The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is 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 (MDD).
In general, 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.
The MDD provides for several rules for the exact classification of a medical device. The Borderline Manual provides guidance concerning a broad range of “borderline” products such as water filters, shoe covers, radiation shields, fluid collection bowls and hand disinfectants.
The European Commission has updated the Borderline Manual with guidance concerning the classification of three products. The three products are automated external defibrillator storage units, lubricants for the alleviation of vaginal dryness and medication decisions support software.
Please contact our team if you have any questions about the classification of your medical devices.
The updated products
Automated external defibrillator storage units
Automated external defibrillator (AED) storage units are available in an increasing amount of different settings and locations.
The Borderline Manual provides guidance on the classification of a storage unit of an AED. Storage units can be classified as class I accessories to a medical device if they are intended to maintain the required environmental conditions for the AED.
Article 1.2 (b) of the MDD provides that an accessory to a medical device is:
“An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.”
The Borderline Manual provides, that, if the AED storage unit is not intended to maintain the required environmental conditions for an AED to perform as intended the storage unit should not be qualified as an accessory to a medical device.
Lubricants intended for alleviation of vaginal dryness
The Borderline Manual provides that water- or silicone- based lubricants intended for the alleviation of vaginal dryness during sexual intercourse should be qualified as medical devices.
The Borderline Manual provides that lubricants intended for the alleviation of vaginal dryness during sexual intercourse are invasive medical devices intended for short term use. Therefore, these lubricants should be classified in class I or IIa, depending on how long that the lubricants are expected or likely to remain in the body.
Medication decision support software
There use of software that is intended to be used by healthcare professionals to optimise the patient’s medicinal product intake is increasing exponentially.
The medication decision support software gathers data concerning the medicinal products that are to be administered to the patient. The medication decision support software could, for example, identify possible contraindications or provide warnings concerning possible interactions of medicinal products and suggest options to provide treatment for previously untreated conditions.
The Borderline Manual provides that medication decision support software falls within the definition of a medical device. This is because the medication decision support software is used for the purpose of prevention, monitoring, treatment or alleviation of a disease.
The purpose of prevention, monitoring, treatment and alleviation of a disease is one of the possible purposes of a medical device provided by Article 2 (a) MDD.
Software classified as a medical device is commonly referred to as medical device standalone software.