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News from the UK

The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After the deadline UK will be considered a third country if no deal is made. This article explains what to expect when bringing your medical device to the UK market….
Switzerland

News from Switzerland

In Switzerland, just as elsewhere, ‘Europe’ and immigration are closely connected topics. The right wing political party is very vocal in its campaigning to reduce the numbers of foreign workers and to restrict the movement of foreigners across the border….
Qabc

NEW – The Qmed Academy Book Club

Important new MDCG guidelines are released from the European Commission. These are importance guidance documents for all of us working within developing and selling medical devices…
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How to Spend the Time

Several guidance’s, posts, webinars have been published addressing what evidence collection due to the COVID-19 pandemic, and with this Newsletter we are publishing where to find the different national guidelines and recommendations. Additionally, the MDR Amendment allow us to reconsider our strategies and potential scenarios. In this article…
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MDCG Guidance

The pandemic COVID-19 has resulted in various restrictions to countries around the globe. It has affected the ability of notified bodies to conduct mandatory on-site audits under the medical device legislation. The World Health Organization has published guidance on temporary extraordinary measures, which are related to medical devices, Notified Body audits during times of COVID-19. It allows continued availability of safe medical devices to the market and…
Covid

Covid-19: Letter from Qmed management

As the impact of COVID-19 intensifies globally, governments and healthcare systems come under extraordinary pressure. And healthcare professionals are holding the front line to save lives…
Sum

Sum up of the new MDR amendment from The European Parliament

While we are waiting for the MDR amendment to be discussed and agreed upon by the European Parliament and the Council hopefully before end May through an accelerated co-decision procedure lets try and sum up what it could mean for manufacturers of medical devices (note: As for the In Vitro Diagnostics Regulation (IVDR), which will be applicable from 26 May…
14155

The revision of ISO 14155 is available

The final draft of the new third edition of the ISO 14155 is being prepared for circulation. This means that at the present stage, only editorial changes are permitted, and therefore this draft version can be used by sponsors designing clinical investigations of medical devices…
Healthcare

As healthcare professional or institute – what does the new medical device regulation change for you?

The publication of the MDR in May 2017 marked the start of a 3 year period of transition from the MDD and the AIMDD. During the transition period the Regulations will come into force gradually, starting with provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the Regulations…