The latest revision of MDCG 2021-24 Rev.1 brings several important updates to the guidance on classification of medical devices under EU MDR 2017/745.
Although the classification rules themselves remain unchanged, the revised guidance provides additional clarification, updated wording, revised examples, and further interpretation intended to support more consistent application of MDR classification requirements across the EU.
For many manufacturers, device classification was completed during the MDR transition phase and has remained unchanged since then. However, regulatory interpretation continues to evolve, and this can impact how products are assessed during technical documentation review.
Key Updates Introduced in MDCG 2021-24 Rev.1
The revised guidance includes improved interpretation of classification rules for complex and borderline products, additional practical examples to support more consistent application of MDR classification criteria, expanded clarification related to invasive and active devices, further guidance relevant to Software as a Medical Device (SaMD), updated terminology aligned with Annex VIII classification principles, and revised notes with additional practical interpretation across multiple classification rules.
One notable revision is the replacement of the term “surgical” with “clinical” in sections related to implantable devices. The updated wording now includes both surgical and non-surgical clinical procedures.
The revised guidance also includes updates related to Rules 2, 8, 9, 10, 12, 16, and 22.
Why Classification Justification Matters
From a regulatory perspective, classification affects several important areas including conformity assessment pathway, level of Notified Body involvement, clinical evidence expectations, technical documentation requirements, post-market obligations
Areas Most Likely to be Impacted
This becomes especially important for active devices, implantable products, software-related technologies, borderline products, devices with evolving intended purpose claims.
A Practical Regulatory Reminder
In many technical documentation reviews, classification rationale is one of the first areas examined by reviewers and Notified Bodies. A well-supported and updated justification can help reduce unnecessary questions and avoid delays during assessment.
The latest MDCG revision serves as a useful reminder that classification justification under EU MDR should be considered an ongoing regulatory activity. It should continue to be reviewed as regulatory interpretation, intended use, and clinical practice evolve over time.
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