Implications of the Update to the Borderline & Classification Manual under MDR and IVDR

What’s New in Version 4

While the update does not rewrite the legislation, it adds clarification, new examples, and refined interpretation. Key growth areas in the manual include:

• More concrete case studies of borderline scenarios. These help illustrate how decisions should be made in context, especially in ambiguous cases where a product might be viewed under several regulatory regimes (e.g. medical devices vs. medicinal products, cosmetics, biocides or PPE).
• Clarification on how intended use and product characteristics interact to drive classification and qualification under MDR / IVDR Articles governing “what is a device.”
• Additional examples addressing innovative and combination products where features may overlap categories.
• Refined guidance on applying risk classification rules (Annex VIII MDR, IVDR) in edge cases. This includes more nuanced interpretation of device functionality, sterility, software, and active substances.

Why this Matters

For regulatory affairs professionals, Version 4 carries significance in several dimensions:

1. Reducing Uncertainty in Borderline Cases
   Organizations developing products at the margins—e.g. with dual-action elements, or features that could push them into a higher-risk class—will find more useful precedent in Version 4. These precedents could reduce variation in how different competent authorities or notified bodies interpret borderline devices.
2. Consistency Across EU Member States
   Harmonisation is a continuing goal under MDCG and BCWG. Better-defined examples reduce the room for divergent interpretations at the national level, which in turn helps streamline conformity assessment / regulatory strategy.
3. Impacts on Regulatory Strategy and Product Development
   Decisions about how to design a device, choose materials, define claims, or document intended use may be swayed by how the manual treats similar cases. Marketing claims that tilt a product into medicinal or cosmetic territory, or functionality that crosses into IVD scope, will need careful pre-market review in light of the new examples.
4. Notified Body and Authority Interactions
   Notified bodies and regulators may reference the manual in audits, conformity assessment, and when issuing questions. Regulatory dossiers should anticipate queries based on the examples and clarity provided in Version 4. It may alter the expectations for technical documentation, especially in borderline or combination cases.

Practical Recommendations

Regulatory affairs teams should consider the following steps in response to the update:

• Review existing product portfolio for borderline / combination products to see if reclassification risk has shifted. If a device was borderline before, check whether one of the new examples is closely analogous to it.
• Update internal classification decision trees and standard operating procedures to align with the new manual. Ensure that documentation explicitly references the new examples where relevant.
• Train staff (regulatory, R&D, marketing) on how intended use, claims, and product design can affect classification, especially as illustrated in recent cases in the manual.
• For new product development, consult the manual early when drafting claims, specifications, or design features that might trigger reclassification or cross-regulatory-regime risk.
• Maintain dialogue with Notified Bodies or Competent Authorities: include in project planning any time needed to address borderline issues, to avoid downstream surprises in conformity assessment.

Potential Challenges and Areas to Monitor

• Even with the updated manual, some borderline cases will remain ambiguous, especially for novel technologies or combination products.
• It remains necessary to interpret the manual in the specific context of the device, its intended use, the claim, and national authority practice. Regulatory risk may still arise.
• Differences in how certain Member States or Notified Bodies apply the manual may persist until case law or frequent practice builds up.
• Keeping up with related guidance (MDCG, harmonised standards, EU case law) remains essential: the manual does not replace binding law, and other regulations (e.g. medicinal products, cosmetics, biocides) may still apply depending on route of qualification.

Source: Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025