Borderline Manual v5: What Are the New Qualification and Classification Scenarios Under the MDR and IVDR?

Medical devices regulation

20 April 2026

Determining whether or not a product is a medical device sometimes seems obvious.

Until it isn’t.

A product may fall on the borderline between a drug, a cosmetic, a biocide, laboratory equipment, or a consumer product. In other situations, its classification as a medical device is undisputed, but the applicable classification rule remains uncertain.

These decisions are far from purely academic. They determine the applicable regulatory framework, the level of evidence required, the conformity assessment procedure, and, in some cases, the very feasibility of the project.

Version 5 of the Manual on Borderline Cases and Classification under Regulations (EU) 2017/745 and 2017/746, published on April 22, 2026, supplements the European manual with new cases concerning, in particular, combination products, substance-based devices, dentistry, and several MDR classification rules.

However, its value lies not only in the conclusions reached regarding a few specific products.

Above all, this new version demonstrates how European authorities structure their reasoning: they examine the product’s actual intended use, its primary mode of action, the available scientific data, and its specific conditions of use. A mere claim by the manufacturer is not sufficient to negate a known pharmacological property. Similarly, similarity to an already classified product never precludes a detailed analysis of how the product in question functions.

For manufacturers, therefore, the right question is not simply:

“Is there a case in the manual that resembles ours?”

It becomes:

“Are we able to document our qualification and classification with the same level of rigor as the authorities?”

What is the Borderline Manual?

The Borderline Manual compiles the common positions adopted by the competent authorities of the Member States within the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group.

Cases are reviewed under the Helsinki procedure, which allows authorities to discuss situations giving rise to differing interpretations and, once agreement is reached, to incorporate the common position into the manual.

The document covers two distinct regulatory issues.

Regulatory qualification

The first involves determining whether a product falls under:

the MDR;
the IVDR;
pharmaceutical regulations;
or another European regulatory framework.

This is the typical question regarding so-called “borderline” products.

Classification

Once a product has been classified as a medical device or an in vitro diagnostic medical device, the next step is to identify the applicable classification rule under Annex VIII of the MDR or the IVDR.

This distinction is essential.

A disagreement over qualification may result in a complete change of legal framework. A disagreement over classification keeps the product within the same regulation but may alter the CE marking procedure, the role of the notified body, and the level of evidence required.

Is the Borderline Manual v5 legally binding?

No.

The manual expressly states that the positions it contains are not legally binding. Only the Court of Justice of the European Union can provide an authoritative interpretation of EU law. National authorities and competent courts retain the responsibility to rule on a case-by-case basis.

The manual also specifies that it is not an official document of the European Commission and cannot be considered to express its official position.

This does not, however, diminish its practical importance.

The handbook helps to understand:

which criteria the authorities consider decisive;
what evidence they expect;
what lines of reasoning they consider insufficient;
and in which situations a classification or qualification is likely to be challenged.

A published case therefore serves as a particularly useful point of comparison, but it is not a decision that can automatically be applied.

To use it correctly, the manufacturer must demonstrate that its product is comparable to the case studied in terms of intended use, composition, mode of action, and conditions of use. A commercial or technological resemblance is not sufficient.

Why is Version 5 of the Borderline Manual important?

Version 5 adds several cases that share a common lesson: authorities are placing increasing emphasis on the scientific analysis of how the product actually works.

Three trends stand out in particular.

Classification does not depend solely on the wording used in the package insert or marketing materials.
The primary mode of action must be scientifically demonstrated, not merely stated.
Classification depends on the actual conditions of use of the product, sometimes more so than on its appearance or technology.

These principles already existed in the MDR and associated guidelines. Version 5, however, gives them very concrete application.

