Overview

The regulatory environment for medical devices in Europe is changing. With an increased focus on patient safety, the European Medical Device Regulation (MDR) has introduced new requirements and processes.

This training provides insights into the MDR and the practical implications for manufacturers and decision makers likewise. The course is designed to guide through the main challenges including classification and the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies. In interactive practical exercises participants will gain understanding of product demarcation, classification and the need of an integrated pathway for Drug-Device Combination (DDC) products.

Delegates will have the opportunity to discuss the complexities involved with experts who have huge knowledge and experience in this field.

Featured topics

Background, Objectives and Key Elements of the MDR
Medical Device Coordination Group (MDCG)
Demarcation and Classification of Medical Devices
Software as Medical Device
General Safety and Performance Requirements (GSPR)
Post-Market Surveillance and Vigilance
Drug-Device Combination Products
Clinical Evaluation and Clinical Investigations

Who should attend?

This course is designed for participants working in Regulatory Affairs for medical devices and medicinal products in departments of:

Pharmacovigilance
Quality Assurance
Clinical Development
Technical Support

This course will be of particular interest to all personnel who either are new to the medical device issues or have been working under the “old” system from industry as well as from decision making perspective.

Learning objectives

Gain a comprehensive understanding of the new requirements of the MDR and realise the major changes incl. Vigilance and Post-Market Surveillance
Learn the demarcation process and classification of medical devices according to risk classes
Understand how risk should be managed
Recognise the different stakeholders involved, besides the Notified Bodies
Consider the challenges and opportunities of Drug-Device Combination products

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
Mac OS X: 10.5, 10.6, 10.7
Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
Mac OS X: Intel processor, At least 512 MB RAM
Linux: At least 512 MB RAM

Display

800x600 pixel resolution or greater (1024x768 pixels recommended)

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Medical Devices and Drug-Device Combination Products in the European Union