This article elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
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The Medical Device Coordination Group (MDCG), an organization composed of representatives of all Member States and focused on further improvement of the existing legal framework, has published a guidance document dedicated to the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could also be subject to changes, should such changes be reasonably necessary to reflect corresponding regulatory developments.
Overview of Substance-Based Medical Devices
According to the guidance, substance-based medical devices refer to devices primarily composed of substances that fulfill the criteria of a medical device without achieving their main intended action through pharmacological, metabolic, or immunological means. Although some components may have an ancillary pharmacological or immunological action, this should be secondary to the device’s primary function.
These devices may resemble medicinal products in formulation or application methods, such as being ingested or applied topically. Importantly, while the term “substance” lacks a specific definition under MDR, it broadly excludes certain entities, including viable biological material, animal or human tissues, cells, and organisms.
Classification Rules for Substance-Based Devices
Under the MDR, two classification rules specifically address the risks associated with substance-based medical devices: Rule 3 and Rule 21. Not all substance-based devices are covered by these two rules; when they are not, general MDR classification rules apply.
- Rule 3: Applies to devices consisting of substances used in vitro in direct contact with human tissues, cells, organs, or embryos before reintroduction into the body.
- Rule 21: Applies to devices intended to be introduced into the body via a body orifice or applied to the skin, where they may be absorbed or locally dispersed in the human body.
If a substance-based device includes an ancillary medicinal component, manufacturers may need to consult with a competent authority or the EMA, as outlined in Annex IX of the MDR. This procedure ensures that medicinal attributes are correctly evaluated.
Medical Devices for In Vitro Use with Human Cells or Tissues
Rule 3 covers substance-based devices intended for in vitro applications that involve direct contact with human cells, tissues, or embryos. These products are designed to treat or prepare body tissues and fluids outside the body before they are reintroduced.
Examples:
- Organ Transport Solutions: Solutions that support the transportation of organs for transplantation without pharmacological or immunological action.
- IVF Media: Culture media used in in vitro fertilization procedures.
These examples clearly demonstrate that the rule is focused on extracorporeal treatments, supporting tissue viability or preparation rather than modifying tissue function directly.
Substance-Based Devices Introduced into the Human Body or Applied to Skin
Rule 21 applies to devices composed of substances intended to enter the human body or be applied to the skin, where they are absorbed or act locally. These devices achieve their purpose without systemic pharmacological effects.
Examples:
- Na/Mg Alginate and Xyloglucan: Substances used for various therapeutic or preventive purposes within the body.
- Skin Treatment Formulations: Topical preparations for skin application without systemic effects.
- Saltwater Sprays: Used as nasal or throat sprays.
- Oral Cough Treatments: Intended to act locally within the oral cavity and pharynx.
- Simethicone and Active Coal: Substances for oral administration for digestive relief.
Additional examples include vaginal moisturizers, eye drops for hydration, and ear drops, all of which achieve localized effects without pharmacologically altering bodily functions.
Other Substance-Based Devices
For substance-based devices that do not specifically fall under Rules 3 or 21, general MDR classification rules apply. In such cases, manufacturers must follow standard MDR requirements and any medicinal component must be demonstrated to be ancillary to the device’s principal purpose.
For products intended to achieve systemic absorption or for substances that would be medicinal if used alone, a consultation with relevant authorities is required to ensure the device classification aligns with MDR requirements.
Conclusion
In summary, the document clarifies that substance-based medical devices represent a unique category within MDR, defined by their primary reliance on physical or mechanical rather than pharmacological action. Through specific classification rules and consultation procedures, the MDR ensures these devices are evaluated appropriately. The authority also stated that manufacturers must provide scientific evidence to demonstrate the intended action of the device and, where relevant, undergo additional consultation to validate the ancillary nature of any medicinal attributes, upholding the distinct regulatory pathway for these devices.
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