An Introduction to the EU Medical Device Regulations
Training Course Information
In this training course you will gain a good understanding of the European Union (EU) Medical Device Regulation (MDR) 2017/745, and how this regulation is implemented. In the course the following topics will be discussed:
- What is the EU MDR 2017/745?
- Definition of a Medical Device – Article 2
- Classification of a Medical Device – Annex VIII
- The Role of Notified Bodies
- Manufacturers Obligations (Article 10)
- Quality Management
- The Role of a PRRC (Article 15)
- Authorised Representatives (Article 11)
- Regulatory Requirements – Annex I
- Consensus Standards
- Technical Documentation – Annex II
- Technical Documentation on Post Market Surveillance – Annex III
- Clinical Evaluation
- Declaration of Conformity
- CE Marking
- Medical Device Registration and EUDAMED
- Post Market Surveillance and Vigilance
How will this course benefit me?
This course will benefit anyone who works in the medical device industry and place medical device products on the EU market.
By the end of the course you will understand how medical devices are regulated in the EU and the following key elements:
- how to identify if a product is a medical device;
- how to classify a medical device in the EU;
- understand the regulatory pathway involved based on the classification of the medical device;
- understand the role of Notified Body’s;
- understand the obligations of medical device manufacturers;
- gain an understanding of requirement for Quality Assurance Systems;
- understand what a PRRC is and the role in a medical device organisation;
- understand what an Authorised Representative;
- understand the regulatory requirement and how some apply and others don’t apply depending on the type of medical device ;
- how to apply standards to demonstrate compliance to the regulatory requirements;
- learn how a technical file is put together
- learn how clinical evaluation works;
- learn how to write a declaration of conformity;
- how to apply the CE mark;
- learn about medical device registration and the EUDAMED system;
- and how to perform PMS and Vigilance.
How is the training delivered?
Training is delivered through Microsoft teams, where there will be a live Patient Guard training instructor who will deliver the course over a 2 hour session.
The training course will be delivered to a maximum of 4 participants, this is to allow a more intimate training environment where time can be given to provide answers to specific questions participants may have in relation to the content or how it may impact their organisation.
Will I get proof I have been on the course?
At the end of the course each participant will be given a certificate of completion and attendance for the course. This can be used as evidence that you have attended an awareness course in relation to the EU MDR 2017/745.
Will I get any training materials?
Once the course has been completed you will be sent by email a copy of the presentation and course materials.
How do I book my place?
To book a place on this course please email us following the link below. Please note that due to limited availability bookings can only be cancelled one week before the course is due to take place. If cancelled after this time the full fee will be payable.
