How will you benefit?

This course will help you understand the key requirements and concepts of the Regulation (EU) 2017/745 and Medical Devices Regulations 2002 and be able to apply your learning to work with Medical Device products within your business.

What you will learn?

The course will cover the following learning objectives:

• Overview of Regulation (EU) 2017/745 and Medical Devices Regulations 2002

• Essential knowledge to understand the key elements and responsibilities of ensuring compliance as a medical device,  for the following functions:

• R&D – design, development and manufacturer

• Supply Chain and Logistics

• Customers Services, Marketing and Sales

• Quality Management and Regulatory Affairs

• The basics of classifying a product as a medical device:

• Understanding the definition of a medical device

• Understanding the different classes of medical devices

• Applying the rules to your medical devices

• The requirements of different classes of medical devices

• Overview of the key sections of the technical file:

• The requirements of each section of a technical file

• Declaration of Conformity overview

• Basic understanding of processes:

• Understand the basics of CE and UKCA marking

• Understand the role of a notified body and when they are required

• Registration of your medical device in both the UK and EU

• Overview of the requirement of the Quality Management System (QMS) relating to MDR

• Overview of post market surveillance (PMS)

• Understanding the impact of Brexit and the changes in UK MDR

Who should attend?

The course is especially suitable for: 

• New starters in Regulatory Affairs

• Current Regulatory Affairs professionals increasing their responsibility to now be covering medical devices

• Current Regulatory Affairs professionals who are not familiar with the European MDR and UK MDR

• Anyone working with Regulatory Affairs departments

This training will not cover In Vitro Diagnostic Devices (IVD)

What's included?

This course will be held in person. The content material will be shared following the training course.