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On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant interpretative clarifications for the classification of Medical Devices under the MDR (EU) 2017/745 framework, with a particular focus on implantable devices, defibrillator accessories, active devices, and sterilizers. The goal is to promote a more uniform interpretation of the MDR by manufacturers and Notified Bodies.
From Surgical Procedure to Clinical Procedure
The term “surgical” has been replaced with “clinical.” The guidance clarifies that the notion of clinical procedure includes both surgical and non-surgical interventions. In this context:
- Devices introduced via non-surgical techniques, such as cannulas, catheters, or needles, fall under the concept of an implant.
- The 30-day criterion provided by the MDR remains decisive: a device introduced partially or totally for at least 30 days within a clinical procedure is considered implantable, even in the absence of a traditional incision.
In summary, the qualification as an “implantable device” cannot be excluded solely because the device is not introduced through a traditional surgical procedure.
Rule 8 and New Clarifications
Rule 8 of Annex VIII of MDR (EU) 2017/745 governs implantable and long-term invasive devices. Generally, these devices are classified as Class IIb but may fall into Class III when intended for contact with the heart, the central nervous system, or the central circulatory system.
Revision 1 increases the practical notes for Rule 8 from five to seven, introducing key operational clarifications:
- The exemption provided by Article 52, paragraph 4 of the MDR, for certain Class IIb devices (such as sutures, staples, screws, plates, etc.) concerns the conformity assessment path and does not determine the device’s class.
- Classification remains anchored to the applicable rules of Annex VIII and the product’s intended purpose.
- The concept of contact with the spine is extended to all the bony structures that make it up, from the cervical region to the coccyx, including the spinous and transverse processes. This clarification is also relevant for spinal hooks and similar devices, as it supports a broad anatomical interpretation of Rule 8, consistent with the logic of the rule and with the exceptions already provided for certain categories of implantable devices.
Rule 10 and Active Devices
Revision 1 updates the section on active devices with new examples in Rule 10 and a reorganized text to clarify the relationship between device function and classification. Notably:
- Updated examples include ophthalmoscopes, which the guidance categorizes as active devices with a specific diagnostic or observation function.
- The focus is on making the application criteria of the rule more readable in relation to the product’s intended purpose.
Rule 16 and Sterilizers
Another clarification concerns Rule 16, which in Revision 1 confirms the classification in Class IIa for sterilizers intended to sterilize Medical Devices in a medical environment, whether invasive or non-invasive. In particolar:
- Class IIa continues to apply to sterilizers used in a medical environment.
- Clarification serves to better delimit the scope of the rule.
- The aim is to reduce interpretative uncertainty in the classification of sterilizers used in healthcare facilities or similar settings.
Other Technical Updates
- Defibrillator Accessories (Rule 22): distinction between accessories integrated into the system and those placed separately on the market, which may fall under Rule 9 or Rule 1.
- Active Devices: new application examples for Rule 10 and updates for Rule 12.
- Terminology (Section 3.2): systematic replacement of the term “device” with “product” for alignment with Regulation (EU) 2017/745.
Conclusions
MDCG 2021-24 Revision 1 is a pivotal update for the medical device sector. Manufacturers must reassess their device classifications in light of these changes, verifying the impact on technical documentation and conformity assessment procedures.
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