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Highlights

December 06, 2021

Global Implementation of the Unique Device Identification (UDI) for Medical Devices

As you may all know, barcodes on medical devices are not something new. For example, in 2008 Japan’s MHLW has issued the “Guideline for Barcode Labeling of Medical Devices” and the European Commission has adopted UDI as a part of the European Medical Device Regulation (2017/745) in 2017. Since that time, a lot of useful UDI-related guidance documents were issued by EU Commission for industry.

Medical Device Regulations UDI

October 14, 2021

MDCG 2021-24 Guidance on classification of medical devices

We have been longing for it since the MDR was first published and now eventually some guidance on device classification is available. Was it worth the wait? Well, to some extent it was.

MDCG Medical Device Regulations Highlights

Results

January 18, 2022

Understanding the IVDR Transition - There's still a lot of work to do

The new In Vitro Diagnostics Regulation (IVDR) transitional arrangements have now been published to the great relief of all stakeholders.

Blog In-Vitro Diagnostics IVDR

January 17, 2022

Kristiane Schmidt joins Qserve

Qserve Group is pleased to announce that Kristiane Schmidt has joined our team to further expand her capabilities in supporting our IVD team and IVD’s manufacturers worldwide.

Clinical Trials In-Vitro Diagnostics ISO 13485:2016 ISO 14971 IVDR Qserve Team Risk Management

January 06, 2022

Clinical Trials Regulation (CTR) for medicinal products in application on 31 January 2022

Relevant news for the those medical device manufacturers who also have pharmaceutical products: by the end of this month, on 31 January 2022, the pharma Clinical Trials Regulation (CTR) EU 536/2014 comes into application.

Clinical Trials

December 17, 2021

Happy Holidays and Best Wishes for 2022 from Qserve Group

This time of year is always extremely busy. Somehow we all feel pressure to finish things before we can start a well-deserved Christmas break.

Medical Devices MedTech Qserve Group

December 17, 2021

BREAKING NEWS - Amendment to the IVDR transitional arrangements adopted

I am delighted to tell you that the proposal to amend the transitional arrangements of the IVDR and defer the application of some of the in-house requirements has been adopted.

In-Vitro Diagnostics

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