In Vitro Diagnostics and Medical Devices

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CE Marking – Quality Systems – Risk Management
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E-Labeling / eIFU

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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.

Online PRRC Training

Qarad organizes online webinars to prepare you in your future role as Person Responsible for Regulatory Compliance

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.

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.

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).

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.

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