Regulation

Views on the rules and regulations that govern medical technologies.

Posted on 28.04.2014

Clinical Evidence “for In Vitro Diagnostics” should be exactly that: “for IVDs”

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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Posted on 26.02.2014

Where are we again on the MDD and IVDD?

Where are we again on the MDD and IVDD?
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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Posted on 29.01.2014

“Harmonised” data protection in the EU: a new barrier to patient access to medtech?

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By Chantal Vets, Senior Legal Director, Medtronic

Posted on 27.11.2013

Hats off to policymakers for encouraging multidisciplinary wound care

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By Paul Trueman, Chair, Eucomed Advanced Wound Care Sector Group; Vice-President of Market Access Smith & Nephew

Posted on 22.11.2013

Regulations, assessments – in the end it’s about patients’ access to therapies

EU regulations
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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Posted on 16.10.2013

Always read the small print…on the ENVI proposal for the reprocessing of single-use medical devices

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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Posted on 15.10.2013

Beyond rhetoric: MEPs need facts to make an informed decision on medical devices regulation

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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Posted on 12.09.2013

Pacing the implementation of the new IVD regulations

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By Jesús Rueda Rodríguez, Director International Affairs MedTech Europe

Posted on 31.07.2013

Are human genes patentable in Europe and the US?

Genes
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By Morag Peberdy, Of Counsel, Covington & Burling LLP

Posted on 10.06.2013

Specific Biological Properties Distinguish In Vitro Diagnostics

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By Maurizio Suppo, EU IVD Representative at Assobiomedica

Posted on 02.05.2013

Eurasian Economic Integration – market opportunity or regulatory challenge for the MedTech industry?

Eurasia
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By Diana Kanecka, Regulatory Affairs Intern, EDMA

Posted on 29.04.2013

The reasoning behind the “Don’t lose the 3” campaign

Don't lose the 3
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By Ingmar de Gooijer, Director Communications, MedTech Europe

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