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February 2, 2026
Approximately 5 minutes
Key Changes to IVD Regulation in Denmark under EU IVDR
Key Changes to IVD Regulation in Denmark under EU IVDR
1. Overview and Application
The EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied since 26 May 2022, replacing Directive 98/79/EC. It introduces new and amended requirements to strengthen safety through increased clinical evidence, market surveillance, and conformity assessments. As a directly applicable regulation, it ensures uniform implementation across EU markets, including Denmark. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
2. New Risk-Based Classification
IVDR introduces a risk-based system with four classes (A lowest risk to D highest). Previously 'general IVDs' may now be classified as medium or high risk (B, C, or D). All new IVDs must follow this classification. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
3. Increased Role of Notified Bodies
IVDs in classes B, C, and D require certification by a notified body for CE marking. This significantly expands the number of IVDs needing notified body involvement compared to the previous directive. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
4. Requirements for Manufacturers
Manufacturers must conduct clinical and performance evaluations to demonstrate that benefits outweigh risks and the device meets its intended purpose. Additional obligations include EUDAMED registration, enhanced vigilance (systematic data collection and analysis throughout the device lifetime), and proactive performance monitoring. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
5. In-House IVDs
IVDs manufactured and used only within health institutions (in-house IVDs) are exempt from most IVDR requirements under Article 5(5), provided they meet Annex I safety and performance criteria and all conditions of the article. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
6. Transitional Provisions
Article 110 transitional provisions have been extended to address notified body capacity issues, ensuring continued availability of safe IVDs during the transition. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
7. Further Guidance
Additional resources include MDCG guidance on classification and performance studies. Source: Danish Medicines Agency IVDR Changes Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/changes-as-a-result-of-the-eu-regulation-on-in-vitro-diagnostic-medical-devices/
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