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MDR/IVDR Training

Real-World MDR/IVDR Challenges

The compliance problems nobody talks about — in your department, right now

These aren't textbook scenarios. These are the 12 pain points we hear about repeatedly from ward nurses, clinical engineers, procurement officers, lab managers, and risk leads across Irish hospitals. Each one maps to specific MDR/IVDR obligations — and each has practical training content to help you close the gap.

12
Pain Points
Across 5 departments
5
Departments
Ward to governance
3
Critical
Patient safety risks
11
Modules
Linked training

Department Coverage

Ward / Nursing

3pain points3 critical
  • "Nobody told me that device was recalled"
  • "I didn't know I had to report that"
  • Single-use devices being reused quietly

Clinical Engineering

3pain points
  • No EUDAMED check at procurement
  • Legacy device end-of-life and MDR transition chaos
  • Article 5(5) in-house device accountability gap

Procurement

2pain points
  • Buying devices with no CE certificate check
  • National tender delays leaving compliance gaps

Laboratory

2pain points
  • Lab-developed tests and IVDR Article 5(5)
  • IVD transition deadline confusion

Risk / Governance

2pain points
  • No hospital-wide MDR compliance owner
  • AI diagnostic tools arriving with no governance framework

MDR/IVDR Briefing

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