Webinar: The new Medical Device Regulation and its influence on Combination Products
Thursday, 21 March 2019 14.00 - 15.30 h
Course No. 17206
Speakers
Dr. Peer Schmidt
AbbVie
Background
In the EU, Medical Devices are regulated by two EU Directives (90/385/EEC, 93/42/ EEC) whereas in-vitro diagnostics are regulated by an independent directive. This will change in the near future. With the publication of the new Medical Devices Regulation (MDR) in the Official Journal of the European Union, a transition period has started which will end in May 2020. The MDR will supersede the two directives regarding the active implantable Medical Devices (AiMDD) and all other Medical Devices (MDD). The changes concern all classes of Medical Devices and will lead to distinct, detailed and extensive requirements. They will also apply to the Medical Device elements of Combination Products.
What do manufacturers of Medical Devices/Combination Products have to expect in the near future?
What are the crucial changes?
What has to be considered for implementation?
What should be done already now?
These questions will be clarified during the webinar.
Target Group
This training is intended for employees of enterprises who want to be informed about the requirements of the Medical Devices Regulation, especially manufacturers of Medical Devices. It also applies to drug manufacturers utilizing medical devices to administer their products (Combination Products) .
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
The following issues around the new Medical Device Regulation will be addressed:
Background of the changes in medical device regulation
Transition periods
Changes in product classification
Conformity assessment of Combination Products according to MDR
New requirements regarding technical documentation
Identification of products by means of UDI
- What is UDI
- Differences/Similarities to US requirements
The person responsible for regulatory compliance („QP for Medical Devices“)
Requirement profile
Interim solutions
Medical Devices Coordination Group (MDCG)
Scrutiny procedure for specific Medical Devices
Clinical evaluation / studies
Supervision by competent authorities
EUDAMED data base
What to consider when getting ready for the new regulations?
Compatibility of the MDR, Quality System for Medical Devices (21 CFR 820) and GMP for Combination Products (21 CFR 4)
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