New EU manual on borderline & classification of medical devices and IVDs
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
Purpose and scope
Classification is not always straightforward. Misclassification can create regulatory uncertainty, distort the internal market, or compromise patient safety. Therefore, the manual clarifies borderline situations and explains how to apply classification rules consistently across EU member states.
Although the manual is not legally binding, it records the consensus of national competent authorities and serves as a widely used reference in regulatory practice.
Selected cases from the 2025 edition
COVID-19 nasal spray
A nasal spray containing antibodies designed to inactivate SARS-CoV-2 is not classified as a medical device. Its principal action is immunological, which places it in the scope of medicinal products rather than devices.
Rescue bag for patient transport
Rescue bags intended to protect and stabilise patients during emergency transport are classified as Class I medical devices. Their intended purpose aligns with the MDR definition of alleviating or compensating for injury or disability.
Root canal irrigation solutions
Solutions that include antimicrobial substances (for example sodium hypochlorite or chlorhexidine) may be classified as Class III medical devices. In those cases, the antimicrobial action is considered ancillary to the device’s mechanical cleaning function.
Medical calculators
Software that computes clinical scores (for example stroke risk or kidney function) qualifies as medical device software. Depending on the clinical significance of the output, such software is typically classed as Class IIa or higher.
FeNO measuring device
Devices that measure fractional exhaled nitric oxide (FeNO) to support asthma assessment are classified as in vitro diagnostic devices (IVDR), because they analyse specimens derived from the human body.
Why this update matters
By offering clear examples and interpretation, the updated manual improves regulatory alignment across the EU. As a result, manufacturers gain greater predictability, regulatory authorities can act more consistently, and patient safety is reinforced. Moreover, clearer classification supports innovation and smoother market access.
Reference and call to action
For full details, read the official manual: Manual on Borderline and Classification for Medical Devices and IVDs – Version 4 (September 2025).
