Borderline Manual

Navigating Product Classification in the EU: Insights from the Borderline Manual for Medical Devices and IVDs

The EU Borderline Manual helps manufacturers determine if their product qualifies as a medical device or IVD. Learn how this tool supports regulatory clarity under MDR and IVDR.

Understanding whether a product qualifies as a medical device, in vitro diagnostic (IVD), or something entirely different (e.g., a cosmetic, biocide, or food product) is a key regulatory step. The European Union has published a critical tool to assist in this complex process: the Manual on Borderline and Classification for Medical Devices and IVDs, updated most recently in September 2023.

This manual, compiled by the Borderline and Classification Working Group (BCWG) under the Medical Device Coordination Group (MDCG), helps clarify difficult cases and foster consistency in regulatory interpretation across EU Member States.

What Is the Borderline Manual?

The Borderline Manual is a non-binding but widely respected guidance document used by EU competent authorities to assess whether a product falls under the scope of the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746).

Its two primary goals are:

1. Qualification – Determining whether a product should be regulated as a medical device or IVD.

2. Classification – Assigning the correct risk class (e.g., Class I, IIa, IIb, III for medical devices; Class A-D for IVDs).

Why Is It Important for Manufacturers?

For manufacturers, especially those working with borderline products (e.g., dermal fillers, disinfection agents, apps with medical purposes), this Manual can:

Reduce regulatory uncertainty
Guide product development in compliance with EU laws
Support CE-marking strategies
Help avoid costly reclassification or non-compliance issues

Common Borderline Cases Explained

The Manual covers a wide array of borderline scenarios, such as:

Medical devices vs. cosmetics – e.g., skin treatments claiming anti-inflammatory action may fall under medicinal product rules.
Medical devices vs. biocides – e.g., antimicrobial sprays for textiles often do not qualify as medical devices.
Medical apps – software calculating diagnostic scores based on patient data is often classed as a Class IIa medical device under Rule 11.
Devices with medicinal components – irrigants with antiseptic action may be Class III if their effect goes beyond mechanical cleaning.

How to Use the Manual Effectively

Although not legally binding, the Borderline Manual reflects the consensus among EU regulators and should be used alongside other MDCG guidance (e.g., MDCG 2019-11 for software or MDCG 2022-5 for medicinal products).

When in doubt:

Consult the Manual early during development.
Assess your product’s principal mode of action (e.g., pharmacological vs. mechanical).
Document your rationale clearly in your Technical File or PIF.

AF Pharma’s Expert Support

At AF Pharma, we specialize in supporting manufacturers with the classification and qualification of medical devices, IVDs, cosmetics, and borderline products. Whether you're developing a new skincare device, a fertility diagnostic, or a smart health app, we help you determine the correct regulatory path across the EU, UK, US, and Australia.

Need help interpreting the Manual or updating your Technical File? Contact us for tailored regulatory consulting, EU Rep, UKRP, and FDA support.

Contact AF Pharma

Visit: www.afpharmaservice.com

Email: info@afpharmaservice.com