#BGBl. 2026 I Nr. 20Fifth Regulation Amending the Implant Registry Operating Ordinance

This regulation, published in the German Federal Law Gazette on 27 January 2026, introduces the fifth set of amendments to the ordinance governing the operation of Germany's national implant registry. The Implantateregister-Betriebsverordnung establishes technical, data-security, and procedural rules for the mandatory registry that tracks medical implants such as joint replacements, stents, and pacemakers. The fifth amendment, issued by the Federal Ministry of Health, likely refines data reporting obligations, improves interoperability with hospital IT systems, and updates security standards for the central database. It continues the stepwise implementation of the registry that became fully operational in recent years to enhance patient safety and enable post-market surveillance of implantable medical devices.

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