Regulatory Compliance

Frequently Asked Questions

Get answers to common questions about MDR and IVDR regulations for healthcare professionals

All Categories

General MDR/IVDR

Device Classification

Healthcare Professional Responsibilities

Compliance and Documentation

Implementation and Training

Post-Market Surveillance

General MDR/IVDR

4 questions in this category

Device Classification

4 questions in this category

Healthcare Professional Responsibilities

4 questions in this category

Compliance and Documentation

4 questions in this category

Implementation and Training

4 questions in this category

Post-Market Surveillance

4 questions in this category

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Frequently Asked Questions

General MDR/IVDR

What are the MDR and IVDR regulations?

How do MDR and IVDR affect healthcare professionals?

What is the difference between MDR and IVDR?

Are there transition periods for existing devices?

Device Classification

How are medical devices classified under MDR?

How are IVD devices classified under IVDR?

Who is responsible for device classification?

What happens if a device is misclassified?

Healthcare Professional Responsibilities

What are my responsibilities as a healthcare professional under MDR/IVDR?

How do I report a serious incident involving a medical device?

What should I do if I suspect a device is non-compliant?

Am I required to participate in clinical investigations?

Compliance and Documentation

What documentation should healthcare facilities maintain?

How long should we keep device-related documentation?

What is the Unique Device Identification (UDI) system?

How do I verify if a device is compliant with MDR/IVDR?

Implementation and Training

How should hospitals prepare for MDR/IVDR compliance?

What training is required for healthcare staff?

How often should training be updated?

Who should be involved in MDR/IVDR implementation?

Post-Market Surveillance

What is post-market surveillance and why is it important?

How do I stay informed about device recalls and safety alerts?

What should I do when a device recall is announced?

How do I contribute to post-market surveillance?

Still Have Questions?