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Article and Insights
Reality Bites as Industry Forces Postponement of MDR Implementation
European Parliament votes to extend MDR transition periods to avoid supply shortages of medical devices while NSAI joins the IVDR club.
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Article and Insights
Regulatory Flexibility – Key Measures to Support Availability of Medicines and Medical Devices During COVID-19
The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted territory. We explore the flexibility of regulators ...
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Article and Insights
Implementation of EU Medical Device Regulation May Face Delay
The European Commission has announced that it is working on a proposal to postpone the date of application of the Medical Device Regulation (MDR) w...
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Article and Insights
What Regulatory Challenges are Facing the Life Sciences Sector?
Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the line with Silicon Republic.
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Article and Insights
Registration Requirements under the Medical Devices Regulation – Where Do We Stand?
In this article, we consider the current status of registration requirements for economic operators and devices under the Medical Devices Regulation.
