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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EUDAMED Actor Registration Module LIVE!

The European Commission launched the EUDAMED Actor Registration Module. Manufacturers, Authorised Representatives and/or Importers can now register in EUDAMED and obtain their Single Registration Number (SRN).

MDCG Guidance on IVDR Classification Rules released!

On 13 November 2020, the European Commission released MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR).

Qarad opens new company in UK

The United Kingdom leaves the European Union on January 1, 2021. As regulatory experts, Qarad is ready to assist the Medical Devices and In Vitro Diagnostic industry through this change. With the establishment of Qarad UK Ltd., the fourth Qarad office, Qarad can now also function as UK Responsible person.

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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ISO 13485 and ISO 27001

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