16 / 06 / 2021 What do Notified Bodies expect of your eIFU solution and its implementation? Implementing an eIFU solution in your company has major implications on your QMS. Notified Bodies will review how you handled the process. This article explainswhat you can expect. Read more »
16 / 06 / 2021 Regulatory focus: Impact of the latest rules for European IVD device manufacturers Dirk Stynen, Qarad's founder and President, was interviewed about the impact of the new IVDR on the field. Read more »
03 / 06 / 2021 Online PRRC Training Qarad organizes online webinars to prepare you in your future role as Person Responsible for Regulatory Compliance Read more »
22 / 05 / 2021 New MDCG Guidances released! New guidance documents were released to offer guidance on standardisation for medical devices, Q&A regarding clinical investigation under MDR , provide a notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 IVDs and clarifies clinical investigation application/notification documents. Read more »
18 / 05 / 2021 European Medical Device Nomenclature (EMDN) + UDI Helpdesk! May 4th, 2021, the first version of the European Medical Device Nomenclature (EMDN) was released by the European Commission and on May 18th, 2021 the UDI Helpdesk was launched. Read more »
12 / 05 / 2021 Swiss Third Country Status! A new Mutual Recognition Agreement between Switzerland end the European Union including MDR/IVDR remains outstanding. In addition, the ongoing negotiations between Switzerland and the EU for a transitional solution for MDD products have not yet been concluded, and have not yet resulted in any agreement. Therefore, all Swiss manufacturers and distributors of medical devices must be aware that as of 26 May 2021 they will have to comply with the requirements of a third country for all medical devices (MDR and MDD). Read more »
05 / 03 / 2020 Qarad's 5th IVDR Conference - Oct. 13 - 14, 2021 Due to the COVID pandemic, our annual conference was delayed with one year. In 2021, we are once again ready to inform you about the latest insights in the IVD Regulation 2017/746. Read more »
