In Vitro Diagnostics and Medical Devices

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E-Labeling / eIFU

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The added value of Qarad’s multilingual freephone service to their eIFU solution

Government regulations for MD and IVD products allow manufacturers to provide IFUs digitally in the form of portable electronic storage media (e.g. CD or USB) or via the company’s website. Although these digital IFUs are allowed, the manufacturers are still obliged to provide an alternative means so clients can obtain paper copies on request. Qarad’s free telephone service guarantees quick and efficient handling of these requests without any burden to the manufacturer.

New MDR and IVDR harmonised standards published!

Commission Implementing Decisions (EU) 2022/6 and 2022/15 as regards to harmonised standards, for MD and IVD respectively, were published in the Official Journal of the European Union (OJEU).

Progressive roll-out of IVDR adopted!

The European Parliament and Council adopted the European Commission’s proposal for a progressive roll-out of the IVDR without any changes. This amending Regulation does not change any requirements of the IVDR in substance but only changes the transitional provisions stipulated in Article 110, to allow a progressive rollout.

New MDCG Guidance documents released!

New guidance documents were released by the Medical Device Coordination Group. They provide clarification on requirements for “legacy devices”, repackaging & relabelling activities and provides guidance with regards to substantial modifications of clinical investigation under MDR.

Implementing Regulation eIFUs for Medical Devices!

December 14th, 2021, the European Commission issued the Implementing Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

Breaking: Qarad Joins the QbD group!

We are proud to announce that Qarad is now a part of the QbD Group. Joining forces with Quality by Design is a big new step in our own 21-year history. By combining forces within the QbD group, we will be able to assist clients in the full ‘from idea to patient’ life cycle even better.

QARAD BV

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ISO 13485 and ISO 27001

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