MHRA Guidance on Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial cases. The document is intended to assist all parties involved in making the correct determination of the borderline products.
Medical Product Determination
Sometimes it (could) can be quite difficult to perform the correct determination of certain products (having) that have (particular features similar) similar features to medicines and medical devices. Such products fall within the category of borderline products. To assist in the determination, the MHRA provides a detailed description of the approach (to be) that should be used when dealing with borderline products. Actually, “borderline product” is a category the product should be assigned to if its correct determination is not obvious due to its design, features, and functions. This is a temporary category to be used prior to the final determination.
According to the guidance, the list of (products) items usually determined as borderline products includes:
- Food products and supplements,
- Medical devices,
- Laboratory equipment,
- Herbal products,
The authority also emphasizes another borderline existing between medical products and medical devices. In such cases, the final determination should be based on the claims stated by the manufacturer, and also on the primary mode of action. Using these criteria, the authority would be able to determine the particular regulatory framework to be applied for such devices.
Borderline Medicines Determination
According to the guidance, the product subject to review should be identified as a medicinal product in case if it meets the following criteria:
- It constitutes a single substance or their combination and is claimed to be used for preventing or treating disease
- It could be used for the purpose of impacting the physiological function of a human in the means of restoring, modifying or correcting it through the pharmacological, immunological or metabolic action
The document provides that, in accordance with the general rule, food supplements should be subject to the regulation and supervision as food. (This) These food safety and labeling requirements should be applied to such products.
For the purpose of determining whether the product subject to review is a medicinal product or not, the MHRA utilizes such criteria as claims made by the manufacturer of the product and the substances the product is composed of. The same criteria would be used in (case of) reviewing products containing herbal ingredients.
In accordance with the guidance, the MHRA would perform its own determination upon the appropriate request submitted by the manufacturer failing to perform the correct determination itself or in the case of receiving complaints regarding the products marketed as medicinal products but having no appropriate features.
When performing the final determination, the MHRA would make its decision based on:
- The claims made by the manufacturer regarding the impact of the product,
- The features and properties of its components (including pharmacological, metabolic or immunological ones),
- The intended purpose of the product as defined by the manufacturer,
- The presence of other products on the market and the regulatory status of such products,
- The information accompanying the product (including the information contained in its labels, packaging as well as promotional and advertising materials).
Borderline Medical Devices Determination
Under the general rule, all medical devices could be divided into three main categories: medical devices covered by the general regulation, in vitro diagnostic medical devices, and active implantable medical devices. In cases of any doubts in determination, the authority would be able to assist in assigning the device to the correct category. The MHRA also emphasizes that in certain cases the product determined as a medical device outside the EU could have another determination under the EU regulatory framework.
According to the document, the final determination should depend on the intended purpose indicated by the manufacturer and its primary mode of action. It is important to mention that in the case of medical devices, the primary mode of action should utilize physical principles – this is one of the most important criteria used to distinguish medicines and medical t5rdevices.
Borderlines Between Medicinal Products and Medical Devices
To assist all parties involved in distinguishing medicinal products and medical devices the MHRA refers to the appropriate guidance issued by the authority earlier in 2016.
According to the document, medicinal products could be subject to regulation either as medical devices or as medicines. At the same time, after the implementation of the MDR, some of the products previously regulated as medicines fall within the scope of medical device regulation. In particular, the list of such products includes, among others, the following ones:
- Absorbable surgical materials
- Some of the dental products
- Contact lens care products
- Wound dressings and some other products.
At the same time, the proper determination of some medicinal products, such as non-medicated dermatological products or artificial tears, should be defined on a case-by-case basis. However, some of the aspects related to the determination of medicinal products still remain unclear.
As in the case with other borderline products, the final determination should be based on the following criteria:
- The intended purpose of the product subject to review, including the way it is marketed
- The particular method by which the primary action is achieved
As it was mentioned before, to be determined as a medical device, a product should be based on the physical methods. (while) For medicines the principle of action is usually based on pharmacological, immunological or metabolic means.
There is a specific category of medical devices containing medicinal substances acting in a supporting manner. Such devices could be defined as combination products, including medical device – medicine and medicine – medical device combination products. According to the guidance, in such cases, the final determination should be based on the role of each particular element and would actually depend on the element performing the primary action. In general, this category includes three main types of devices:
- Devices used to administer medicinal products (including the devices that could be refilled) – should be subject to regulation under the MDR.
- Devices for administering medical products that could be used only in the particular combination with medicines and could not be refilled or reused – should be regulated under medicines legislation.
- Devices containing a substance that is a medicinal product – should be regulated under the MDR. In accordance with the classification rules, such devices should be assigned to Class III, providing that notified body would have to perform conformity assessment procedures in the course of the marketing authorization process.
The guidance also provides a detailed list of products that potentially could fall within the borderline category. (together with the indication of correct determination of such products and additional rules to be applied in certain cases.) The list covers contact lens care products, other ophthalmic products, surgical dressing, non-medicated dermatological creams, sutures and ligatures, resorbable bone plates, hard tissue scaffolds, soft tissue fillers, bone cement, joint replacements, inhalation products, powered nebulizers and other categories of products.
Summarizing the information provided, the guidance issued by the MHRA already covers the most important aspect related to the determination of borderline products in general and distinguishing criteria of medicines and medical devices in particular.