Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required.
The MDCG guidance on the classification of medical devices has recently been updated. First published in 2021, this document was developed to support manufacturers in correctly applying classification rules under the MDR.
The latest revision introduces additional practical examples, clarifying how specific devices align with particular classification rules and their respective indents. This added detail helps manufacturers more confidently determine the appropriate classification for their products.
The updates in this revision can be seen below;
- Section 2.1 General requirements – Updated
- Section 3.1.4 Invasiveness – Implantable devices Word ‘surgical’ was replaced with ‘clinical’ Definition updated
- Section 3.2 Application of the classification rules Word ‘device’ was replaced with ‘product’
- Section 4.1.3 Active devices – Rule 9 Structure changed to better match the rule
- Rule 2 – Table Updated
- Rule 8 – Table Updated
- Rule 8 – Practical issues of classification Updated – new notes added (1-7)
- Rule 9 – Practical issues of classification Updated
- Rule 10 – Table Updated
- Rule 10 – Practical issues of classification Updated
- Rule 12 – Table Updated
- Rule 16 – Table Updated
- Rule 22 – Table Updated
- Rule 22 – Practical issues of classification Updated – new note added
The updated guidance document can be accessed using the following link
