Classification of Medical Devices

Medical device classes fdating

The evaluation involvesThis is because phthalates can be

Classification of Medical Devices

Such cases may in particular include the determination of the borderline between two classes. Class I Medical Devices include tongue depressors, elastic bandages, hand held dental instruments and examination gloves. Class I devices present the lowest potential risk and do not require a licence. The clinical evaluation of the device needs to be continually reviewed after the device has been placed on the market. The data needs to adequately demonstrate that the product fulfills its intended purpose.

The technical documentation must cover all of the aspects listed below. The evaluation involves looking at published clinical data to prove that the medical device works as intended and is safe to use.

This is because phthalates can be carcinogenic, mutagenic or toxic to reproduction. The intended purpose includes any claims made as part of marketing material supplementary to those made in the technical file. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body.

One way of demonstrating that you meet specific essential requirements is by developing your product in accordance with relevant harmonised standards. This means products can be more precision-engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. Your review should take into account the outcomes of any post market surveillance activities or user feedback. You must do this before placing the device on the market.

The technical documentation must cover

It is recognized that although the existing rules will adequately classify the vast majority of existing devices, a small number of difficult cases may arise. Machinery Medical devices that are also machinery should also meet relevant essential requirements of the Machinery Directive. The first, and by far the most common is the so-called k process named after the Food, Drug, and Cosmetic Act section that describes the process. Description A general description of the product, including any variants for example names, model numbers and sizes.