MDCG issues guidance to help define ‘borderline’ products

Regulatory NewsRegulatory News | 28 April 2022 |  By 

Developers struggling to decide whether their products are drugs or devices now have clearer definitions thanks to new guidance issued by the European Commission’s Medical Device Coordination Group (MDCG).
In general, determining whether a product is a device covered by the Medical Devices Regulation 2017/745 or a medicine covered by Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) is straightforward.
For other products – like medical devices incorporating a substance that would otherwise be considered to be a drug – it is not always clear whether they fall under the MDR or the MPD. 
The new MDCG guidance document seeks to clarify how developers can identify the correct regulatory framework for these so-called “borderline” cases by providing clear descriptions of various types of product and explaining how the differ.
It also provides a flowchart that developers can use to determine if a product meets the definition of a medical device under the MDR.
According to the document, the flowchart is designed to help developers determine “whether a product fulfills the definition of a medical device per the MDR in order to ensure a consistent approach in the decisions concerning the borderline between medical devices and medicinal products.”
Concepts and claims
In addition to the flowchart, the guidance also provides several conceptual models that can be used to help determine whether the product is a drug or a device.
For example, developers claiming their products are devices are called on to define the product’s “specific medical purpose” based on categories set out in the indents of Article 2(1) of MDR. Similarly, device claimants are also required to describe the “principal intended action” of their product.
Likewise, those developing “drugs” are asked to describe the product’s “principal mode of action.” According to the guidance the “principal mode of action” is the means by which it achieves its action according to the MDCG.
However, while manufacturer’s status claims and the supporting data will be taken into consideration, they will not be definitive, according to the guidance.
“Although the manufacturer's claims are important, it is not possible to place the product in one or other regulatory category in contradiction with current scientific data. Manufacturers will be required to justify scientifically in the technical file their rationale for the qualification of their product. A product cannot be qualified as a medical device within the meaning of Article 2(1) of the MDR if it cannot be determined that the product’s principal intended action is achieved by other than pharmacological, immunological or metabolic means,” the guidance states. It adds that “references to or making available by the manufacturer of information or data on safety or performance of the product is not relevant for the determination of its regulatory status.”
Substance based devices
The guidance document also provides a definition for substance-based medical devices, which is a device composed of substances that does not achieve its principal intended action by pharmacological, metabolic or immunological means.
The challenge is that the term ‘substance’ is not defined in the MDR. The term is defined in the MPD, however, as the guidance points out, “this definition includes substances that are not permitted in medical devices.
“Therefore a substance-based medical device where the substance falls under the definition in the MPD must also satisfy all other aspects of the definition of a medical device as specified in Article 1 and 2 of the MDR.”
The guidance also covers medical device and medicinal product combinations. Much of this sections focuses on where the substance contained in the device is “integral.”
“When deciding on the regulatory status of a product combination, the first step is establishing whether the product under consideration is an integral product … As a second step, it should be determined if the action of the medicinal product incorporated in the device is principal or ancillary to that of the device part of the integral product.
The guidance goes on to explain that if the principal intended action of the integral product is achieved by the substance, the entire product is regulated as a medicinal product under Directive 2001/83/EC or Regulation (EC) No 726/2004.
However, if the principal intended action is achieved by the medical device “the entire product is regulated under the MDR as a medical device incorporating a medicinal product that has an action ancillary to that of the device.”
It also states that “Devices for administration of medicinal products where the medicinal product is supplied separately (Article 1(9) first paragraph) are not integral products.”


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