Regulatory background
Info.
On September 12, 2025, the Medical Device Coordination Group (MDCG) issued Version 4 of the Manual on Borderline and Classification for Medical Devices ("Manual V4"). This document consolidates the consensus positions reached by the Borderline and Classification Working Group (BCWG) under the Helsinki Procedure to support Member States and companies in determining product qualification and classification within the frameworks of the MDR (2017/745) and IVDR (2017/746). Although the manual is not legally binding, it is widely regarded in practice as an authoritative reference.
In the EU market compliance pathway, qualification must be determined before classification, and this is the starting point for all subsequent processes. Incorrect qualification or classification can create risks for technical documentation, Notified Body review, time to market, and overall compliance costs. For borderline products that may fall under different regulatory frameworks—such as medical devices, in vitro diagnostics, medicinal products, cosmetics, biocidal products, foods, or general consumer products—Manual V4 provides a clearer and more harmonized basis for assessment.
Key updates
New.
Multiple new borderline product and classification determinations have been added, including cases involving root canal irrigants, dual-action analgesic creams, wellness apps, and implantable devices, to promote consistency across Member States.
The manual more clearly distinguishes among the regulatory frameworks for medical devices, IVDs, medicinal products, biocidal products, cosmetics, PPE, and general consumer products.
The classification logic places greater emphasis on three elements:
• Intended purpose
• Mode of action
• and risk class
Representative cases
Case.
Analysis of typical cases with ambiguous borderline or classification definitions:
Device category | Is it a medical device? | Key rationale / assessment points |
RBC additive solutions with adenine | Yes (medical device), Class III (Rule 14) | Adenine can participate in RBC metabolism and has a pharmacological effect. As an ancillary medicinal substance incorporated into the device, it is classified as Class III under MDR Annex VIII, Rule 14. It is used to extend RBC storage time, and its effect complements the device's principal intended action. |
Dual-action pain relief cream with menthol and capsaicin | No (not a medical device) | Its principal effect is achieved through a pharmacological mechanism acting on receptors to relieve pain; this constitutes pharmacological action and therefore does not fall within the definition of a medical device. |
Vaginal lactose tablets | No (not a medical device) | Its principal effect is achieved through metabolic action, as the lactose is metabolized by endogenous vaginal lactobacilli; therefore, it does not meet the definition of a medical device. |
Tooth stain removal products using micro-abrasion (whitening) | No (not a medical device) | These products only improve appearance and do not treat or alleviate disease. If sufficient scientific evidence for a medical purpose cannot be provided, they should not be qualified as medical devices. |
Medical examination table covers) | Yes (medical device) | They are intended to prevent the transmission of infection and therefore meet the definition of a medical device under Article 2(1) of the MDR. *Note: the manual does not explicitly specify their risk classification; in general, Rule 1 may be considered as a reference, but confirmation is still required based on the specific product characteristics. |
Mobile sterile air system) | No (not a medical device) | Its function is to create an environment suitable for medical procedures; it does not itself have a specific medical purpose and does not directly act in or on the human body. |
Classification clarifications and harmonization
Clear.
• Dermal fillers: regarded as implantable devices; Rule 7 or Rule 8 applies depending on duration of use. Key assessment points: they are injected and implanted, meeting the definition of an implantable device; if wholly or mainly absorbed, Rule 7/8 applies with classification determined according to duration of use.
• n-butyl-2-cyanoacrylate (nBCA) venous closure adhesive: Class III. Key assessment points: regardless of absorption time, it is treated as Class III under the absorbable / biological effect principle in the third paragraph of Rule 8 of MDR Annex VIII, resolving previous inconsistencies.
• Argon coagulation units: Class IIb (Rule 9). Key assessment points: these are active therapeutic devices that deliver energy to human tissue in a potentially hazardous manner (electrical energy / plasma flow).
• Root canal irrigants containing sodium hypochlorite (NaOCl)/chlorhexidine gluconate (CHX): Class III (Rule 14, unless the absence of an antimicrobial/bactericidal effect is demonstrated). Key classification point: NaOCl/CHX are substances with pharmacological/antimicrobial effects; if sufficient scientific evidence does not exclude their antimicrobial/bactericidal action in vivo or on constituents of the human body, they are classified as Class III under Rule 14.
• Ethylene oxide (EtO) gas cartridges: at least Class IIa (Rule 16); if specifically intended for terminal disinfection of invasive devices, then Class IIb. Key classification point: as a critical component of the sterilization cycle, this is a product "specifically intended for disinfecting/sterilizing medical devices."
• Medical calculators (software): at least Class IIa (Rule 11), and potentially higher depending on the degree of impact on clinical decision-making. Key classification point: they provide information needed for diagnosis or treatment decisions, going beyond simple information processing and affecting individual patients.
• Custom-made cranial implants: Class III (Rule 8). Key classification point: direct contact with the central nervous system (meninges/dura mater) is sufficient for Class III classification, without any need to demonstrate an effect on tissue.
• FeNO exhaled nitric oxide measurement devices: IVD (in vitro diagnostic device). Key classification point: exhaled breath is no longer considered a constituent of the human body and is treated as a gaseous specimen derived from the human body; the device analyzes that specimen and therefore falls within the IVDR definition of an IVD.
Practical implications for manufacturers
Impact.
A. Reiterating: if the product’s primary mode of action is pharmacological, immunological, or metabolic, it cannot be qualified as a medical device. The manufacturer must demonstrate with sufficient, verifiable scientific evidence that the principal intended action is mechanical/physical, rather than relying solely on claims about intended purpose.
B. Correct qualification and classification determine the entire compliance strategy (technical documentation, clinical evaluation/performance evaluation, QMS, post-market oversight, economic operator obligations, etc.). Incorrect determination can lead to delayed technical review, rejection, or even market withdrawal.
Recommended compliance actions
Proposal.
A. Review the product portfolio and identify products affected by the new examples introduced in Manual V4;
B. Update the qualification and classification rationale in the technical documentation, and supplement the scientific justification and supporting test/literature evidence;
C. For borderline products that remain uncertain, engage early with the Notified Body or competent authority;
D. Establish an improvement plan before formal review and implement gap remediation to reduce compliance risk.
Reference:
[1].Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746, Version 4 – September 2025.
[2].MDR (EU) 2017/745: Article 1, Article 2 (definitions), Article 4 (regulations for certain product groups), Article 51 and Annex VIII (classification rules).
[3].IVDR (EU) 2017/746: Article 1, Article 2 (definitions), Article 3 (regulations for certain product groups), Article 47 and Annex VIII.
[4].MDCG 2022-5: Guidance on the borderline between medical devices and medicinal products; MDCG 2019-11: Qualification and classification of software; MDCG 2021-24: Guidance on classification of medical devices.