Module 16 2022

02/09/2022

National Laws (Germany) Medizinproduktegesetz

“ Sicherheitsbeauftragter ” § 30 ● Needed for manufacture/authorized representative/importer into EEA, based in Germany ● Name notified to the regional Bundesländer authority ● Must collect, evaluate and report device related risks “ Risiken über Medizinprodukte ”; coordinate corrective measures ● Must have adequate training ● “Must not be disadvantaged because of his or her performance of the entrusted tasks” ● Personal liability

The Organisation for Professionals in Regulatory Affairs

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COV1

National laws (Germany) Medizinprodukte – Sicherheitsplanverordnung ● Sets out reporting requirements ● Duty to co-operate in the event of a report ● Gives competent authority enforcement and inspection powers

Medizinprodukte – Betreiberverordnung ● Recording and documentation and further notification obligations for operators and users

Sanctions ● “ Ordnungswidrigkeiten ” (fines up to € 30,000)

The Organisation for Professionals in Regulatory Affairs

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