SAVE THE DATE - EU 2017/745 on medical devices one year after entry into force
Publication date: 29/04/2019
Are you ready for May 26, 2020?
On May 26, 2017 the New EU Regulation 745/2017 (MDR) on medical devices came into force, which will become executive in exactly one year. Are you ready to comply with the new requirements that will be in force from 05/26/2020? One year from the deadline for compliance with the provisions of the new MDR it is good to know the impact that the regulation will have on manufacturers and medical devices as well as on what Notified Bodies will require, in order to plan the actions to be taken to get ready for May 2020, and address all regulatory changes.
This is the objective of the event, which will be held on May 28, 2019 at the Modena Chamber of Commerce, organized by Confindustria with the collaboration of ISEMED srl, a consulting company on medical devices, and TÜV SÜD Italia srl, Organism Notified of primary international importance.
Eng. Guido Bonapace, CEO of ISEMED, which will illustrate the main innovations introduced by the MDR and the consequent impact on products, their classification and the quality system with the related tasks and responsibilities attributed to the manufacturers of medical devices.
TÜV SÜD Italia will be attended by Dr. Daniele Nistri, Trainer for MDR and Lead Auditor for ISO 13485 and MDD, who will address the issue of the new operating methods of the Organisms themselves in the face of the new requirements, and the consequent certification process, putting in evidence what will change compared to what was previously required by Directive 93/42 / EEC. It will also address the aspects of co-validation of the EC medical device certificates according to the current Directive 93/42 / EEC, with particular reference to the timing of implementation of the various provisions of the MDR starting from 26 May 2020.
ISEMED - The major impacts for manufacturers
Impacts on the quality system
UDI and EUDAMED database
TÜV SÜD Italia - The vision of the Notified Body:
New operating methods of the Notified Bodies
Certification process, highlighting what will change with respect to Directive 93/42 / EEC
Certification priorities under MDR
Co-validation of CE certificates
Times of implementation of the various provisions of the MDR
Final discussion with the participants
FREE EVENT under the "Associati per Associati" program of CONFINDUSTRIA EMILIA
When: 28-MAY-2019 from 14:30 to 17:30
Where: Panini Room - Modena Chamber of Commerce (Palazzo Molza - Via Ganaceto 134, 41121 Modena) - Google MAPS
We ask you to register for free through the contact