mdr-745-specialist

Apply the classification rules in MDR Annex VIII based on device duration, invasiveness, and body system interaction. Software devices follow MDCG 2019-11 guidance, and borderline cases should be validated with Notified Body consultation.

MDR Annex II requires device identification and UDI-DI, intended purpose, labeling and instructions for use, risk management documentation, design and manufacturing information, and evidence of General Safety and Performance Requirements compliance.

Clinical investigations are required for Class III implantable devices per Article 61, for novel devices, and when significant changes are made. Otherwise, literature-based clinical evidence per MEDDEV 2.7/1 rev.4 may suffice.

Yes, MDR Chapter VII requires a PMS plan per Article 84 for all devices. Higher-risk classes also need Periodic Safety Update Reports, serious incident reporting, and trend analysis integrated with PMCF activities.

Literature-based evidence is insufficient for novel devices, Class III implantables, or devices with significant changes. A gap analysis determines whether existing clinical data is adequate or a clinical investigation is mandatory.