide your organization in the development and preparation of documentation for medicinal products with an integral medical device

After completing this training course, you’ll be able to:
- Appreciate the background and content of the Medical Device regulation (MDR)
- Identify the classification of medical devices
- Explain the General Safety and Performance Requirements (GSPRs), at a high level
- Interpret the meaning and requirements of Article 117 of the MDR
- Identify the impact of Article 117 on the planning and preparation of Marketing Authorization Approvals (MAAs) for medicinal products with an integral medical device
- Facilitate collaboration between the pharmaceutical department and the medical device department within your organization
Anyone involved in the planning of or preparation of documentation to support medicinal products with an integral medical device. For example,

Regulatory Affairs, (Chemistry, Manufacturing and Controls (CMC)), QA, Clinical and Project Managers.
- On completion, you'll be awarded an internationally respected BSI Training Academy certificate
- Detailed course notes
- Lunch and refreshments
- Loan copy of the standard (to be returned after the course)
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com

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