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Formazione >> Webinar e Formazione Online >> EU MDR: State of play and challenges to compliance

EU MDR: State of play and challenges to compliance

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: February 21, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

ATTENDEES CAPACITY: 250 delegates

SUBMISSION LINK:  This webinar has already reached maximum capacity

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction and overview

The European Commission’s Medical Device Regulation, first published in May 2017, became applicable in all European member states in May 2021. New devices will have to meet the requirements of the MDR in order to be placed in the European market.

A higher compliance bar under the MDR:
The new regulation has created a huge compliance on costs and related processes. A report from Reuters has underlined how medtech companies are stopping to sell in the EU market while doctors’ groups are already reporting medical equipment shortages.

EU leaders have become aware of the problems. The European Commission has recently published the official text of its proposal to amend the transitional provisions for certain medical devices. Key proposals include the exstension of the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices.Medical device manufacturers are well-advised to stay up-to-date on the advancement of the MDR.

This webinar aims to sum-up these important updates and all the progress done during these years of the MDR coming into force. Valuable highlights to ensure a smooth transition to the new requirements will be discussed from our expert by helping manufacturers and stakeholders on advanced preparation and early action.

Agenda

• Normative introduction to MDR: differences with MDD

• Overview of the main changes, such as:
   o Product scope expansion
   o Economic operators
   o Reclassification
   o Clinical data additional requirements
   o The Person responsible for regulatory compliance

• State of play:
   o Extension of the transition period
   o EUDAMED
   o Standard Harmonisation
   o MDCG Rolling Plan

Speaker

Daniele Lioi,
HAS Consultant, Senior Consultant at Eurofins Medical Device Testing Italy