EU MDR IVDR 2026 Borderline Manual Update (Version 5)

The EU MDR IVDR Borderline Manual 2026 (Version 5) provides updated guidance on borderline products and classification under Regulations (EU) 2017/745 and 2017/746. This manual helps manufacturers determine whether products qualify as medical devices or IVDs based on intended use, ensuring correct classification and smoother EU market access.

Key Updates in the 2026 Borderline Manual (Version 5)

The latest version of the manual introduces several important clarifications for manufacturers and regulatory professionals dealing with borderline products in the EU.

Expanded Borderline Examples

Version 5 includes new and refined examples covering:

• Medical devices vs. medicinal products

• Combination and hybrid products

• Products with ambiguous intended purposes

These examples provide practical insight into how authorities interpret complex classification scenarios.

Greater Clarity on Intended Use

The manual reinforces that intended use remains the primary factor in determining whether a product falls under MDR or IVDR.

Manufacturers must ensure that:

• Product claims are consistent across labeling and marketing

• The intended purpose clearly aligns with regulatory definitions

Improved Alignment with MDR and IVDR Rules

The guidance supports consistent classification across:

• MDR risk classes (Class I, IIa, IIb, III)

• IVDR classes (A, B, C, D)

This helps reduce differences in interpretation between EU Member States.

Additional Medical Device vs Medicinal Product Cases

New case studies clarify borderline decisions involving:

• Drug-device combinations

• Administration systems linked to medicinal products

• Ancillary devices

These updates are particularly relevant for innovative and combination products.

Impact on EU Market Access

The updated EU MDR IVDR Borderline Manual 2026 has direct implications for manufacturers:

• Reduced regulatory uncertainty for borderline products

• Faster classification decisions when supported by examples

• Improved consistency across notified bodies and authorities

• Lower risk of reclassification delays

Incorrect classification can still lead to compliance issues, delays, or market withdrawal, making early assessment critical.

How to Comply with the 2026 Update

To align with Version 5 of the manual, manufacturers should:

• Review product intended use statements carefully

• Benchmark against new borderline examples

• Confirm classification under MDR or IVDR rules

• Document justification for classification decisions

• Engage with notified bodies early for complex cases

Internal Resource

EU Medical Device Classification & Regulation (MDR/IVDR)

External Resource

The official EU MDR IVDR Borderline Manual 2026 (Version 5) on the European Commission website