Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 12

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 12
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 Universitaire d’Angers, France (CHU Angers).    ·In 2021, we entered into clinical evaluation agreements with Inselspital University Hospital in Bern, Switzerland, and King’s College Hospital - London, in the United Kingdom.    ·In 2024, we entered into a clinical evaluation agreement for a post-CE Mark study with Ludwig-Maximilians-Universität München in Munich Germany.

EU Market Access (CE Mark)

The first TAEUS application we intend to commercialize is our MASLD TAEUS application. Our initial target market for this application is the European Union. 

After receiving CE mark approval for our TAEUS Liver system in March 2020, indicating that the TAEUS Liver system complies with all applicable European Directives and Regulations in the European Union (“EU”) and other CE mark geographies, we registered the product in each of our primary target European markets (i.e., Germany, France, and the United Kingdom). 

In May 2021, Regulation (EU)2017/745 on medical devices (the “Medical Device Regulation” or “MDR”) came into effect. The MDR amended the prior existing regulatory framework in the EU and imposed significant additional obligations on medical device-related companies. Changes imposed by the MDR include more restrictive requirements for clinical evidence and pre-market assessment of safety and performance, revised classifications to indicate risk levels, stricter requirements for third party testing by government accredited groups for some types of medical devices, and tightened and streamlined quality management system assessment procedures, including post marketing surveillance obligations. These new rules also impose additional requirements on our business, such as a requirement to conduct clinical trials to maintain our existing and obtain new or renewed conformity assessment certification for existing and new products. Also, the MDR provides for additional post-market surveillance obligations, and further requirements for the traceability of products, transparency, refined responsibilities for economic operators (including manufacturer, distributors and importers) as well as a tightened and more comprehensive quality management system.

Our original CE Mark certification, which has been issued under the then applicable framework of the Medical Device Directive, requires re-certification under the MDR in order to continue marketing of the application in the EU. The transitional provisions of the MDR are to expire on December 31, 2028 for Class I, Class IIa and certain Class IIb devices (which includes ENDRA’s Class IIa device) subject to certain conditions (including, among others, continued compliance with the MDD,