mdr-745-specialist

Identify EU MDR compliance gaps by running a gap-analysis simulation that checks your device against Annex VIII classification rules, Annex II/III technical files, and Annex XIV CER/PMCF planning to surface missing documentation.

Prepare MDR technical documentation by aligning your files with Annex II/III requirements, ensuring ISO 14971 risk management and GSPR compliance are integrated, and selecting the appropriate conformity assessment route for your device risk class.

EUDAMED registration is a core component of EU MDR compliance planning, requiring UDI readiness and proper device classification under Annex VIII before completing the registration workflow for your specific medical device.

Yes, the MDR gap analysis applies classification patterns and conformity routes across Class IIa, IIb, and III devices, checking ISO 13485 quality management and post-market surveillance alignment for Notified Body submissions.

You need a PMCF plan under EU MDR Annex XIV when updating your Clinical Evaluation Report (CER), requiring post-market surveillance activities to confirm clinical safety and performance throughout the device lifecycle.

MDR compliance requires ISO 14971 for risk management and ISO 13485 for quality management to satisfy General Safety and Performance Requirements (GSPR) and ensure technical documentation meets Annex II/III standards.