EU Commission’s Medical Devices Regulation Simplification Proposal and EUDAMED Mandatory Modules Timeline
Dear Clients,
This client update outlines two recent European Union regulatory developments that are particularly relevant to medical device and in vitro diagnostic (IVD) stakeholders that market, or plan to market, products in the European Union, including many Israeli healthcare companies operating cross-border through EU distributors, EU Authorized Representatives, and strategic partners.
We remain at your disposal to provide legal counsel on any matters arising from the developments described above and to assist as needed.
Agmon With Tulchinsky
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