What is EU MDR?
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 understand:
- The MDR’s additional requirements
- The current directives - MDD 93/42/EE and ISO 13485:2016
- Terminology and certification requirements
- Introduction to MDR
- Implementation timelines
- Regulatory expectations against various chapters
- General overview of guidance as Annexes:
- General safety and performance requirements
- Technical documentation I
- Technical documentation on post-market surveillance
- EU declaration of conformity
- CE marking of conformity
- Information to be submitted upon the registration of devices including UDI system
- Requirements to be met by notified bodies
- Classification rules
- Conformity assessment based on a quality management system and assessment of the technical documentation
- Conformity assessment based on type examination
- Conformity assessment based on product conformity verification XII Certificates issued by a notified body
- Procedure for custom-made devices
- Clinical evaluation and post-market clinical follow-up
- Clinical investigations
- List of groups of products without an intended medical purpose
Who should attend?
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.