General Overview of the European Medical Device Regulation (EU MDR)
27th - 28th Feb 2021: General Overview of the European Medical Device Regulation (EU MDR) | Duration: 2 Days
Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products.
The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical Devices Regulation (MDR), was published in the Official Journal of the European Union on May 5, 2017. The Regulation (EU) 2017/745, covers medical devices and active implantable medical devices.
This regulatory frame work defines the expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. The regulation published on 5 May 2017 will came into force from 26 May 2020
This course will help you to understand:
- I General safety and performance requirements
- II Technical documentation I
- II Technical documentation on post-market surveillance
- IV EU declaration of conformity
- V CE marking of conformity
- VI Information to be submitted upon the registration of devices including UDI system
- VII Requirements to be met by notified bodies
- VIII Classification rules
- IX Conformity assessment based on a quality management system and assessment of the technical documentation
- X Conformity assessment based on type examination
- XI Conformity assessment based on product conformity verification XII Certificates issued by a notified body
- XIII Procedure for custom-made devices
- XIV Clinical evaluation and post-market clinical follow-up
- XV Clinical investigations
- XVI List of groups of products without an intended medical purpose
Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
Participants will be assessed through a 50 marks written examination at the end of the course. Minimum passing % criteria: 60%.
All participants who have completed both the days of training will be issued a TÜV SÜD South Asia’s certificate of attendance.
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Bosnia and Herzegovina