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The Medical Devices Unit of the South African Health Products Regulatory Agency (SAHPRA) regulates the licencing of medical device...
Susanna Al Halabi
Regulatory Lead , Intertek
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Digital transformation has swept through all aspects of the world over the past few decades, connecting many devices and systems. While...
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In our MDR article series, we’ve briefly touched on the concept of a grace period. This is a transition period of three years for...
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The 26 May 2024 deadline for Medical Device Regulation (MDR) is approaching fast, yet, for many medical device manufacturers there is...
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The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a notable change in the EU (European...
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Intertek Medical Notified Body UK Ltd (IMNB UK) is very pleased to announce we are now UKAS accredited for ISO 13485. The scope of our...
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation...
The extension of the MDR transitional period and the deletion of the MDR/IVDR 'sell-off' dates has entered into force. Regulation (EU)...