EU 2025 Guidance on Borderline and Classification of Medical Devices

The European Commission has issued its 2025 Guidance on Borderline and Classification of Medical Devices under MDR (EU 2017/745) and IVDR (EU 2017/746). This update clarifies risk classes for borderline devices, including SARS-CoV-2 tests, and provides guidance for manufacturers on classification, electronic Instructions for Use (eIFU), and revised preliminary assessment review (PAR) forms. Understanding these classifications is essential for compliant market access and aligning with the latest EU regulatory requirements.

Key Updates in the EU 2025 Guidance

1. Reclassification of SARS-CoV-2 Tests

• Most SARS-CoV-2 diagnostic tests moved from Class D to Class B.

• Self-tests are now Class C, reflecting higher risk for unsupervised use.

2. Electronic Instructions for Use (eIFU)

• New rules allow electronic IFUs, improving accessibility and compliance.

3. Revised Preliminary Assessment Review (PAR) Forms

• Updated templates streamline IVDR evaluation and harmonize regulatory submissions across EU member states.

Impact on Market Access and Compliance

• Clarifies borderline device rules, reducing uncertainty for manufacturers.

• Facilitates faster EU market access with consistent guidance on classification.

• Supports adoption of digital tools like eIFU, enhancing user safety and sustainability.

How Manufacturers Can Comply

1. Review device classification using the updated MDCG 2020-16 (March 2025) guidance.

2. Update technical documentation to reflect risk class changes.

3. Use the revised PAR form template for IVDR submissions.

4. Implement electronic IFUs where applicable, following the amended eIFU regulation.

Internal links:

• Learn more about EU Medical Device Classification & Regulation (MDR/IVDR)

• Explore EU IVDR Classification

External links:

• Official EU Guidance: European Commission Update – September 2025

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