Date: 18 October 2022
Time: 15:00-16:30 CEST
Location: Virtual
Language: English
Costs: € 295,-
Package deal: € 3500.-* for all 11 sessions
€ 1399.- for 4 sessions
* Team Members with different roles and responsibilities? No problem. We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
Introduction
The Medical Devices Regulation (MDR) is the legislation setting out the requirements that manufacturers must meet in order to market medical devices in the European Union. It affects all manufacturers, importers, distributors and representatives of medical devices within the EU. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC).
Agenda:- CE Mark & The EU
- Role of Notified Bodies, Competent Authorities and Others
- Purpose of the MDR
- Core changes MDD to MDR
- Timelines
- Q&A
Who should attend?
Manufacturers of medical devices, especially: Regulatory Affairs, Clinical Affairs Specialists and Quality Assurance specialists.
Trainer: