With advancements in medicines and even medical equipment, there is more and more news coverage is dedicated to bringing us up to date information. A term or phrase often mentioned is medical devices directive. Often being used in conjunction with a new product it begs the question as to what exactly the directive does and what part does it play in product development. Here is some information regarding the directive that you might not currently be aware of:
What does the directive cover?
The directive was established in 1993 and was developed with the intention of bringing stability across the board of medical devices and how they are brought to market. The medical devices directive covers a whole range of products including but not exclusive to x-ray equipment, bandages, dental products, ECG and prosthetics. Since its introduction the medical devices directive has been amended several times in accordance with medical advancements and new product boundaries.
How Do You Comply With The Medical Devices Directive?
When bringing a new product to market it's important that it falls in line with the directive or it will not be approved for sale. There are many criteria that need to be met and they essentially come down to very stringent guidelines. It's important that a thorough risk management process is carried out and all positive and negative eventualities are evaluated. The product or device must be thoroughly checked to see if it poses any bio hazard danger, electric or electromagnetism readings that would makes its correct use potentially unsafe. The product must also be developed in a sterile environment and packaged in a sterilised way ensuring its use doesn't cause infection. One of the final and most important points stipulated by the directive though is that all devices should be clearly labelled and proper instructions for their correct use included, including warnings and advice should they be used incorrectly.
Why Do We Need The Medical Devices Directive?
Understanding more about the directive and the diverse areas the directive covers certainly starts to put together a good solid case as to why it is needed. If you consider all the medical devices out there, whether you're talking about dentistry or heart surgery knowing that the products have been regulated and checked over thoroughly.
It's reassuring to know that the directive exists and that it has brought a unified set of rules and procedures to a growing and rapidly changing market place.
What does the directive cover?
The directive was established in 1993 and was developed with the intention of bringing stability across the board of medical devices and how they are brought to market. The medical devices directive covers a whole range of products including but not exclusive to x-ray equipment, bandages, dental products, ECG and prosthetics. Since its introduction the medical devices directive has been amended several times in accordance with medical advancements and new product boundaries.
How Do You Comply With The Medical Devices Directive?
When bringing a new product to market it's important that it falls in line with the directive or it will not be approved for sale. There are many criteria that need to be met and they essentially come down to very stringent guidelines. It's important that a thorough risk management process is carried out and all positive and negative eventualities are evaluated. The product or device must be thoroughly checked to see if it poses any bio hazard danger, electric or electromagnetism readings that would makes its correct use potentially unsafe. The product must also be developed in a sterile environment and packaged in a sterilised way ensuring its use doesn't cause infection. One of the final and most important points stipulated by the directive though is that all devices should be clearly labelled and proper instructions for their correct use included, including warnings and advice should they be used incorrectly.
Why Do We Need The Medical Devices Directive?
Understanding more about the directive and the diverse areas the directive covers certainly starts to put together a good solid case as to why it is needed. If you consider all the medical devices out there, whether you're talking about dentistry or heart surgery knowing that the products have been regulated and checked over thoroughly.
It's reassuring to know that the directive exists and that it has brought a unified set of rules and procedures to a growing and rapidly changing market place.
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