Regulatory Framework and Guidance for Medical Devices in Denmark

1. EU Regulations

The core legislation consists of two EU regulations directly applicable in Denmark:

• Regulation (EU) 2017/745 on medical devices (MDR), amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), repealing Directive 98/79/EC and Commission Decision 2010/227/EU. These cover classification, conformity assessment, clinical investigations/performance studies, and market surveillance. Source: Danish Medicines Agency Legislation and Guidance Page https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/

2. Danish National Legislation

Denmark implements these via:

• The Danish Act on Medical Devices, a framework act authorising the Minister for Health to issue executive orders.
• Executive orders transposing EU rules into Danish law, including the executive order on medical devices and in vitro diagnostic medical devices. Additional acts, executive orders, and circulars apply as compiled by the Agency. Source: Danish Medicines Agency Legislation and Guidance Page https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/

3. Guidance Documents

Guidance includes:

• MDCG-endorsed documents from the European Commission, developed with authorities, scientific societies, and industry.
• Danish Medicines Agency-specific guidance for interpreting requirements.
• List of harmonised standards providing methods to document conformity with essential safety and performance requirements. Source: Danish Medicines Agency Legislation and Guidance Page https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/

4. Key Areas Covered

The framework addresses:

• Classification of devices.
• Conformity assessment procedures.
• Clinical investigations (MDR) and performance studies (IVDR).
• Market surveillance, including incident reporting and vigilance. General requirements mandate CE marking, risk management, and post-market surveillance. Source: Danish Medicines Agency Legislation and Guidance Page https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/

5. Updates

The page was last updated on 02 February 2023. Legislation evolves through ongoing EU collaboration. Source: Danish Medicines Agency Legislation and Guidance Page https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/