The article highlights the key points to be considered when determining the regulatory nature of products considered general medical devices.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework, has published a manual on borderline products. The document describes in detail the approach to be applied when determining the regulatory status of the products in cases when it is questionable. In particular, the guidance outlines the aspects to be taken into consideration when making such a determination and also provides recommendations associated thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications on the matter.
The scope of the manual covers, inter alia, the regulatory requirements for general medical devices set forth by the Regulation (EU) 2017/745 (MDR) which has recently replaced the respective Directive. The document also provides several examples demonstrating the way the approach described in the manual should be applied in specific cases. However, the examples and recommendations provided in the document are not exhaustive, and each time the final decision is to be made on a case-by-case basis.
Borderline Between Medical Devices and Medicinal Products
For instance, the document describes the way medical devices should be distinguished from medicines and medicinal products from a regulatory perspective. The examples provided by the MDCG include, inter alia, the following ones:
- A nasal spray with antibodies for COVID-19 is intended to inactivate the virus. First of all, it is important to determine the principal mode of action – the way the product achieves its intended purpose. In such a case, the principal intended action of the spray is achieved through antibodies binding to the virus – as a result, the virus is no longer able to reproduce and enter mucosal cells. It is further stated that according to the general definition of a medical device, the intended action of a product considered to be a medical device cannot be achieved by pharmacological, immunological, or metabolic means. Thus, based on this criterion, the product in question should be regulated as a medicinal product rather than as a medical device.
- Graphite crucible intended to be used together with the radionuclide Technetium-99m to make images of the patient’s airways (to prepare an aerosol). Such an aerosol should be inhaled, while a gamma camera will be used to get an image. According to the applicable legislation, any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for medicinal purposes, is a radiopharmaceutical. It is also stated that a kit stands for any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually before its administration. In this particular case, due to the intended purpose of the product in question and the way it is intended to operate, it does not meet the definition of a medical device, hence, would not be subject to regulation under the framework of the medical device.
Borderline Between Medical Devices and Biocides
The guidance further outlines the key points to distinguish medical devices and biocides, which are subject to regulation under Regulation (EU) 528/2012 addressing the matters related to biocidal products intended to be marketed and used in the EU. To describe the approach to be applied when making such a determination, the authority also provides several examples. For instance, the first example describes a concentrate for water-based treatment of textile materials intended to impart antimicrobial and antiviral properties. In such a case, since the said treatment does not apply to specific patients, but is intended to impact the characteristics of other products, it does not meet the definition of a medical device and should not be regulated as such.
Other Types of Products
The scope of the guidance also covers matters related to substances of human origin, cosmetic products, food, and personal protective equipment. The latter type of healthcare product addressed by Regulation (EU) 2016/425 is the one sometimes confused with medical devices, so the authority provides a detailed explanation and examples illustrating the approach to be applied. The first product described is a rescue bag intended for the transportation of patients in the course of rescue operations to ensure their support and protection. In particular, such a bag has elements intended to ensure mechanical protection of the patient during transportation, including when different transportation devices are used. The overall purpose of the rescue bag is to avoid the worsening of the patient’s state due to the impact of external factors the patient could be subject to during the salvage. The authority states that the intended purpose of the product corresponds to the medical purpose of alleviation of, or compensation for, an injury or disability, according to Art. 2(1) of the MDR, hence, it should be therefore qualified as a medical device; while the risk class should be MDR class I, according to rule 1.
Another example provided in the guidance describes the Plexiglas box for caregiver protection – the one intended to be used to reduce the risks associated with the infection to be transmitted in the course of procedures undertaken. In this respect, the authority explains that a product solely intended to protect a caregiver or health care professional by preventing exposure during a medical or surgical procedure, should not be qualified as a medical device. It is further explained that such a purpose could not be the purpose of a medical device, since the latter is to be intended to protect the patient.
In summary, the present MDCG manual describes the approach to be applied when determining the regulatory status of borderline products that could potentially be confused with medical devices. The document highlights the key points to be taken into consideration and also provides examples intended to assist medical device manufacturers and other parties involved in interpreting and following the principles described therein.
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