EU Classification Guidance Updated: Borderline Manual and MDCG 2021-24 

The European Commission published two closely related guidance updates that directly affect how medical devices and in vitro diagnostic medical devices are qualified and classified under EU MDR and IVDR. The Borderline and Classification Manual has been updated to Version 5, and MDCG 2021-24, Guidance on classification of medical devices, has been revised to Rev.1.  

Insights on the Updated EU Guidance

It is important to note that these are not minor administrative updates. Version 5 of the Borderline and Classification Manual adds new product rulings agreed by national competent authorities through the Helsinki Procedure — a voluntary mechanism under which EU Member States submit product cases for multilateral review when there is genuine regulatory uncertainty. While not legally binding, the resulting agreements represent the closest thing to authoritative guidance on borderline and classification questions outside of a court ruling. New entries span multiple borderline categories, confirm Class III classification for several substance-containing devices, broaden the definition of ‘implantable device’ by replacing ‘surgical’ with ‘clinical’ intervention, and add targeted practical notes for Rules 8 and 22 that resolve previously ambiguous classification questions. 

MDCG 2021-24 is the EU Medical Device Coordination Group’s (MDCG’s) primary guidance on how to apply the 22 classification rules in MDR Annex VIII. Rev.1 is the first substantive revision since the original 2021 publication and includes both structural changes and targeted updates to specific classification rules, definitions, and practical guidance notes.

Together, these documents clarify where the EU stands on several contested product categories, close interpretive gaps that have led to inconsistent outcomes across the market, and in several cases shift or confirm positions in ways that may affect existing technical documentation.

Key Updates in Borderline and Classification Manual

Borderline Between Medical Devices and Medicinal Products

Several new cases address one of the most consequential borderline questions under the MDR: when does a product fall under medicinal product regulation rather than the MDR? The consistent position across each new ruling is that the mode of action determines regulatory status, irrespective of product labeling and device claims.

• Menthol/capsaicin pain relief cream — ruled not a medical device. Both substances act via pharmacological means. The manufacturer bears the burden of providing scientific evidence to demonstrate otherwise. 

• Lactose vaginal tablets (bacterial vaginosis) — not a medical device. Lactose acts via metabolic means on indigenous lactic acid bacteria, which are considered part of the human body per MDCG 2022-5. 

• Bovine colostrum nasal spray (COVID-19) — not a medical device. The principal mode of action is immunological: antibodies bind to and inactivate the virus. 

• Root canal irrigation solutions (NaOCl / CHX) — confirmed Class III under Rule 14. Unless the manufacturer can provide robust scientific evidence that the substance has no antibacterial or antiseptic action in or on the human body, Class III classification applies.

• Red blood cell additive solutions containing adenine — confirmed Class III under Rule 14. Adenine was found to have a metabolic, and potentially pharmacological, mode of action ancillary to the device.

Borderline With Other Product Categories 

The manual also settles a number of cases involving other regulatory frameworks, providing clarity on where the MDR boundary sits relative to personal protective equipment, cosmetics, and medicinal product packaging. 

• Medical examination table covers — qualify as medical devices. Preventing infectious disease transmission between patients via a shared surface, constitutes a specific medical purpose under MDR Article 2(1). Material composition does not affect this conclusion. 

• Needle counters (operating room) — not medical devices. Counting and disposing of suture needles and scalpels does not constitute a specific medical purpose. 

• Plexiglas intubation protection box — not a medical device. A medical device must be aimed at protecting or benefiting the patient, not the healthcare professional. 

• Rectal laxative packaging tube — qualifies as a medical device (invasive via body orifice). Governed by Directive 2001/83/EC as a single integral non-reusable product, but the device part must satisfy MDR Annex I and be documented in the marketing authorization dossier per Article 117 MDR. 

New Classification Cases 

Version 5 also adds several agreed classification positions for products where the applicable rule or risk class has been disputed: 

• Penis holster (urinary incontinence) — Class I under Rule 1. The inner mucosa of the prepuce is not a body orifice under the MDR definition; the device is non-invasive. 

• Syringe with glass beads (autologous conditioned serum) — Class IIb under Rule 3. The device modifies the biological and chemical composition of blood intended for re-administration. The simple filtration or centrifugation exception under Rule 3 does not apply. 

• Root canal irrigation needles — Class IIa under Rule 6, not Rule 5. Endodontic access requires a surgically created opening, not a natural or permanent artificial body orifice.

