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Germany · Regulation · Rechtsverordnung

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Ordinance recasting the Medical Device Operator Ordinance and amending the Medical Device Dispensing Ordinance

openGermany· Bundesrat· DE

Introduced

23 May 2024

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Source updated

19 February 2025

Summary

Issuance of a regulation on the operation and use of medical devices (Medical Device Operator Ordinance - MPBetreibV), amendment of the Medical Devices Dispensing Ordinance;<br /> New version of the Medical Device Operator Ordinance, expansion of the respective areas of application, reduction of the documentation and testing effort for low-risk products, introduction of testing procedures for products in the form of software with increased Risk potential, lifting of the distribution restrictions for in-vitro diagnostics

Machine translation from German. The official text remains authoritative.

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6 official files

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