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).
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.
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
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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
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
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.
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
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
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
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