Module 16 2022

02/09/2022

National Laws (France)

R 5212 Code de la Santé Publique ● Additional voluntary notifications ● “ Correspondant de matériovigilance ” for manufacturers or authorized representative in France

Sanctions ● Imprisonment for up to 2 years and 7 years in case of risk ● Up to €150,000 fine and €150,000 fine in case of risk

The Organisation for Professionals in Regulatory Affairs

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National Laws (The Netherlands)

Besluit Medische Hulpmiddelen 1995 ● Undertaking as part of conformity assessment ● General duty to provide authorities with information needed to perform their tasks

Sanctions

● Economic crime – Imprisonment of maximum 6 months – Fine of up to €20.500 – Loss of “rights or advantages” for up to 2 years – Partial or total closure of the company for up to one year – Confiscation of goods – Supervision of the company (for maximum of two years) – Imposing obligations to comply with violated rules

The Organisation for Professionals in Regulatory Affairs

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