MDCG 2021-24 Rev.1 – first update in four years
21 April 2026
In April 2026, the Medical Device Coordination Group (MDCG) published the first revision of its flagship classification guidance, MDCG 2021-24 Rev.1, marking the first revision in over four years. Although the guidance remains non‑binding, its updates are likely to shape conformity assessments and dossier reviews conducted by notified bodies and competent authorities across the EU. Therefore, manufacturers and stakeholders should take note.
This revision provides further clarity and practical examples to support the consistent application of classification rules throughout the EU.
The guidance reflects the MDCG’s position and is intended to help the stakeholders correctly apply the regulatory framework.
Key changes
The most significant change is a shift in definition in section 3.1.4: the term “surgical procedure” has been replaced with “clinical procedure” in the implantable/invasiveness wording. By explicitly covering both surgical and non‑surgical clinical interventions, the revision broadens the situations in which devices introduced into the body may be considered implantable, with potential reclassification implications for devices introduced by endoscopic, percutaneous or other non‑surgical techniques. Section 3.2 likewise replaces “device” with “product,” signalling clearer applicability to non‑medical‑purpose products in Annex XVI and affecting borderline cases.
Several rules have been revised or clarified. Rule 2 appears to have mainly presentational edits. Rule 8 gains two practical notes: one clarifies that the Article 52(4) list (sutures, staples, screws, pins, clips and similar devices) does not automatically confer Class IIb status and that each item must still be assessed under the Annex VIII rules; the other confirms that “spinal column contact” includes any bony structure of the column and treats hooks that fix rods to the spine similarly to screws and plates covered by the exemption. Rule 9 has been restructured for closer alignment with the rule text, and tables and practical‑issues sections have been updated across Rules 10, 12, 16 and 22.
Further caution advisable
The guidance still lists example devices whose characteristics are not fully explained, leaving room for divergent interpretations by notified bodies and manufacturers.
Rule 5 in particular continues to be a source of debate: devices that are partially introduced by clinical intervention and intended to remain in place for 30 days or more meet the MDR’s implantable definition, yet examples provided in the guidance may not consistently reflect this.
Our advice
Companies should re‑run classification assessments against Rev.1 as. reclassification can change conformity assessment routes, clinical evidence expectations and timelines. Technical files, risk management, clinical evaluation and PMS/PMCF plans should therefore be updated. It is also advisable to engage your notified body early on in borderline cases.
In conclusion
While Rev.1 brings welcome updates after a long pause, it does not eliminate the need for case‑by‑case judgment and proactive dialogue with regulators. Manufacturers seeking to manage risk should consider targeted reviews, pre‑submission meetings with notified bodies, or seeking formal NB positions on contentious classifications in order to avoid surprises later in the conformity assessment process.
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