Module 16 2022

02/09/2022

Penalties for Breach of MDR/IVDR Requirements

Enforcement a national competency

Member States required to put in place “ effective, proportionate and dissuasive penalties ”

Focus will be in Member State where manufacturer or authorized representative is established

Both corporate and individual liability is possible ● Personal liability will focus on PRRC

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US Reporting Requirements Extensive US reporting requirements ● Domestic and foreign events ● Low causality threshold – “…whenever there is information that reasonably suggests that a device may have caused or contributed to death or serious injury…” ● Per se rule ● U.S. companies and non-U.S. multinationals in same position ● No exemptions ● Historically, exemptions in MEDDEV guidance meant far more events reportable to FDA than in Europe – Protection against a fault functioned correctly (Section 5.1.3.4, EU guidelines) – Serious injury that is an expected side effect and acceptable under risk assessment (Section 5.1.3.5, EU guidelines) ● Now only exemption is for “expected” incidents listed in IFU, subject to MDCG vigilance guidance

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