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New medtech regulations

MDCG Article 54(2)b interpretation of Regulation (EU) 2017/745

Posted on 02.04.2019

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Environmental and Social Sustainability

MedTech Europe publishes guidance on (Full) Material Declaration

Posted on 02.04.2019

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New medtech regulations

Medical device nomenclature for IVD Regulation (EU) 2017/746 and MD Regulation (EU) 2017/745

Posted on 02.04.2019

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Brexit

Impact of Brexit on Healthcare delivery in the European Union: MedTech Europe urges the Commission to take action

Posted on 08.03.2019

On 6 March, MedTech Europe sent open letters to the EU Commissioner for Health and Food Safety, Vitenis Andriukaitis, and to the EU Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, Elżbieta Bieńkowska to draw the Commission’s attention to the impact that the withdrawal of the United Kingdom from the European Union will have on the medical technology sector.

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Interactions with the Medical Community

“How to apply the MedTech Europe Code in France” – Register for a webinar for HCOs & PCOs in French

Posted on 01.03.2019

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New medtech regulations

New guidance documents from the Medical Devices Coordination Group

Posted on 28.02.2019

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Digital Health

MDR, Digital Health deployment in Europe & Regulatory compliance: check highlights of The MedTech Forum & GMTCC

Posted on 28.02.2019

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New medtech regulations

New version of the European Commission’ IVDR/MDR rolling plan

Posted on 28.02.2019

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Newsletter

Biotin interference in diagnostic tests

Posted on 28.02.2019

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New medtech regulations

New MTE discussion paper: Fit-for-purpose approach to biomarker assay deployment in medicinal product clinical trials

Posted on 28.02.2019

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International

EU-US trade talks: European Parliament Committee on International Trade (INTA) vote

Posted on 27.02.2019

On 19 February, the European Parliament INTA Committee (International Trade) voted in favour of the Commission proposed negotiating mandates on the trade talks between the EU and the US (21 in favour, 17 against, 1 abstention).

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International

EU-US trade talks: European Commission presents draft negotiating mandates

Posted on 30.01.2019

The European Commission has adopted proposals for negotiating directives for its trade talks with the United States. One on conformity assessment, and one on the elimination of tariffs for industrial goods.

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