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Medical device product fault reporting the to the US FDA

Medical device product fault reporting the to the US FDA

Do I need to report a medical device product fault to the US FDA? In the unfortunate event that an undetected manufacturing defect is found in a medical device, or there is an error in the use of the product, or other safety problems are encountered during the...

Medical device legacy status: new definition and requirements

Medical device legacy status: new definition and requirements

In March the European Commission reached a decision regarding the MDR/IVDR transition period that has been extend until 31st December, 2027 or 31st December, 2028, as applicable[1]. The MDR/IVDR Amendment, Regulation 2023/607 (Transitional Provisions)[2] was published...

PMS and patient safety: shifting to a proactive approach

PMS and patient safety: shifting to a proactive approach

Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR) implementation being pushed back once more, certain aspects of the MDR that are closely linked to patient safety, such as the need for cyclical and proactive Post Market Surveillance (PMS), are...