Case Study	Regulatory issue	Key Takeaway
Rectal tube containing a drug	Is it a single-product device or merely packaging?	The administration portion may be subject to the requirements applicable to the device portion of a complete product
Root canal irrigation solutions	Mechanical or pharmacological action?	The scientifically established properties of the substances must be taken into account
Additive solution containing adenine	Metabolic or ancillary pharmacological action?	The substance’s secondary action may result in a Class III classification under Rule 14
Endodontic irrigation needle	Natural body orifice or surgically created access?	The actual route of administration determines the classification rule
Nasal saline solution	Rule 5 or Rule 21?	A device consisting of substances that act locally in the nasal cavity falls under Rule 21
Syringe containing glass beads	Simple centrifugation or modification of blood?	The device’s actual function leads to the application of Rule 3

What else does Version 5 specify regarding the IVDR?

While the majority of newly published cases concern the MDR, Version 5 also provides an important clarification regarding the scope of the IVDR.

In particular, the manual examines a system for measuring exhaled nitric oxide (FeNO) designed to provide information on a physiological or pathological condition based on the analysis of exhaled air.

The regulatory issue does not concern the technology used but rather the nature of the sample being analyzed.

The Borderline Manual considers exhaled air to be a specimen derived from the human body. The system therefore meets the definition of an in vitro diagnostic medical device under the IVDR.

This case serves as a reminder that the distinction between the MDR and the IVDR does not depend solely on contact with the patient or the technology employed. It also depends on the object being analyzed, the origin of the sample, and the intended diagnostic purpose.

What does the Borderline Manual v5 specify regarding combined drug-device products?

One of the new cases involves a single-dose tube equipped with a long cannula, intended for the rectal administration of a laxative.

The administration component meets the definition of a medical device: it is inserted into a body orifice to administer a drug.

However, when it is placed on the market together with the drug as a single, integrated product—intended exclusively for this combination and not reusable—the entire assembly falls under drug regulations in accordance with Article 1 (9) of the MDR.

The device component remains subject to the relevant general safety and performance requirements of Annex I of the MDR. Evidence of this compliance must be included in the medicinal product’s regulatory dossier. Depending on the situation, this demonstration is based on the CE marking of the device part or on an opinion from a notified body in accordance with Article 117.

This distinction is important.

Saying that a product “falls under Article 117” does not mean that the entire product is regulated as a medical device. Article 117 sets forth the process for demonstrating the medical device component’s compliance within the drug’s regulatory dossier.

For a manufacturer, this conclusion must be incorporated very early in the development process. The conformity of the device component cannot be treated as a mere packaging issue added at the end of the project.

Why are the manufacturer’s claims insufficient to rule out a pharmacological effect?

The case of root canal irrigation solutions is likely one of the most instructive examples in Version 5.

The products under review contain either a 3% sodium hypochlorite solution or a 2% chlorhexidine solution. The manufacturer presents them as acting primarily through irrigation and the mechanical removal of debris, without claiming any disinfectant action.

The manual does not stop at this lack of a claim.

Sodium hypochlorite and chlorhexidine possess documented antimicrobial properties. Determining whether an effect is pharmacological or incidental therefore does not depend solely on the manufacturer’s stated intent. It must be established based on the available scientific data.

The reasoning involves two steps.

Does the product meet the definition of a medical device?

The manufacturer must first demonstrate that the primary intended action is based on rinsing, irrigation, and the mechanical removal of debris and necrotic tissue.

Once this has been demonstrated, the product may meet the definition of a medical device.

Does the substance have an ancillary action?

Even if the primary action is mechanical, the presence of a substance with an ancillary antimicrobial or antiseptic action must then be taken into account.

In the absence of robust scientific evidence demonstrating that sodium hypochlorite or chlorhexidine does not exert this effect under the relevant conditions of use, the solutions must be classified as Class III under Rule 14.

The lesson is clear: a manufacturer cannot determine the regulatory classification of its product solely by controlling its claims.

When the scientific literature describes a relevant pharmacological action, it is included in the analysis, regardless of whether or not it is highlighted in marketing materials.

What changes does Version 5 bring for devices containing adenine?

The manual also examines additive solutions containing adenine used in systems for the processing and preservation of red blood cell concentrates.

Adenine helps maintain ATP production and preserve red blood cells. The manual considers that its mechanism of action may be metabolic, pharmacological, or a combination of both mechanisms.

When this substance is incorporated into the device and exerts an ancillary effect, Rule 14 results in a Class III classification.

This case demonstrates that a substance can significantly alter the classification of a system, even when it is not the most visually prominent component.

For the manufacturer, the analysis must therefore not stop at the system’s overall function. It must delve down to the level of the components, their mode of action, and their exact contribution to the product’s intended use.

What new classification cases does the Borderline Manual v5 add?

Needles intended for endodontic irrigation: why does Rule 6 apply?

Certain endodontic irrigation needles had been classified as Class I under Rule 5, on the grounds that they were inserted into a cavity and no incision of soft tissue was made.

The manual takes a different approach.

Access to the root canal requires the prior creation of an opening in the tooth. This access is neither natural nor permanent. The use of the needle therefore depends on a clinical procedure that artificially creates a pathway of entry.

The device must be considered surgically invasive and falls under Rule 6. Given its temporary use, it is classified as Class IIa.

This case illustrates a principle that extends beyond dentistry: the classification of the access route may be more decisive than the physical form of the device.

Saline nasal irrigation solutions: why does Rule 21 prevail?

Certain nasal saline solutions had been classified as Class I under Rule 5, which applies to devices that are invasive through a body orifice.

Version 5 adopts Rule 21.

The solution consists of a combination of substances introduced into the nasal cavity, where it acts locally by dissolving mucus. It therefore falls under the category of devices composed of substances applied to a body cavity and acting locally, leading to a Class IIa classification.

The lesson here is important: when a specific rule precisely describes how a product works, it takes precedence over a more general interpretation based solely on the route of administration.

Syringe containing glass beads: simple centrifugation or blood modification?

The manual also discusses a syringe containing glass beads, used to collect blood, incubate it, centrifuge it, and obtain packaged autologous serum intended for readministration to the same patient.

The glass beads increase the contact surface area and contribute to the activation of coagulation. The manual considers that the biological and chemical composition of the blood is altered by the cumulative effect of incubation and centrifugation.

This is therefore not a simple centrifugation process falling under the exception provided for in Rule 3. The device is classified as Class IIb.

This case demonstrates once again that the name of the process alone is not sufficient. “Centrifugation” may be a simple procedure under regulatory terms or part of a broader blood processing procedure, depending on the device’s other functions.

How can we use the Borderline Manual without turning it into a catalog of answers?

It is very tempting to search the manual for an identical or similar product and then directly adopt its conclusion.

This approach is flawed.

A case in the Borderline Manual is relevant only if the manufacturer demonstrates that the determining factors are comparable:

claimed intended use;
composition;
primary mode of action;
secondary effects;
target population;
conditions of use;
route of administration;
duration and nature of contact;
function performed on the body, tissues, or samples.

Two seemingly similar products may lead to different conclusions if even one of these elements changes.

The manual should therefore be used as a framework for interpretation, not as a catalog of ready-made classifications.

How should the regulatory classification of a borderline product be documented?

For a product that may fall under multiple regulatory frameworks, a robust justification should be developed from the earliest stages of development.

This may include, in particular:

A precise description of the claimed intended use, users, target population, and conditions of use.
An analysis of the primary mode of action, distinguishing between physical, pharmacological, immunological, and metabolic mechanisms.
Identification of secondary actions, particularly when the product contains substances known for their biological effects.
A targeted literature review focusing on the substance’s properties, mechanisms of action, and the state of the art.
An analysis of competing regulatory frameworks, rather than a discussion limited solely to the MDR.
A reasoned comparison with the cases in the Borderline Manual, explaining both the similarities and the differences.
A formal conclusion, accompanied by assumptions, uncertainties, and points that may require discussion with a competent authority.

