Essays about: "Regulation EU 2017 746"

Found 2 essays containing the words Regulation EU 2017 746.

1. 1. Approved medicinal products with potential companion diagnostic tests : An Inventory of the Swedish/European drug market

   University essay from Uppsala universitet/Institutionen för farmaceutisk biovetenskap

   Author : Katrin Andersson; [2023]
   Keywords : CDx; Companion Diagnostic; IVDMD; In-vitro diagnostic medical devices; Regulation EU 2017 746;

   Abstract : The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. READ MORE

3. 2. Traceability of Medical Devices Used During Surgeries : A Study of the Current Traceability System at the Karolinska University Hospital in Solna and Research of Improvement

   University essay from KTH/Medicinteknik och hälsosystem

   Author : Charlott Danko; [2020]
   Keywords : ;

   Abstract : The last few decades' development of technology has greatly affected healthcare. The implementation of technology in healthcare has advanced and improved it immensely, but it has also brought a new level of complexity. One of the modern issues introduced to healthcare is the traceability of medical devices. READ MORE