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.

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

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