On 14 June 2023, ECM Medical Devices Division organizes an in-depth webinar on how to deal with the extension of the MDR transitional provisions, introduced by Regulation (EU) 2023/607.

The extension of Regulation (EU) 2017/745 transitional provisions, stated in the Regulation (EU) 2023/607 of 15 March 2023, has led to important implications on both manufacturers and notified bodies. The extension of the validity of MDD certificates is actually bound to certain conditions, including that by 26/05/2024 the manufacturer has submitted the application for certification to a notified body and by 26/09/2024 a written agreement between the parties has been concluded.

ECM, as Notified Body 1282 for MDR, periodically attends international meetings with institutions, stakeholders and certification bodies to discuss regulatory updates and identify a shared approach to regulatory changes. At the latest events in which ECM participated – the Team-NB General Assembly, the 68th NBCG-Med meeting, and the RA DAY of Confindustria DM – the parties involved emphasized the importance for manufacturers to approach a Notified Body as soon as possible to start the MDR certification process.

THE ECM WEBINAR

In order to outline these important updates, on Wednesday, June 14, 2023 – 3:30 p.m. to 4:30 p.m., ECM will schedule the free live webinar “How to deal with the extension of the MDR transitional provisions”.

The ECM webinar will focus on regulatory news approached from the perspective of the notified body, including:

• requirements to benefit from extended validity of MDD certificates
• elimination of the “sell-off” date
• surveillance by notified bodies.

The speaker for the webinar is our Sales Manager of the Medical Devices Division Eng. Diego Stevanella.

At the end of the event a Q&A session is also scheduled in order to answer any questions participants may have.

For more information, please feel free to contact us at: Eng. Diego Stevanella – Sales Manager ECM diego.s@entecerma.it | (+39) 393 2471040

Download the event flyer >>