“Help me, I have a medical device!” – The 10 most important steps for approval for the European market. About MDR certification within EU.
The healthcare sector is booming. There are many use cases for new technologies in medical care, such as AI, medical software, high-tech implants, 3D printing and much more. As digitization has picked up speed in healthcare as well, the healthcare market has become even more interesting. But at some point, technology and software meet regulation and licensing. Many young or EU-new companies realize only late or in the middle of market access, what enormous effort is involved in the approval of a medical product.
Due to the new EU regulations, the effort for a CE marking of medical devices has increased significantly. The CE mark is a prerequisite for marketing a medical device in the EU. In particular, before a product can be placed on the market, it must be proven that it is safe and fulfills its purpose. The CE mark is also required for an application for inclusion in the Digital Health Applications (DiGA) directory.
New EU regulations MDR and IVDR
But before affixing the CE mark, it is necessary to navigate a thicket of laws, regulations, directives and standards whose requirements a product must meet. This webinar aims to provide an overview of the key steps, terms and frameworks. It is primarily aimed at start-ups and young or industry-new companies that want to bring their product idea to the healthcare market.
This webinar refers in significant parts to the two new EU regulations MDR and IVDR, which are the most important legal basis for placing medical devices on the European market. Of course, it is not intended to be a substitute for professional and individual advice.
If you want to know more, please visit our workshops or contact us directly. We are always happy to receive questions, criticism, suggestions or even proposals for updates!