News in Brief

Updated lists of harmonised standards for medical devices and in-vitro diagnostic (IVD)

The European Commission has published updated lists of harmonised standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).

Posted on 27. Februar 2018

Will EU Common Specifications interfere with International Standardisation?

Common Specifications already exist in the EU’S IVD Directive but using them to cover medical devices too is causing concern about how they might have an effect not only EU standards, but more importantly on international standards agreements.

Posted on 23. Februar 2018

Could manufacturers using UK notified bodies have post-Brexit difficulties?

There is some apprehension among manufacturers who have used one of the UK’s notified bodies to appraise the conformity of their medtech products against the medical device directives about the effects of Brexit on their products’ continued existence on the … Continue reading

Posted on 20. Februar 2018

mdi Europa Customer Survey 2017

Short summary of results

Posted on 17. Februar 2018

It is often unclear as to when a notified body needs to be informed when updating your device in the EU

Innovation in the medical devices sector is as much linked to incremental changes in product design as it is to revolutionary new technologies. But when does a change to a previously marketed product, also known as a line extension, need … Continue reading

Posted on 3. November 2017

Change to definitions and scope: Incident Reporting in Germany

Currently, the national transpositions of the MDD are still valid. The German transposition of MDD is MPG. In addition, the so-called MPSV describes how incidents or possible incidents have to be reported and – more importantly, how Germany defines what … Continue reading

Posted on 2. November 2017

TÜV SÜD delays compliance deadlines for state-of-the-art requirements of MEDDEV 2.7/ Rev.4

Major European Notified Body TUV SUD has extended its implementation timeline for medical device state-of-the-art clinical evaluation requirements under MEDDEV 2.7/1 Rev.4 to make more time available for manufacturers to ensure compliance.

Posted on 29. Oktober 2017

Reusable devices: how efficient is your cleaning validation?

Creating a cleaning validation for a reusable medical device poses several challenges. Many problems have occurred over the last seven years causing greater scrutiny of cleaning validations. FDA published the 2015 guidance ‘Reprocessing Medical Devices in Health Care Settings: Validation … Continue reading

Posted on 28. Oktober 2017

Is there a risk in revising the risk management standard, ISO 14971, for medical devices?

Risk management is an important process for the medical devices sector. Inserting detailed regulatory requirements into a forceful risk management process can result in more successful compliance with user needs and legal responsibilities. The International Standard ISO 14971:2007-Medical devices-Application of … Continue reading

Posted on 25. Oktober 2017

It is important not to confuse ‘intended use’ with ‘indications for use’

In the medical device industry the two terms ‘intended use’ and ‘indications for use’ are often considered as interchangeable. It is important not to confuse the two terms and put the timelines of a product release and regulatory compliance in … Continue reading

Posted on 23. Oktober 2017
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