Webinars

MDR Delay Webinar – Do you understand the implications of this delay?

1h 20min

On the 24^th of April 2020, Regulation 2021/561 was adopted and published, delaying the MDR by 1 year to May 26^th  2021;

But what does this mean for Medical Device manufacturers?

In our MDR Delay webinar we cover the impact on:

• Notified Bodies
• Technical Documentation
• EUDAMED & UDI (Unique Device Identification)
• Vigilance & Post Marketing Surveillance
• Person Responsible for Regulatory Compliance (PRRC), Economic Operators and Liability
• Competent Authorities & Sanctions
• And more….

COVID-19 IVD Webinar: How to register test kits in Europe

32:16 min
This webinar explains the process to register IVD Covid-19 test kits in Europe.

It covers the following topics:

1. Overview of the In-Vitro Diagnostics Directive 98/79/CE: Steps to compliance and documentation required
2. Notification Process for IVDs and National Registration
3. COVID-19 Tests: types, classification, main regulatory facts

MDR delay explained (available in Hebrew)

58:41 min
This webinar explains the delay of the MDR and actions to take.

MDR impact on businesses

18:26
This webinar provides a general overview on MDR, going through the relevant timelines for manufacturers, changes in medical devices’ classification rules, new requirements for Notified Bodies and changes in Quality Management System standards that need to be followed by manufacturers.
The 72-hour access includes a download of our 200-page MDR e-book.

Introducing the new Medical Devices Regulation (MDR)

36:25
This detailed and comprehensive webinar provides an overall analysis of the main changes introduced by MDR, including relevant timelines, new requirements for Notified Bodies and Quality Management Standards, guidance on clinical evidence and clinical evaluation reports, centralisation of the notification through EUDAMED, as well as an overview of the role of the PRRC (Person Responsible for Regulatory Compliance), Authorised Representative, importers and distributors of medical devices.
The 72-hour access includes a download of our 200-page MDR e-book.