Clinical Evaluation EU-MDR requirements
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Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements  This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745].  What is meant by the term ‘clinical evaluation’ in the EU MDR?  The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned…

ISO 22442 – Medical Devices containing animal materials
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ISO 22442 – Medical Devices containing animal materials

Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…

Unique Device Identification (UDI) system for medical devices in Australia
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Unique Device Identification (UDI) system for medical devices in Australia

What is a Unique Device Identifier (UDI)? Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to: The Unique Device Identifier of a medical device typically includes two parts: History of UDI The first concept of UDI was signed into US law and added as part…

Brexit and Medical Devices Regulation in the United Kingdom
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Brexit and Medical Devices Regulation in the United Kingdom

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union. What does this mean for Australian based medical device manufacturers wishing to place their device on the UK…

Custom-Made Medical Devices | Changes – February 25, 2021

Custom-Made Medical Devices | Changes – February 25, 2021

Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf devices that are customised, adapted or modified after supply, also known as adaptable medical devices. Custom-made…