In September 2025, version 4 of the MDCG Borderline Manual was published. It provides guidance on products on the borderline between MDR and other legislation (e.g. medicinal products, biocides, cosmetics).

Why is it important?

Qualification as a medical device has far-reaching consequences:

  • defines the conformity assessment route,
  • determines the scope of technical documentation,
  • dictates whether a clinical evaluation (MDR art. 61, Annex XIV) is required,
  • identifies whether the product falls under a Notified Body or another regulator.

A wrong decision can delay market entry or even lead to product withdrawal.

New borderline examples

The 2025 edition introduces new case studies:

  • a SARS-CoV-2 neutralising antibody spray – borderline between medicinal product and preventive device,
  • a graphite crucible used in imaging diagnostics – device vs accessory discussion,
  • mobile diagnostic apps – lifestyle software vs Medical Device Software (MDSW).

Each case is explained with reference to MDR Article 2 definitions.

Use of MDR Annex VIII rules
The manual applies Annex VIII MDR classification rules:

  • Rule 11 (software) illustrated with detailed examples,
  • new clarifications for dentistry and dermatology products, including those with nanomaterials,
  • further guidance for Annex XVI non-medical purpose devices, e.g. cosmetic contact lenses.

Impact on stakeholders

  • Manufacturers – guidance reduces regulatory strategy risks,
  • Notified Bodies – harmonised interpretation across Member States,
  • Competent Authorities – reference tool for dispute resolution.

Borderline with other frameworks

The manual discusses cases between:

  • medicinal products vs medical devices (e.g. irrigation solutions),
  • cosmetics vs medical devices (e.g. creams for atopic dermatitis),
  • biocides vs medical devices (e.g. disinfectants for medical surfaces).

The decisive criterion remains the principal mode of action: pharmacological = medicinal product, mechanical = device.

Recommendations for industry

Manufacturers should:

  • document qualification analysis at the design stage,
  • integrate results into Annex II MDR technical documentation,
  • consult Notified Bodies/Authorities in case of doubt,
  • monitor future manual updates.

Conclusion

The Borderline Manual 2025 strengthens consistency across the EU. It is a non-binding but indispensable tool that accelerates conformity assessment and reduces regulatory risks. Most importantly, it supports MDR’s primary objective: ensuring patient and user safety through correct qualification and classification.