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Clarity will promote quality
The regulations governing medical devices are being further tightened this spring. The new rules will supplement and further clarify the already existing regulations. One point that is being particularly emphasised is how clinical evaluation of medical devices should be carried out and documented.
It was after an assessment of the regulations governing medical devices that shortcomings within three major areas were discovered, one of which constituted the clinical evaluation. The fact is that despite joint EU directives, there was considerable variation in the relevant clinical data for verification of product performance. In some cases, there was no clinical evaluation at all, and in others it was poorly executed. In order to ensure the quality of medical devices within the EU, more clear-cut demands are now being imposed requiring manufacturers to carry out clinical evaluation of their products.
 
The new rules have already been included in Swedish legislation and will come into force on March 21 this year. The requirement in itself is nothing new, but it is being further clarified by being included as an independent point in its own right as part of the already existing main body of requirements in the current body of regulations. The detailed documentation of the product´s clinical data must also be updated with the help of reports from the market.

On the pan-European level major clinical trials, which take place in several EU countries, must be entered in the European database, EUDAMED. The idea is that EUDAMED should serve as an operations centre and that the various countries should enjoy systematic exchange of information about clinical trials and thus be able to alert one another more quickly in the event of problems. In addition, public authorities will have access to this database so that certification denied in one instance can be seen by other authorities. In this way, the procedures for clinical trials of medical devices will more closely resemble the procedures governing pharmaceutical testing.

Source: Biotech Swedenexternal link, opens in new window

EUDAMEDexternal link, opens in new window

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