Bioexcelife
Many manufacturers assume device classification is settled once the first rationale is written.
That assumption can become risky.
In April 2026, the Medical Device Coordination Group published MDCG 2021-24 Rev.1, updating its guidance on the classification of medical devices under EU MDR 2017/745. The revision is meant to support more consistent interpretation of classification rules across the EU and includes updates to several important sections, notes, tables, and examples.
At first glance, this may look like a routine guidance refresh. In practice, it can affect how manufacturers justify classification, especially for products that sit close to the border between classes.
Why this update matters more than it seems
Under EU MDR, classification is not just an administrative label. It influences the conformity assessment route, the level of clinical evidence expected, and whether Notified Body involvement becomes necessary. The MDCG guidance exists to help stakeholders apply the classification rules in Annex VIII of the MDR more consistently.
That is why even a wording change in guidance can have real regulatory consequences.
The wording change that could widen interpretation
One of the most important revisions appears in section 3.1.4 on invasiveness for implantable devices, where the word “surgical” has been replaced with “clinical.” The revised text explains that a “clinical procedure” now covers both surgical and non-surgical procedures.
This is not a cosmetic edit. It broadens the lens through which invasiveness may be interpreted. For some manufacturers, that could mean revisiting classification logic for products used in procedures that are not strictly surgical but still involve clinical intervention.
A subtle terminology shift with wider meaning
Another update appears in section 3.2 on application of the classification rules, where the term “device” has been replaced with “product.”
That small change matters because it suggests a broader and more practical approach to interpretation. It may be especially relevant for manufacturers dealing with borderline products, novel technologies, or products that do not fit neatly into older regulatory thinking.
Rule 9 gets a structural refresh
The revision also updates the structure of section 4.1.3 for active devices under Rule 9 so that it better matches the rule itself.
For manufacturers of active therapeutic or diagnostic products, that means the guidance is becoming more explicit. And when guidance becomes more explicit, reviewers usually expect manufacturers to be more precise in their justification too.
The rules that deserve a second look
This revision does not stop at terminology. According to the updated document, the tables and practical guidance for Rules 2, 8, 9, 10, 12, 16, and 22 have been updated, and some of those sections now include additional notes and examples.
That is important because examples often shape real-world classification decisions. A manufacturer may believe its classification rationale is still valid, but if the new examples point in another direction, the Notified Body may challenge that reasoning.
What manufacturers should do now
This update sends a simple message: do not treat classification as frozen.
If your product falls under one of the updated rules, this is the right time to review the classification rationale, compare it against the revised examples, and check whether your technical documentation still tells a defensible story. Waiting until a reviewer raises the issue can create delays that are much harder to fix later.
The manufacturers who move quickly on guidance updates usually protect timelines better. The ones who rely on old interpretations often end up rewriting core justifications during review.
Why this matters for market access
Classification sits at the center of MDR strategy. When it shifts, everything around it can shift too. Clinical evidence expectations may change. The conformity assessment path may become more complex. Review time may increase. In some cases, a product that once looked straightforward can suddenly require a deeper regulatory strategy.
That is why this MDCG revision matters. It is not just about wording. It is about how the EU wants classification to be understood going forward.
MDCG 2021-24 Rev.1 is a reminder that under EU MDR, interpretation evolves continuously. Manufacturers cannot rely only on past experience. They need to keep checking whether their current classification logic still fits the latest regulatory thinking.
A strong classification rationale does more than satisfy a rule. It protects the entire submission.
How Bioexcel can help
At Bioexcel, we support manufacturers with MDR classification strategy, rationale review, and technical documentation alignment. If your product falls under one of the revised rules, this is the right moment to reassess your position before questions arise during review.
