Version 2 – Manual on borderline and classification for medical devices under Regulations (EU) 2017/745 and (UE) 2017/746

The working group on “Borderline and Classification” has just made available on the European Commission website the 2^nd version of the Manual of qualification of borderline products and their classification under Regulations (EU) 2017/745 and (EU) 2017/746.

As a reminder, this Manual aims to rule on the qualification of certain borderline products such as oxide gas cartridges, dermal fillers, virucidal nasal sprays… that can meet the definition of:

• Medical devices,
• In vitro diagnostic medical devices,
• Medicines,
• Cosmetics,
• Biocides…

It also specifies, as appropriate, the classification rules applicable to medical devices or in vitro diagnostic medical devices.

This new version integrates the qualification of two other products: needle counters and medical calculators.

This Manual supplements MDCG 2022-5 and MDCG 2019-11.

DOWNLOAD THE MANUAL (VERSION 2)