06:09
Faizan
We all realise the importance of having a regulatory framework for medical devices. Medical products must be in line with certain directives so that private companies do not exploit the market with inferior and often unsafe products. Medical equipments are constantly improving along with new technological updates offering the industry superior products every year. This is a rapidly evolving field and the marketing of these devices is very profitable indeed. However, what about regulations? Where are we now with the medical devices regulatory framework?
The European Union has set aside three mandatory directives for medical equipment. These directives ensure the safety and the health of the public when exposed to these medical products. Any device that compromises public health is not acceptable and will not be certified for marketing to hospitals and the medical fraternity. Even implantable medical products come under this purview. The recent scare regarding breast implants is a case in point. The medical devices regulatory commission has also included diagnostic medical equipment under the directives so that these devices adhere to certain mandatory levels of performance. The in vitro medical products have been of particular concern to the regulatory commission. All these directives were given a legal framework and they came into effect after 1990. Over the years, various modifications and additions have been made to this framework. The latest changes were made in 2007. Steps have also been taken to ensure the implementation of these directives.
The regulatory commission has also issued guidance documents so that private companies manufacturing products and marketing them do not default on these directives. These guidance documents are legally non-binding. However, these documents help to implement these strict and evolving directives.
In recent years, it was felt that a revision of the legal framework was required and so in 2008 there was a public consultation on carrying out such revisions. Then in 2010, another public consultation was held by the regulatory commission to oversee changes and revisions regarding in vitro diagnostic medical devices. This last consultation was mainly regarding the technical aspects of in vitro diagnostic medical devices.
The European Union has set aside three mandatory directives for medical equipment. These directives ensure the safety and the health of the public when exposed to these medical products. Any device that compromises public health is not acceptable and will not be certified for marketing to hospitals and the medical fraternity. Even implantable medical products come under this purview. The recent scare regarding breast implants is a case in point. The medical devices regulatory commission has also included diagnostic medical equipment under the directives so that these devices adhere to certain mandatory levels of performance. The in vitro medical products have been of particular concern to the regulatory commission. All these directives were given a legal framework and they came into effect after 1990. Over the years, various modifications and additions have been made to this framework. The latest changes were made in 2007. Steps have also been taken to ensure the implementation of these directives.
The regulatory commission has also issued guidance documents so that private companies manufacturing products and marketing them do not default on these directives. These guidance documents are legally non-binding. However, these documents help to implement these strict and evolving directives.
In recent years, it was felt that a revision of the legal framework was required and so in 2008 there was a public consultation on carrying out such revisions. Then in 2010, another public consultation was held by the regulatory commission to oversee changes and revisions regarding in vitro diagnostic medical devices. This last consultation was mainly regarding the technical aspects of in vitro diagnostic medical devices.
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