The MHRA has recently released guidance to assist with the process of identifying whether a product is a ‘general medical device’ within Part II of the UK Medical Device Regulations 2002 (UK MDR 2002). Particularly with borderline cases, just because a product is or is not a general medical device in another jurisdiction, it does not mean the same position will apply under the UK MDR 2002.
At a high-level, general medical devices are products that are intended by the manufacturer to be used in a ‘medical’ context. To be a general medical device, a product must also act primarily in a way that is not metabolic, immunological or pharmacological (otherwise they will likely be regulated under legislation covering medicinal products instead).
There are many areas where confusion regularly arises and the MHRA has sought to provide clarification, including:
- Medical / cosmetic purposes - NOT medical devices if the ‘medical purpose’ is secondary (for example, insect repellents, toothbrushes, hot water bottles), but can be a medical device where there is a specific primary medical purpose (such as external heat pads claiming pain relief or muscle toning products with medical claims);
- Multi-purpose products - NOT generally medical devices if there are multiple purposes (for example, disinfectants);
- Products for sports and leisure - NOT generally medical devices unless specific claims are made for the treatment of pain or injury (for example, support bandages);
- Personal protective equipment - NOT generally medical devices where designed to product the user, but do act as medical devices where designed to protect the patient
- Software - can be a medical device, regardless of whether standalone or intended for combination use (for example, software intended to enhance images from x-rays or ultrasounds); and
- Raw materials/components - NOT usually medical devices, as a medical purpose will relate to the finished product.