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
No-deal Brexit Impact.

The European Commission has posted on their website a Questions and Answers related to the UK’s withdrawal from the EU, in case of a no-deal scenario. While in the UK, new regulations that amend their 2002 Medical Device Regulations were laid down in parliament.

TOPRA IVDR Masterclass - February 2019
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Qarad's Vice-President was invited to speak at TOPRA's IVDR Masterclass in London on February 20-21, 2019!

EU Commission publishes new MIR template

The new template for a Manufacturer Incident Report (for MDD/AIMDD/IVDD incidents or MDR/IVDR serious incidents) was published, along with a help text on how to complete the new form.

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