Dr Peer Schmidt, AbbVie Deutschland GmbH & Co. KG
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.
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) .
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
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.
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)