This analysis must be consistent with the clinical or performance evaluation, risk management, technical documentation, and marketing claims.

A robust regulatory qualification is not merely about reaching a conclusion. It involves demonstrating why other regulatory frameworks or classification rules were not selected.

A regulatory qualification that exists only in an initial project PowerPoint presentation generally does not stand the test of time very well.

When should a regulatory analysis be expanded upon?

Situation Encountered	Recommended Approach
The regulatory framework seems obvious	Nevertheless, formalize the rationale in the regulatory strategy and technical documentation.
The primary mechanism of action remains under debate	Generate additional scientific data before finalizing the regulatory strategy.
Several regulatory frameworks remain plausible	Conduct a well-reasoned comparative analysis and consider early engagement with the competent authority if uncertainty persists.
The classification rule is uncertain	Justify the chosen rule, but also explain why the other applicable rules were ruled out.
A case from the Borderline Manual appears comparable	Use the case as an analytical framework, documenting the similarities, differences, and their impact on the conclusion.

Case Study #1: A drug delivery device

A company is developing a single-dose tube equipped with a cannula, pre-filled with a drug intended for rectal administration.

The team initially considers the tube to be merely primary packaging.

However, the analysis shows that the cannula allows for the insertion and administration of the drug into a body orifice. This component therefore meets the definition of a medical device.

Since the tube and the drug are placed on the market as a single, integral, non-reusable product intended exclusively for this combination, the entire assembly falls under drug regulations. The device component must nevertheless meet the relevant requirements of Annex I of the MDR, and the corresponding demonstration must be incorporated into the Article 117 strategy.

The issue, therefore, is not whether the product is “a drug or a device.”

Rather, it is to understand how the two regulatory frameworks interact within the same product.

Case Study No. 2: An irrigation solution whose action is described as mechanical

A manufacturer is developing a solution containing a substance known for its antimicrobial properties.

The package insert highlights only a mechanical rinsing action for the removal of debris. The team considers that the absence of a disinfectant claim is sufficient to rule out a pharmacological action.

This conclusion is tenuous.

The manufacturer must demonstrate, based on robust scientific data representative of actual conditions of use, that the primary action is mechanical. It must also analyze the possible existence of an ancillary antimicrobial action.

Marketing messaging never replaces an analysis of the mechanism of action; it must be the result of that analysis. In practice, the regulatory analysis should be finalized before marketing claims are drafted, rather than adapted retroactively to justify a positioning that has already been decided upon.

Mini FAQ

Is the Borderline Manual v5 legally binding?

No. It reflects the agreements reached among the competent authorities participating in the BCWG. Decisions continue to be made on a case-by-case basis by the competent authorities and courts.

Does a case in the manual automatically apply to all similar products?

No. The manufacturer must demonstrate the comparability of the intended use, composition, mechanism of action, and conditions of use.

Can the manufacturer exclude a pharmacological action by removing the corresponding claim?

No. The scientifically established properties of the product or its substances must be taken into account regardless of the marketing terminology used.

When should a competent authority be consulted?

When a documented analysis no longer allows for the reasonable exclusion of multiple regulatory frameworks or classification rules, early engagement with the competent authority can safeguard the development strategy before major technical decisions become difficult to reverse.

When should a product’s borderline status be analyzed?

As early as possible. An incorrect classification can affect the development strategy, the evidence to be provided, the compliance process, and the timeline for market access.

Related Resources

Establishing a Regulatory Strategy Begins Well Before CE Marking

Version 5 of the Borderline Manual perfectly illustrates the evolution of the European regulatory framework: qualification and classification decisions are increasingly based on in-depth scientific analysis rather than solely on the manufacturer’s claims. For companies developing innovative products, incorporating these interpretations from the earliest stages of development helps secure the regulatory strategy and avoid challenges later on. With this in mind, CSDmed supports manufacturers in building robust dossiers that align with the expectations of regulatory authorities and notified bodies.

Let’s discuss this together.

Source