Module 16 2024

23/10/2024

National Laws (France)

Sanctions (Article L. 5461-2 CSP)

● Failure to report Serious Incidents (Art. L. 5461-2 § I CSP); ● Failure to immediately inform of Serious Risks (Art. L. 5461-2 § II CSP); ● Failure to report a FSCM (Art. L. 5461-2 § III CSP);

Is punishable by a criminal sanction: – Imprisonment for up to 2 years – Up to €150,000 fine (€750,000 for legal entities) The ANSM may also impose financial penalties (Article L. 5461-9 CSP).

The Organisation for Professionals in Regulatory Affairs

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National Laws (Germany)

Medizinprodukterecht-Durchführungsgesetz – MPDG ● Criminal or monetary sanctions for breach of MDR/IVDR device vigilance obligations are very limited in Germany ● Primarily addressed by regulatory enforcement measures in the MPDG (Medizinprodukterecht-Durchführungsgesetz), which governs the national implementation of the MDR / IVDR – § 78 (1) MPDG: ‘ The competent authority shall take the measures necessary to eliminate any infringement and to prevent any future infringements [of MD law].’ – Measures must me proportionate and may include prohibiting or restricting the placing on the market / making available, recalling or seizing the device concerned, and even the closure of the business ● Anyone who does not permit or support the monitoring by the regulatory authority commits an administrative offence ( Ordnungswidrigkeiten ) and may be subject to a fine of up to EUR 30,000

The Organisation for Professionals in Regulatory Affairs

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