mdr-745-specialist_skill

Overview

This skill is an EU MDR 2017/745 specialist and consultant focused on practical regulatory requirement management for medical devices. It delivers expert MDR classification, gap analysis, technical documentation guidance, clinical evidence planning, UDI implementation, and post-market surveillance support. Use it to align products and processes with MDR obligations and prepare for Notified Body engagement.

How this skill works

I inspect device characteristics, existing technical files, clinical data and QMS elements to identify compliance gaps versus MDR Annexes II, III, VIII and XIV. I map findings to required conformity assessment routes, recommend documentation and clinical evidence strategies, and provide stepwise transition plans. I also support UDI/EUDAMED setup, PMS system design and Notified Body preparation.

When to use it

• Preparing technical documentation for a new device under MDR
• Assessing legacy devices for transition from MDD/AIMDD to MDR
• Determining device classification and conformity assessment route
• Designing or updating clinical evaluation and PMCF plans
• Implementing UDI and EUDAMED registration workflows
• Preparing for a Notified Body audit or certificate renewal

Best practices

• Start classification and risk assessment early and document rationale per Annex VIII
• Use structured gap analysis tied to MDR articles and Annexes for clear remediation plans
• Prioritize clinical evidence gaps: leverage systematic literature first, then plan investigations if needed
• Integrate PMS/PMCF outputs into design and risk management to demonstrate continuous compliance
• Engage a Notified Body early for borderline or high-risk devices and validate classification decisions
• Assign a qualified person responsible for regulatory compliance and align economic operator roles

Example use cases

• Run a full MDR gap analysis for a CE-marked device to identify documentation and clinical evidence shortfalls
• Prepare an Annex II/III technical file and templates tailored to device variants and UDI-DI assignments
• Design a PMCF plan and PMCF evaluation report for Class IIb implantable devices
• Select and prepare for a Notified Body submission for a Class III implantable product
• Implement UDI strategy and map EUDAMED registration steps for manufacturers and authorized representatives