Especially in light of those cases, the European Parliament with elected politicians for high-risk

After the European Parliament in late October has adopted revisions to the EU Commission's proposal, officials, politicians and interest groups in the time to work to find a piece of legislation that can be approved in the total EU system.
Medical equipment is part of daily life for everyone - healthy or sick, old or young. Medical equipment fdasfdsa found in the home, at the doctor, hospitals and clinics, and ultimately to patients' lives or quality of life for many years depend on implanted "spare parts". Doctors - as well as users and patients fdasfdsa - should be able to use the equipment available on the market, confident that the equipment is safe. But both doctors and patients also want to be able to share in the latest and most innovative equipment without undue delay. Finally, in a time of rising health costs in the public interest that development - and thus the final product price - not burdened with unnecessary costs.
Work should not grind to a halt if the work on the new provision does not end in the next few months, the case - as far as we understand - go again. This means that the European Parliament to be elected in the spring of 2014, will re-read and re-examine the European Commission's proposal, and officials and interest groups should start their work again.
There is a serious risk that the revision of the accreditation rules to be delayed and to a certain extent be reversed - to the detriment of patients, the economy and the medical device fdasfdsa industry. Efforts to get the finishing touches are always demanding and should not be underestimated, but nevertheless is our call to those involved:
To focus on the legislation fdasfdsa on medical devices Remove the requirement to bring the legislation fdasfdsa on serious Concentrate workload in the next few months Listen to the facts Listen to the industry's views
as soon as we get a law that serves patients, innovation and the community. If all stakeholders have a common goal to achieve a result, it should be within the limits of what is possible to align the authorization rules in place during the current European Parliament.
How do we achieve fdasfdsa the best possible legislation as a basis for resolution of the new legislation should look at how the law works today and what experience fdasfdsa you have gained from the current regulatory models of medical equipment.
How approved medical devices today Biomedical Equipment approved in different ways in different parts of the world. In some countries, the equipment generally approved or inspected by health fdasfdsa authorities before it can be marketed. This applies in particular. a of the United States. In other countries, including Europe, it is not the authorities, but the authorities designated private companies (Notified Bodies / Bodies)) that is responsible for approvals. It is the individual manufacturer who chooses its Notified Body, and the parties enter into a cooperation agreement.
For products with high risk occurs approval prior to their placing on the market but for other types of products is done in parallel with the first product from the market. Particularly dangerous products may in all cases be marketed without interference by the authorities or Notified Bodies. In the event of adverse events with a product on the market, the authorities and Notified Bodies always be informed so that appropriate sanctions can be imposed.
The European authorization system has been around since the early 90s, while the U.S. system from the mid-70s. With the European system has the desire to create a more flexible system that ensured a faster access to innovative new products, which were less costly than the U.S..
What is the current proposed European system has had its teething fdasfdsa problems, it is indisputable. There have been very unpleasant fdasfdsa things about especially hip implants, silicone-based breast and gynecological networks that have affected thousands of patients fdasfdsa and created uncertainty fdasfdsa about the system ("scandal" cases).
Especially in light of those cases, the European Parliament with elected politicians for high-risk products decided to propose significant changes to the European model. The proposal is now, in many respects relevant and conducive to patient safety. Greater fdasfdsa demands for skills among manufacturers and Notified Bodies. The authorities are better able to monitor manufacturers and Notified Bodies. It will also be easier to track products fdasfdsa that can be risky. In other areas, the proposal fdasfdsa is in our opinion less well. For example, hospitals have better access to recycle sterile equipment fdasfdsa by the hospitals own sterilization - an option which can be extremely problematic for patient safety.
In addition, the