[Close Article]EU moves to improve safety of medical devices
The safety of medical devices such as surgical equipment or implants is to be significantly improved after the adoption of a proposal by the European Commission, today by the European Parliament. There will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required. Furthermore the safe single use of devices is enhanced. A study will be done to see how better reprocessing of devices can be achieved. Apart from this, specialized medical software will fall under the scope of the new Medical Device Directives, which have been updated in the light of new technological developments. The European Parliament vote is based on a compromise, reached with the Council, which is expected to adopt the package shortly.
Commenting on the vote, Commission Vice-President Günter Verheugen, responsible for enterprise and industry policy, stated: "This is good news, as today's vote allows for enhanced patient protection and supports medical progress and innovation. It will improve the functioning of the internal market, and strengthen the competitiveness of European industry."
Medical devices have become an increasingly important health care sector and have an increased impact on health and health care expenditure. Medical devices encompass some 10,000 types of products, ranging from simple bandages and spectacles, through life sustaining implantable devices, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. The public expects that such medical devices meet the highest safety standards.
The new legislation will clarify essential elements for safety of medical devices such as clinical evaluation and conformity assessment, as well as bringing new, positive, provisions such as those aimed at increasing transparency. The package agreed today aims at reinforcement in the following fields:
- To bring clarification to the area of reprocessing of medical devices, the definition of the term 'single use' and subsequent labelling will be uniform within the EU;
- Manufacturers should avoid the use of carcinogenic, mutagenic or toxic to reproduction (CMR) substances used in medical devices. A total ban of these substances is not possible without banning many medical devices which are indispensable for the protection of health. But the following improvements are foreseen:
- Devices which could possibly release phthalates to the body of the patient should be labelled accordingly.
- Manufactures should strive at developing alternative substances or products with a lower risk potential.
- It is necessary to clarify that software, is in its own right a medical device, when specifically intended by the manufacturer to be used for diagnostic or therapeutic purposes, for instance to assist people who have suffered from a brain haemorrhage. Software for general purposes when used in a healthcare setting is not a medical device.
- The issue of the medical devices combined with cells and tissues of human origin, the so called "combined products" will not be tackled. Other planned legislation should deal with this question, such as the Regulation of advanced therapy medicinal products.
- As design for patient safety initiatives, the manufacturer should place particular emphasis on the working environment in which device is used and possible reduction of potential accidents.
Additional information, including the Commission proposal, can be found at:
http://ec.europa.eu/enterprise/medical_devices/revision_mdd_en.htm
