Module 17 2024

04/12/2024

Facilitation by a Competent Authority

• Facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device (Art.10(14)) – Subject to data protection rules – Subject to IP protections – unless overriding public interest in disclosure • No obligation on Authority if disclosure obtainable ordinarily in legal proceedings

Mfr obligation to provide info, docs, samples & access to the device to demonstrate conformity (Art.10(14))

Authority considers or has reason to believe a device has caused damage

Upon request the Authority shall facilitate provision of the above info & docs to (1) potentially injured patient (2) user (3) successors in title (4) patient’s or user’s health insurer (5) other third party affected by the damage to patient or user

Revised EU PLD and draft AILD allow court to order disclosure by D of necessary & proportionate evidence (also against 3P if AIaMD for negligence claims)

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Wide-ranging transparency in MDR

Summary of Safety & Clinical Performance (SSCP) • Class IIIs & Implantables

Recital (43)

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“Transparency and adequate access to

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Clinical Investigations (CIs) • Study Reports & Lay Summaries (no PD or CCI)

information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.” (NB: future Eudamed public availability may help protect against claimant requests for disclosure orders under revised EU PLD / draft AILD)

UDI database

• No UDI-PIs or CCI to be public BUT incl processing and label info + device status

EOs database • name, contacts, role, PRRC’s name & contacts

Devices database (?) • Incl markets, materials, CIs, contract mfrs, SCCP & device status

NB certificates • Suspended, w/drawn, reinstated, refused, restrictions

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Vigilance & PMS • Appropriate public access to FSNs, serious incidents, PSURs, trend reports

TOPRA MSc Module 17

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