THE NEW EU REGULATION 2017/745 ON MEDICAL DEVICES
Understanding the Regulation and its impact on Industry
The EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical devices industry. Beyond the familiar framework of the Medical Devices Directive 93/42 based on general requirements for safety and performance, harmonized standards, risk classification, the new Regulation introduce novel requirements in key areas such as stronger Notified Body Oversight, improved General Safetyand Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance.
The Regulation also introduces a new responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors. The Regulation also brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments.
For the industry, it is just the right moment to get a detailed understanding of the new requirements and understand how to prepare for the end of the transition period in May 2020.
Date: 12-13 June 2019
Time: 09:30 am – 6:00 pm
Venue: Vienna, Austria
Cost: Early bird: € 1570* (until 15-05-2019)
Ordinary: € 1780*
Freelance – Academy – Public Administration: € 890*
* For Italian companies: + 22% VAT
The fee includes: tuition, teaching materials, lunches and coffee breaks, office assistance, attendance certificate
Complete booking and payment at this link and use code MVA1908 to book and receive 15% off.
For any further question feel free to contact Mara Claudia Algarotti email@example.com