The MDCG has released new guidance on borderline cases between medical devices and medicinal products under the Medical Devices Regulation 2017/745. This guidance addresses several concepts such as the definition of a medicinal product, medical diagnosis, pharmacological, immunological and metabolic means, among others. Under the concept of principal intended action, it is worth mentioning that:
Although the manufacturer’s claims are essential, 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. References to or making available by the manufacturer of information or data on the safety or performance of the product is not relevant for the determination of its regulatory status.
The guidance also provides a helpful flowchart for determining if a product fulfils the definition of a medical device as per the MDR.
The division is then made between herbal products, substance-based medical devices, and medical devices and medicinal product combinations. Among products considered herbal medicinal products are the following:
- Cough syrup;
- Wound healing ointment;
- Vaginal ovules A and B;
The guidance states the composition of each product and the claims made.
Furthermore, on substance-based medical devices, it is relevant to mention that the ancillary nature of the pharmacological, immunological, or metabolic action of the substances is a vital element for the qualification of the product as a medical device. In this sense, the guidance addresses the following medical devices:
- Medical devices consisting of a substance or mixture of substances used in vitro in direct contact with human cells, tissues, organs, or human embryos before their implantation or administration
- Example: Solutions for the transport of organs for transplantation (that do not achieve their principal intended action via pharmacological, immunological or metabolic means);
- Medical devices composed of substances or of combinations of substances that are
- intended to be introduced into the human body or applied to the skin
- Examples: Ear drops; Eye drops for hydration; Nose or throat sprays;
Finally, regarding medical devices and medicinal product combinations, the MDCG guidance includes a decision tree for determining the regulatory status of combination products, also giving examples of devices under this category that are regulated as medicinal products:
- Syringes prefilled with a medicinal product;
- Aerosols containing a medicinal product;
- Temporary root canal fillers incorporating medicinal products, whose purpose is to deliver the medicinal product;
Examples of medical devices for administration of medicinal products:
- Drug delivery pumps;
- Implantable infusion pumps;
- Syringes, jet injectors;
Medical devices incorporating, as an integral part, an ancillary medicinal product:
- Catheters coated with heparin or an antibiotic agent;
- Bone cements containing antibiotic;
- Soft tissue fillers incorporating local anaesthetics;
and medical devices incorporating, as an integral part, a human blood or human plasma derivative:
- Haemostatic agent / matrix containing human thrombin;
- Culture media used in IVF containing human albumin solution;
You can read the full guidance in our Library of Documents – MDR – MDCG.
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