EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.102_103_104: Confidentiality, data protection and Medical Device Coordination Group cooperation (Articles 102-104)

Article 102 imposes confidentiality on competent authorities, NBs and other persons involved, with carve-outs for cooperation between authorities + publication of data through EUDAMED (subject to confidentiality safeguards). Article 103 confirms that the GDPR + Regulation (EU) 2018/1725 apply to personal-data processing under IVDR. Article 104 establishes the funding regime for Union-level activities under the IVDR. Articles 105-108 govern the Medical Device Coordination Group (MDCG) - composed of Member State representatives + Commission, with expert panels and EU reference laboratories supporting Class D scrutiny.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

GDPR · 2 controls

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.