EC Calls for Improved Safety of Medical Devices

March 29, 2007 // Published as a news service by IHS

EC's proposal calls for stricter rules on the use of potentially toxic materials, for which adequate labelling will be required. The proposal also enhances the safe single use of devices.

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's vote is based on a compromise, reached with the European Council, which is expected to adopt the package shortly.

EC vice president Günter Verheugen, who is responsible for enterprise and industry policy, said, "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 part of the health care sector and have a growing impact on health care expenditures. 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 today's medical devices to meet the highest safety standards.

The new legislation will clarify essential elements for medical device safety, such as clinical evaluation and conformity assessment, as well as bring new, positive provisions, such as those aimed at increasing transparency.

The new proposal that was agreed to on March 29 aims at reinforcing the following issues:

• Clarification needs to be brought to the area of medical device reprocessing and the definition of the term "single use." In addition, subsequent labelling should be uniform within the European Union (EU).
• Manufacturers should avoid the use of carcinogenic, mutagenic or toxic-to-reproduction (CMR) substances used in medical devices. However, a total ban of these substances is not possible without banning many medical devices that are indispensable for the protection of health.
• Devices that could possibly release phthalates to a patient's body should be labelled accordingly.
• Manufacturers should strive to develop alternative substances or products with a lower risk potential.
• Software needs to be viewed as a medical device when it is specifically intended by the manufacturer to be used for diagnostic or therapeutic purposes - for instance, to assist people who have suffered from a brain hemorrhage. However, software that is used for general purposes within a health care setting is not a medical device.
• The issue of medical devices combined with cells and tissues of human origin - the so-called "combined products" - will not be tackled by this proposal. Other planned legislation should deal with this question, such as the regulation of advanced therapy medicinal products.
• As regards patient safety initiatives, the manufacturer should place particular emphasis on the working environment in which a device is used and on the possible reduction of potential accidents.

Additional information can be found on the web page for the Proposed Revision of the Medical Device Directives.

Source: European Commission.