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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News and Events
Implementing a Compliant Solution for Electronic Distribution of Instructions for Use

Read our online article regarding the eIFU implementation process

MDCG 2020-12 on devices incorporating a medicinal product!

MDCG released its guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues.

ISO Technical Report 24971:2020 Published!

The International Organization for Standardization (ISO) published the long-delayed Technical Report 24971, a companion document for the recently updated risk management standard ISO 14971.

MDCG Guidance on safety reporting in clinical investigations!

MDCG released a new guidance document and report form addressing how safety reporting in clinical investigations of medical devices should be performed under the MDR.

MDR officially delayed!

EU Regulation 2020/561 amending MDR 2017/745 on medical devices, as regards the dates of application of certain of its provisions, was published in the Official Journal of the European Union on 24 April 2020. 26 May 2021 is now the official date of full application of the EU’s Medical Device Regulation (MDR).

Qarad's 5th IVDR Conference - March 3 - 4, 2021

For the 5th year in a row, Qarad organizes a conference entirely dedicated to IVD Regulation 2017/746. Join us to get the latest insights and experiences

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