Germany s Digital Medical Device Regulations: A Framework For The World To Follow, Part I
Germany’s Digital Healthcare Act came into effect on December 19, 2019, introducing the “app on prescription” as part of healthcare provided to patients through digital health applications (in German: “digitale Gesundheitsanwendungen,” hereinafter DiGA). The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, or the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for DiGA manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. I will give an overview of the situation and will cover the many privacy requirements noted in the new guide in
ACell Announces CE Mark Approval
Milestone Paves the Way for MicroMatrix and Cytal Wound Management Devices in European Union
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COLUMBIA, Md., Dec. 22, 2020 /PRNewswire/ ACell, Inc., a leading regenerative medicine company, announced today that it has received CE mark approval for its MicroMatrix®, Cytal® Wound Matrix, and Cytal® Burn Matrix devices. This regulatory approval allows ACell to distribute these products throughout the 27 countries of the European Union.
President and CEO Patrick McBrayer said, The CE Mark approval is a significant accomplishment for ACell, which required rigorous regulatory review against stringent safety and clinical standards. We are proud to be one step further to offering our wound management products to patients and their health care providers throughout Europe.
December 15, 2020
- CA US
Compliance4All
Phone:8004479407
Overview:
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
It includes specific insights from direct involvement and work within the EU and the Commission s major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.