ISO 13485 Medical Devices

The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the Health & Safety of the patient, user or any other person, and that any risks associated with the device are still compatible with patient health and protection. Devices that conform to these requirements are entitled to show the CE marking which allows the product to be freely available in the market within EU.

A Medical Device is defined in the Directive (93/42/EEC) as follows:
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or handicap.
• Investigation, replacement or modification of the anatomy or of a physiological process.
• Control of contraception.

The Directive divides devices into four classes:

• Class 1-Low risk
• Class 2a and 2b-Medium risk
• Class 3- High risk

In order to be able to apply CE marking to devices, companies must be assessed for compliance with ISO9000/EN 46000. EN46000 is the standard that gives the particular requirements for the application of ISO 9000 for Medical Devices.

Once a company has met the requirements of ISO 9000 and EN 46000 and has been assessed for compliance by an accredited body they may apply CE marks to the device. It is a requirement of the Directive that continued compliance is demonstrated through regular ISO 9000 and EN 46000 surveillance by the accredited Auditors.

All Medical Devices being marketed in the EU must bear CE marking.