Frequently Asked Questions

Medical Device – indicates the product fulfils the criteria of a medical device, i.e any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Unique Device Identifier – the UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI.

European Conformity Mark – is an identification that the product conforms to European Medical Directive 93/42/EEC, and Medical Devices Regulation (EU) MDR 2017/745 and meets applicable health, safety and environmental requirements. At this form it appears only on non-sterile products.

European Conformity Mark with Notified Body Number – is an identification that the product conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and environmental requirements. For sterile products the symbol is accompanied by the notified body number.

UK Conformity Assessed – marking is a conformity mark that indicates that the product conforms to the UK Medical Device Regulations (UK MDR 2002), this regulation specifies the requirements that legal manufacturers of medical devices must meet to legally place a device on the UK market. At this form it appears only on non-sterile products.

UKCA mark with Notified Body Number – marking is a conformity mark that indicates that the product conforms to the UK Medical Device Regulations (UK MDR 2002), this regulation specifies the requirements that legal manufacturers of medical devices must meet to legally place a device on the UK market. For sterile products the symbol is accompanied by the notified body number.

Manufacturer – to comply with regulatory requirements for medical devices, each level of packaging has to bear the name and address of the manufacturer.

Date of Manufacture – is an identification the date when the medical device was manufactured, expressed as YYYY-MM-DD on every level of packaging.

Batch Code or LOT Number – is an identification number assigned to a particular quantity or a material from single manufacture. Lot numbers can be found on the outside of packaging.
The lot number enables tracking manufacturer ingredients, labour and equipment records involved in the manufacturing of products. This can help manufacture to perform quality checks and expiration dates.
This number gives customer an identifier that they can use in contacting the manufacturer and researching the production of goods received.

Use by Date – is an identification that the medical device should not be used after the date accompanying the symbol. This symbol should be expressed as YYYY-MM-DD on every level of packaging.

European Authorised Representative – it is a legal requirement for manufacturer who places a device on European Union market under their own name to appoint a European Authorised Representative (EC Rep) that provides a point of contact between manufacture (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.

Latex Free – is an identification that the product is not made from natural rubber latex or doesn’t contain any natural rubber. This information is essential for customers having an allergy reaction to latex.

Do Not Reuse – is an identification that the product is intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of.

Sterile – is an identification that the product is provided sterile and has been sterilised.

Sterile Using Ethylene Oxide – is an identification that the product is provided sterile and has been sterilised using ethylene oxide.

Non Sterile – is an identification that the product has not been subjected to a sterilisation process.

Single Sterile Barrier System – is an identification that the product has single sterile barrier system.

Single Sterile Barrier with Protective Packaging Inside – is an identification that the product has single sterile barrier system with protective packaging inside.

Do Not Resterilize – is an identification that the product is not to be resterilized.

Caution – essentially a cautionary symbol and should be used to highlight the fact that there are specific warnings or precautions associated with the product, which are not otherwise found on the label.

Recycling – is an identification that the product is capable of being recycled, not that the product has been recycled or will be accepted in all recycling collection systems.

Keep Dry – is an identification that the product should be kept away from rain and in dry conditions.

Keep Away from Sunlight – is an identification that the product should not be exposed to sunlight.

Do Not To Use if Package Is Damaged – is an identification that the product must not be used if the package holding the product is damaged. Damaged package can disintegrate of the contents or the continuity of their special condition (such as sterility) is compromised if the package bearing the symbol is damaged or prematurely opened.

Consult Instructions for Use – is an identification on product or product packaging that relevant information for use of the product is available in printed paper form.

Upper Limit of Temperature – is an identification that the product has the maximum temperature limit at which the item should be stored, transported or used. The temperature values may be indicated adjacent to the symbol with the maximum temperature at the upper right.

Absence of Phthalates – phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices.