Germany
5 articles
EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations
How the EU REACH PFAS restriction affects medical device components, key transition timelines (5- and 12-year derogations), concentration limits, and substitution roadmaps.
Germany Medical Device Distributor Landscape & Market-Entry Selection (2026)
A data-driven analysis of the German medical device distributor landscape based on the BVMed registry, detailing role types, product categories, and selection strategies.
Abbott FDA Device Footprint: Diagnostics, Recalls & PMA Portfolio
A data-driven regulatory profile of Abbott's FDA clearances, PMA approvals, safety recalls, diagnostics division, and global manufacturing hubs in Illinois, California, Germany, and the Netherlands.
Siemens Healthineers FDA Footprint: 510(k), PMA & Recalls Guide
A comprehensive, data-driven regulatory dossier analyzing Siemens Healthineers' FDA 510(k) clearances, PMA approvals, recalls, and global manufacturing footprint.
Germany Medical Device Registration and Market Access Guide 2026
Market medical devices in Germany with EU MDR, BfArM, PEI, MPDG, EUDAMED, DMIDS, German labeling, clinical investigations, and DiGA strategy.