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Regulation

Views on the rules and regulations that govern medical technologies.

Regulation Value of the Sector

Posted on 25.02.2013

Asking a butcher to bake bread makes no sense – so why ask EMA to approve medical devices?

Surgical devices

Prof. Mario Marazzi

By Mario Marazzi, Responsible Sanitary Service for Tissue Engineering Therapy. Regional Reference Center for in vitro human epidermis culture and tissue cryopreservation bank.

Regulation Value of the Sector

Posted on 22.02.2013

All about meetings and events these days: ENVI hearing, Personalised Medicine and the 2013 MedTech Forum

Time for revision

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By Serge Bernasconi, Chief Executive Officer, MedTech Europe

Regulation Value of the Sector

Posted on 20.02.2013

Understanding in Vitro Diagnostics & Why They Need a Separate Regulatory Framework

MaurizioSuppo-Photo

By Maurizio Suppo, EU IVD Representative at Assobiomedica

Regulation

Posted on 17.01.2013

The proposed scrutiny procedure: a measure proven to be ineffective in the world of pharma regulations

Medical technology regulation

Erik Vollebregt

By Erik Vollebregt, Life Sciences and IP Lawyer, and Founding Partner Axon Lawyers

Access Regulation

Posted on 21.11.2012

Industry involvement in EUnetHTA Joint Action 2 – Our experience is here for the taking

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By Vanessa Pott, EDMA Senior Public Affairs Officer

Regulation

Posted on 15.10.2012

Eucomed: proposed overhaul of EU reg system mostly positive with one caveat

By John Brennan, Director Regulations and Industrial Policy

Regulation

Posted on 18.09.2012

Wedding bells are ringing for the proposal of new IVD regulation

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JesusRuedaRodriguez-web

By Jesús Rueda Rodríguez, Director International Affairs MedTech Europe

Digital Regulation

Posted on 31.08.2012

Policy and regulation for innovation in mHealth

By Jeanine Vos, Executive Director, Mobile Health at GSMA

Regulation

Posted on 25.07.2012

The impact of WEEE2 on the medical devices industry

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By Andy Vaughan, Eucomed Environment Consultant

Regulation

Posted on 09.07.2012

How the approval process of medical devices works in Europe

medical devices regulation

By John Brennan, Director Regulations and Industrial Policy

Regulation

Posted on 02.07.2012

Toward the best possible solution in EU medical device labelling

medical device labelling

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By Merlin Rietschel, Manager Regulatory & Technical Affairs, Eucomed

Access Regulation

Posted on 19.06.2012

Why PMA is a step backwards in the approval approach for medical technology

PMA is a step backward in medical device regulation

By John Brennan, Director Regulations and Industrial Policy