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Medical devices in the EU: a global leader in safety, availability and innovation
Posted on 12.11.2015
Europe is known for providing its citizens with fast access to safe technology thanks to the region’s high innovation competitiveness.
Read moreTowards 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.
Read moreA 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.
Read morePIP: 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.
Read moreMDD 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.
Read moreSafer, 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.
Read moreApproval 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.
Read moreMedical 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.
Read moreSafer, 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”.
Read moreAdvocacy activities related to MD and IVD Regulations
Posted on 03.11.2015
Read moreIn 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.
Read moreThe 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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