• Saline nasal irrigation solutions — Class IIa under Rule 21, not Class I under Rule 5. These are substance-based devices applied in the nasal cavity to achieve their intended purpose locally.

Key Updates in MDCG 2021-24 Rev.1 

The revision to MDCG 2021-24 introduces targeted updates across several sections. classification rules and definitions. While the document’s overall structure is preserved, some of the changes are more significant than they first appear.

‘Surgical’ replaced with ‘clinical’ in the implantable device definition (Section 3.1.4) is the most consequential definitional change in the revision. The implantable device definition now refers to placement by ‘clinical intervention’ rather than ‘surgical intervention’, broadening the scope to encompass non-surgical placement procedures and aligning the guidance with MDR Article 2(5). Manufacturers who have relied on the ‘surgical’ framing to argue that a non-surgical placement procedure falls outside the implantable device definition will find that position harder to sustain. 

‘Device’ is replaced with ‘product’ in Section 3.2 to reflect the broader MDR scope, which includes Annex XVI products without a medical purpose. The classification rules apply to these products as well as to medical devices.  

Three new practical notes added to the classification rules are worth calling out specifically: 

• Rule 8 — Note 1 (Article 52(4) and Class IIb implantables) — Article 52(4) requires full technical documentation assessment for every Class IIb implantable device, with an exemption list that includes sutures, staples, screws, plates, wires, pins, clips, and connectors. Note 1 clarifies that inclusion on this exemption list does not mean those products are automatically classified as Class IIb. Each must be classified on its own merits according to its intended purpose and the applicable classification rules. 
• Rule 8 — Note 7 (Spinal column contact) — contact with the spinal column is now explicitly defined as intended contact with any bony structure forming the column — cervical, thoracic, lumbar, sacral, and coccyx — including the spinous and transverse processes. Hooks that fix rods on the spinal column are explicitly placed in the same category as screws, wedges, plates, and instruments, meaning they benefit from the Class IIb (not Class III) exemption in the last indent of Rule 8. 
• Rule 22 — Note 2 (Standalone defibrillator pads/electrodes) — defibrillator pads or electrodes placed on the market as standalone products and not as an integral part of an AED system, are not automatically Class III under Rule 22. They should instead be assessed under Rule 9 or Rule 1 based on their own characteristics and intended purpose. 

Additional updates include revised tables for Rules 2, 8, 10, 12, 16, and 22, a restructured Rule 9 section, and an expanded practical issues discussion for Rule 9 addressing the ‘potentially hazardous’ threshold for energy-administering active therapeutic devices. 

What This Means for Manufacturers 

Device classification is a living element of technical documentation, not just a one-time exercise. These guidance updates are a prompt to review whether existing classification rationale and borderline assessments remain defensible.

• Substance-based devices — competent authorities are applying the pharmacological/immunological/metabolic boundary strictly. Labelling alone is not sufficient. Borderline justifications must be evidence-based and explicitly documented in the technical file.
• Combination devices and devices with ancillary medicinal substances — Rule 14 Class III classification applies broadly. Review your Rule 14 analysis against MDCG 2022-5 if your device incorporates a substance with recognised biological activity in or on the human body.
• Implantable and long-term invasive devices — the shift from ‘surgical’ to ‘clinical’ intervention in the implantable device definition may affect products placed via non-surgical procedures. Confirm your classification rationale aligns with the updated language.
• Spinal implants and spinal column-adjacent devices — Note 7 to Rule 8 resolves previously ambiguous classification questions on spinal column contact and component exemptions. Review your classification if this applies to your product.
• Defibrillator accessories — standalone pads or electrodes should be assessed under Rule 9 or Rule 1, not Rule 22. Review your classification if you have assumed AED system integration.
• Any device referencing MDCG 2021-24 in the technical file — confirm that updated sections do not affect your classification conclusion and document the review.

How MedEnvoy Can Support 

MedEnvoy can assist manufacturers interpret relevant classification or borderline status changes, and how they may affect registered products across your service markets by providing support to ensure records remain accurate and up to date.

Our regulatory team can help assess whether these updates apply to your product portfolio, evaluate your existing classification justification or borderline analysis, and identify gaps in your technical documentation file. If you would like to discuss how these guidance updates apply to your products, you can connect with our regulatory experts by clicking here. Learn more about MedEnvoy’s EU Authorized Representative and importer services.