Introduction to MDR (2017/745)
The course will thoroughly cover and explain the key areas that manufacturers, importers, and distributors need to understand to comply with the EU regulation
Course objective and outcome
The course is focused on the Medical Device Regulation 2017/745 and how manufactures of medical devices must act according to the legislation. The course will thoroughly cover and explain the key areas that manufacturers, importers, and distributors need to understand to comply with the EU regulation.
The most crucial aspect for manufacturers is to convince the authorities, such as the Notified Body and national health authorities, that their medical device is safe to use and fulfills the functionalities according to the intended purpose of the device. The course will guide you through the legislation explaining why the different requirements are important and which requirements that manufacturers should prioritize.
The trainer has an ongoing interaction experience with different Notified Bodies and the Danish Health Agency and has an updated knowledge of the focus areas and interpretation from the authorities within the key areas of the regulation.
Content
The learning goals of the course are:
- Knowing the main content of Article 10 (General obligations of manufacturers) and the expectations from the authorities
- Giving the basic requirements from the new Article 15 (Person Responsible for Regulatory Compliance)
- Knowing the basic UDI requirements
- Introducing the most important section of the regulation, Annex I (General Safety and Performance Requirements) and learning how to deal with the 184 requirements
- Going through the 22 Classification Rules
- Learning how the requirements for the technical documentation stated in Annex II can be solved
- Learn of the expectation to Annex III content and documents (Post Market Surveillance)
- Giving a broad introduction to Clinical Evaluation & Investigation area
- Introduction to the Conformity Assessment Procedure
- Content of the Declaration of Conformity
- Introducing some of the most important MDCG Guidelines
The course comprises lectures and interactive workshops. The trainer will follow up on learning objectives throughout the course. This means that you will have to answer questions on the topics covered to ensure that the objectives are met.
Who should attend?
- Persons working within the Regulatory and/or QA area
- Development engineers
- Design Control Specialist
- Development managers
The are no recommended minimum pre-requisites for this course.
Trainer
Søren Lyngsøe-Petersen, CEO, Pharma4ever QA