recorded on 21.03.2019
|Non-ECA Members:||EUR 199,--|
|ECA Members:||EUR 149,--|
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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.
The following issues around the new Medical Device Regulation will be addressed:
Background of the changes in medical device regulation
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“)
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)
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) .
Dr Peer Schmidt, AbbVie Deutschland GmbH & Co. KG
Peer Schmidt brings more than 15 years of experience in the development, manufacturing, registration and supervision of Medicinal Products, Medical Devices and Combination Products. As Senior Manager Global Quality Systems, he leads the AbbVie Center of Excellence for Quality Risk Management. He also acts as EU Authorized Representative and Management Representative for AbbVie´s Medical Devices. He holds a PhD in Molecular Biology and was previously the Head of Quality Assurance at Abbott Biotechnology Germany.