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Claim handling

Guidelines on how to get your claim resolved

You are experiencing difficulties with one of our products? We are very sorry to hear that, in fact we want to know more about what you are not happy with. On this page you will find everything you need to know about claim handling at Sempermed. 

Claim handling according to MDR

Because of the transition to a new Medical Device Regulation (MDR), the claim handling process has not only become increasingly important to us as a manufacturer, but also to you, our distribution partners and end users. Both MDD as well as MDR state that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. However, MDR puts much more emphasis on the whole topic of post market surveillance, which includes handling of complaints as well as reportable event.

In order to guarantee a smooth and structured process, we kindly remind you to include the following information when submitting a claim:

For customers

  • Glove type (e.g., Sempercare® Velvet)
  • Exact description of believed defect (e.g., hole in the glove, location, size)
  • LOT number (include complete number on dispenser, e.g., for exam: 2020-02 L045814; surgical: 20 H 0211)
  • If possible, please provide required minimum quantity of believed defective product (include company specific claim number)
  • Used on patient (yes/no)
  • Event reported to authority (yes/no)
  • If skin irritation occurred -> irritation questionnaire shall be completed in addition
  • Pictures of defective dispenser boxes and/or gloves

For distributors

  • Ensure completeness of incoming claims (items on above list must be included)
  • Ship samples to:
    • Semperit Technische Produkte GmbH
      DM /QW department
      Ms. Celik Duygu
      Triester Bundesstraße 26, 2632 Wimpassing, Austria 
  • Shipment of samples and claim notifications to be made on a timely basis, information regarding potentially reportable events need to be forwarded immediately
  • Samples to be send on customer expenses to Austria

Please proceed provide all the necessary information so we can process your request as soon as possible. 


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