Version 4 of the EU Borderline & Classification Manual (September 2025) introduces new examples that sharpen the distinction between medical devices and other product categories. This update includes clarified classifications for products containing pharmacologically active substances, and aesthetic-only products.
In the ever-changing regulatory landscape of the EU MDR and IVDR, access to clear and reliable information is essential. Particularly for borderline products which may fall under different frameworks such as medical devices, pharmaceuticals, cosmetics, biocides or even food. On 12 September 2025, the Medical Device Coordination Group (MDCG) published the fourth version of the ‘Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746‘. This edition brings together the agreements made by representatives the Borderline and Classification Working Group (BCWG) related to Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This manual serves as a vital interpretive and supportive tool when preparing qualification and classification rationales, although it is not a legally binding document. The aspects concerning the borderline between medical devices and other types of products, also known as the qualification of a product, are generally governed by Article 4, Regulatory status of products of the MDR and the corresponding Article 3 of the IVDR. Borderline cases are those for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device, or not. Once a product is qualified as a medical device, a certain risk class will be assigned to it, namely I, IIa, IIb, and III. For a product qualified as an IVD, the risk classes are A, B, C and D.
Key updates include:
- The addition includes multiple concrete examples of qualification and classification, such as endodontic irrigation solutions, dual-action creams, health apps, implantable devices, etc., aimed at supporting a more harmonised interpretation of EU regulations for the benefit of patient safety and the internal market.
- Clearer distinctions between medical devices, IVDs, medicinal products, biocides, cosmetics, PPE, and consumer goods.
- A refined classification logic that places greater emphasis on intended purpose, mode of action, and risk level.
- Qualification of medical devices.
The following devices were added to Version 4 of the guidance:
| Product | Is it a medical device? | Key reasoning |
|---|---|---|
| Borderline between medical devices and medicinal products | ||
| Red blood cell additive solutions containing adenine | Yes, Class III | Adenine is a substance, increases adenosine monophosphate (AMP) in the blood and is used to increase the shelf life of the red blood cells. Its action can be metabolic or pharmacological, as defined in MDCG 2022-5. When used in additive solutions for RBC processing, adenine acts as an ancillary medicinal substance, and the device should therefore be classified as Class III under Rule 14. |
| Dual action cream with menthol and capsaicin | Not a device | The cream is intended to relieve muscle and joint pain. Menthol and capsaicin exert recognised pharmacological effects by acting on receptors. Since the principal effect is pharmacological, the product does not qualify as a medical device. |
| Lactose tablets for vaginal use | Not a device | The lactose tablet achieves its principal intended action by metabolic means in or on the human body, as the consumption of the lactose by the lactic acid bacteria is a metabolic process, and the indigenous lactic bacteria is considered as part of the human body and therefore does not qualify as a medical device. |
| Borderline between medical devices and cosmetic products | ||
| Microabrasion dental stain removers | Not a device Excluded as aesthetic-only products. | Products intended to remove dental stains and improve the appearance of teeth serve a purely aesthetic purpose, regardless of method or underlying cause. They do not treat conditions such as amelogenesis imperfecta or cleidocranial dysplasia and therefore do not meet the MDR definition of a medical device. |
| Borderline between medical devices and personal protective equipment | ||
| Medical examination table covers | Yes, Class I devices | Medical examination table covers are intended to cover patient tables in medical exam rooms to maintain hygiene and prevent the transmission of infectious agents. As they serve a specific medical purpose—disease prevention—they meet the MDR definition of a medical device (Article 2, point 1, EU 2017/745). |
| Other medical device borderlines | ||
| Mobile sterile air system | Not a device | The product’s purpose is to remove harmful pathogens and reduce infection risk, enabling a safe environment for medical procedures, but it does not have a specific medical purpose itself and is therefore not a medical device. |
Classification of medical devices
In addition to qualification issues, Version 4 includes important clarifications on device classification, ensuring greater consistency across Member States.
- Dermal fillers are confirmed as implantable devices, falling under Rules 7 and 8, depending on duration of use.
- n-butyl-2-cyanoacrylate (nBCA)-based adhesives for vein closure are always classified as Class III, regardless of absorption time, ending long-standing debates on risk class justification.
- Argon coagulation units classified as Class IIb (active therapeutic) devices under Rule 9 due to delivering potentially hazardous energy in a therapeutic context.
- Root canal irrigants with sodium hypochlorite (NaOCl) or chlorhexidine digluconate (CHX) classified as Class III according to Rule 14 unless proven otherwise.
- Ethylene oxide gas cartridges are classified as Class IIa (or IIb depending on use), since they are integral to sterilisation processes for medical devices.
- Medical calculators are reinforced as at least Class IIa under Rule 11 but may be higher depending on their impact on clinical decisions.
- Custom-made cranial implants are now clearly established as Class III due to direct contact with the central nervous system, irrespective of the interaction mechanism.
Finally, the fractional exhaled Nitric Oxide (FeNO) measuring device is explicitly qualified as an IVD, as exhaled breath is considered a specimen derived from the human body.
Why Does Borderline Matter to the Manufacturers?
For organisations developing products that may sit on the borderline between a medical device, IVD, medicinal product, or consumer product, this latest update is essential reading. While it provides valuable clarity, it also raises expectations for scientific justification and evidence, making early and accurate qualification decisions more critical than ever. This is important because:
- Determining whether a product is a medical device, an IVD, or falls outside the scope of these regulations is often the first and most critical regulatory decision. Incorrect qualification can result in significant consequences, including regulatory delays, compliance risks, or even market withdrawal.
- Deciding on product classifications is crucial as it impacts the entire regulatory process. Misclassifying products can lead to delays, rejections of submissions, or loss of time and resources, or forced market withdrawal.
- Version 4 reinforces a recurring principle: if a product’s principal mode of action is pharmacological, immunological, or metabolic, it cannot be a medical device. Manufacturers must therefore provide robust scientific evidence to demonstrate mechanical or physical claims, rather than relying solely on intended use statements.
Next Steps for Manufacturers
Review your portfolios to identify products potentially impacted by the new examples in version 4.
- Update borderline and classification justifications with robust evidence in technical documentation.
- Engage early with notified bodies or competent authorities where uncertainty remains.
- Plan proactively to address the gaps before assessments or audits to reduce compliance risks.
Unsure about your product’s status under EU MDR or IVDR? Contact us today for a no-obligation, confidential discussion on how we can support your path forward.
