EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.112_113: Penalties and entry into force (Articles 112-113)

Article 112 requires Member States to lay down penalties for infringements of the Regulation. Penalties shall be effective, proportionate and dissuasive. Member States notify the Commission of the rules. Article 113 (Entry into force and date of application): the Regulation entered into force on 25 May 2017 and applied from 26 May 2022 (subject to the Article 110 transitional provisions for legacy devices).

Other controls in IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

IVDR-Art.102_103_104 Confidentiality, data protection and Medical Device Coordination Group cooperation (Articles 102-104)
IVDR-Art.110 Transitional provisions (Article 110 as amended by (EU) 2024/1860)
IVDR-Art.78 Post-market surveillance plan and system (Article 78)
IVDR-Art.80_81 Periodic Safety Update Report (Article 80 + 81)
IVDR-Art.82_83_84_85_86 Vigilance + serious incident reporting + field safety corrective actions (Articles 82-86)
IVDR-Art.92_93_94_95 Market surveillance and Member-State competent authorities (Articles 92-95)

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MCP endpoint All EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls