This one-day intensive course will give you a good understanding of Article 117 of the MDR and the impact that Article 117 has on the development process, the generation of documentation and the market and post-market approvals of medicinal products with an integral medical device. 

It will also provide valuable knowledge to facilitate collaboration across the pharmaceutical and medical device sections within an organization.

Course Aim

This course will 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.

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

What will I learn?

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

Who should attend?

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.

Duration

1 Day

How will I learn?

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you acquire the skills to apply your knowledge straight away. This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

You should have a basic awareness of the legal framework governing the development of medicinal products.

Please note: You’ll be undertaking live, web-based search activities, so you will need to bring along your laptop, tablet or smart device.

Further information

Detailed course notes are provided.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Related training

Requirements of the Medical Device Regulation (MDR) Training Course, Implementation of the Medical Device Regulation (MDR) for CE Marking Training Course.