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New Borderline Guide concerning medical devices issued by the MHRA

20 February 2014
On 5 February 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance document[1] intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices.

In its guidance, the MHRA underlines that a product will be considered to fall within the definition of a medical device if it has a medical purpose and if the product functions primarily in a way that is not metabolic, immunological or pharmacological. Determination of whether a product is considered to have a medical purpose will be based on its intended purpose. This is defined by the manufacturer in the device labelling, Instructions For Use and promotional materials. To illustrate this understanding, the MHRA provides examples of words and phrases which, in the past, were likely to have contributed to a determination by the Agency that a product was a medical device. This includes claims such as "can benefit those who suffer from", "protects against", "repairs", "compensate for" or "eases symptoms". These examples can be found in the appendix to the guidance.

On the basis of these criteria, the MHRA provides examples of products which generally fall within the definition of a medical device and products which are usually excluded from this definition. The guidance document covers a wide range of categories such as products for cosmetic or toiletry purpose, products for sports and leisure, personal protective equipment, software and spare parts.

According to the guidance, products that have multiple purposes and which may occasionally be used within a medical environment are not normally medical devices unless a manufacturer ascribes a specific medical purpose to such products. This would be the case of a multipurpose PC, scanner or printer which can be used for multiple purposes.

In the case of equipment intended to alleviate, or compensate for a disability, the determining factor will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned. In addition, the equipment must have a stated medical purpose. The MHRA considers that hearing aids or baths with integral hoists meet these criteria and generally fall within the definition of a medical device.

The MHRA further clarifies that raw materials, component parts, or products at stages of intermediate manufacture are not normally considered to be medical devices. However, these products may have properties or characteristics which will affect the quality and safety of finished medical devices. Manufacturers must, therefore, draw particular attention on the selection and control of these raw materials, or component parts to ensure their compatibility with the finished medical device.

At the end of the guidance document, the MHRA provides a list of guidelines published by the Agency and the European Commission which should be used by manufacturers to determine whether their products can be considered as a medical device in the EU.

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