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: September 28, 2023 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://register.gotowebinar.com/register/6213130633333577310
ATTENDEES CAPACITY: 500 delegates
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
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.
In this second edition of this webinar, we aim 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
Speaker
Daniele Lioi is a Senior Consultant and Team Manager of the Eurofins Italian Medical device consultancy team. Since 2017, he has been dealing with Biological Risk assessments, Clinical Evaluation and Supporting the compilation of the technical documentation for medical device manufacturers. He has a biotechnology background with experience in regulatory affairs of medical devices. Daniele recently obtained the qualification as Auditor/Lead Auditor ISO 13485/ISO 9001, he is included in the national registry for person responsible for regulatory compliance and he joined the HAS consultants team for the harmonization of International Standards.
Agenda
- Normative introduction to MDR: differences with MDD
- Overview of the main changes, such as:
- Product scope expansion
- Economic operators
- Reclassification
- Clinical data additional requirements
- State of play
- Standard Harmonisation
- Extension of the transition period
- MDCG Rolling Plan
