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German Federal Joint Committee (G-BA) has requested manufacturers of extracorporeal shock wave therapy devices for heel pain to submit notifications about their technologies
Recently the Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation extracorporeal shock wave therapy in patients with heel pain. It was concluded that this method is superior to placebo, ultrasound and iontophoresis (see the summary of assessment here).
On 31st of May, the Federal Joint Committee (G-BA) requested manufacturers for notification of their devices for extracorporeal shock wave therapy before final decision will be given.
Relevant documents should be submitted by manufacturers for this purpose till 29th of June in electronic form by e-mail:
- The medical device certificate or the certificate of conformity of the medicinal product for placing on the market in Germany
- The technical instruction for use
Additionally, submission should include following statements:
- The description of device
- The description of the integration of device into method of treatment
- The purpose for which device has been placed on the market
See full request in German here.
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