This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry with an in-depth understanding of the application under the European Union’s Medical Device Regulation (EU-MDR 2017/745) Regulation.
Who is it for?
This course is for those involved in ensuring compliance with and needs an in-depth understanding of the application under the European Union’s Medical Device Regulation (EU-MDR 2017/745).
1. Explain the history, purpose, and structure of the EU-MDR, and the key terminology used throughout the regulation, and identify the types of devices covered by the EU-MDR and the rules for classifying these devices.
2. Describe the obligations of the economic operators and the Person Responsible for Regulatory Compliance (PRRC)
3. Describe and demonstrate understanding of the General Safety & Performance Requirements (GSPRs) and the key features of a risk management system based on ISO 14971.
4. Describe the contents of the technical documentation and demonstrate understanding of the requirements for post-market surveillance, vigilance, and clinical data.
5. Explain the Unique Device Identifier requirements and the relationship with European Electronic Database (EUDAMED).
Recommended prior knowledge
Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) training course or equivalent.
Medical device management systems
Knowledge of the following quality management principles and concepts:
The relationship between ISO 13485 and the EU-MDR 2017/745.
Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
A working knowledge of risk management principles related to the design of a medical device, through ISO 14971.
Learners will be assessed through continuous assessment focused on the five learning outcomes and 1 hour 35 minute examination.