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Patient safety

Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe

Posted on 11.11.2015

The revision of the EU Medical Devices Directives has entered a critical phase. The European Parliament has finalised its report and must now work together with the EU Council towards agreement on a final text.

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New medtech regulations

A clear, predictable and effective regulatory framework for Europe

Posted on 10.11.2015

Eucomed recognises the need to modernise and strengthen the current medical devices legislation in Europe, in particular, by strengthening the decentralised Notified Body system and increasing EU Member State co-ordination.

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Patient safety

PIP: Never again

Posted on 09.11.2015

As was widely reported in early 2012, the firm Poly Implant Prothèse (PIP) allegedly violated regulations by using unapproved industrial-grade silicone in some of its implantable products and by allegedly falsifying or withholding documents. Allegations, which if confirmed, can only be strongly condemned as disgraceful behaviour and an egregious breach of trust.

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New medtech regulations

MDD Fact sheets

Posted on 08.11.2015

The scope of any legislative measure must be as clear as possible to avoid potential confusion and fragmentation in its implementation.

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Patient safety

Safer, timely and life-changing: medtech innovation is good for patients and policymakers alike

Posted on 06.11.2015

The key to success in the medical technology industry has been continuous innovation and a dedication to research and development.

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Patient safety

Approval system: bringing new technology to market

Posted on 05.11.2015

The recent PIP breast implant incident has made it crystal clear that healthcare actors must pull together to ensure that such a case of fraud never happens again.

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Patient safety

Medical devices and pharmaceuticals: Two different worlds in one health setting

Posted on 04.11.2015

While the medical technology and pharmaceutical industries are both essential to health, it is important to acknowledge that the two are extremely different.

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Patient safety

Safer, healthier patients with the fastest access to the latest life-saving technology

Posted on 03.11.2015

The European Union defines patient safety as: “Freedom for a patient from unnecessary harm or potential harm associated with healthcare”.

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New medtech regulations

Advocacy activities related to MD and IVD Regulations

Posted on 03.11.2015

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New medtech regulations

In Vitro Diagnostic Medical Devices Directive

Posted on 07.09.2015

The safety and performance of in vitro diagnostic devices are regulated in the EU by the 1998 In Vitro Diagnostic Medical Devices Directive (IVDD). This sets a framework for manufacturers and for authorised representatives who seek to place IVD products on EU market. It aims to ensure that IVD devices comply with stringent standards for quality and safety, and produce reliable data to be used for diagnostic purposes.

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The environmental impact of medtech

Posted on 04.09.2015

All industries leave an environmental footprint. The European medical technology sector is committed to being as low-impact and green as possible, an approach that complements its efforts to improve the health and welfare of citizens. The medtech industry recognises its duty to act responsibly and work in a sustainable way. MedTech Europe gives feedback to environmental regulators while also providing information on compliance with regulations.

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Transparent and ethical relationships

Posted on 31.08.2015

The very nature of the medtech industry implies a close relationship with physicians, nurses, lab technicians and other healthcare professionals (HCPs). Interactions with HCPs and healthcare organisations (HCOs), such as hospitals and clinics, are a key part of the day-to-day activities of medtech companies.

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