In our everyday lives, we often think of physical medical products. But what about the digital side of medicine? Discover why we should take medical software seriously and what questions you need to ask yourself.
Medical software - don't take it easy
In our everyday lives, we have a lot to do with hardware, with " physical" medical devices. It is (now) firmly established in everyone's mind to ask ourselves the questions:
- Do I have a medical device in accordance with MDR Article 2 (1)?
- Which class does my medical device belong to according to MDR Article 51 or Annex VIII?
- Which conformity assessment procedure according to MDR Article 52 do I have to undergo as a manufacturer?
In the case of medical software, this is often viewed somewhat more relaxed. However, just like hardware, medical software falls within the scope of the MDR (Medical Device Regulation) and just like hardware, the questions mentioned above must be asked, answered and appropriate measures taken. For medical software, there is classification rule 11 in MDR Annex VIII, according to which medical software in particular is classified. This results in the required conformity assessment procedure with or without a notified body.
The Hanseatische Oberlandesgericht (OLG) Hamburg hat das Ende Juni in einem Urteil für ein telemedizinische Medizinprodukt richtungsweisend unterstrichen. Demnach muss ein Software-Produkt mit medizinischer Zweckbestimmung als Medizinprodukt nach genannten Regeln betrachtet werden und wenn es wie in diesem Fall der Risikoklasse IIa zugehörig ist, auch das entsprechende Konformitätsbewertungsverfahren mit einer Zertifizierung durch eine benannte Stelle durchlaufen, um in Verkehr gebracht werden zu dürfen.
In the case in question, a dispute between competitors was decided in favour of the appellant. The defendant must now withdraw its medical software from the market until the necessary technical documentation in accordance with the MDR has been created, the quality management system has been implemented and certification by a notified body has been completed.
The disputes, costs and delays are avoidable. The application and interpretation of the requirements is not always easy for the inexperienced and this is where we are here to help you. From simple information to the complete takeover of the conformity assessment procedure, we put our many years of expertise at your service. Please contact us, we will be glad to support you.
(3 Rating(s), average: 5.00 out of 5)
Loading...
