If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.
EMA’s IDMP is not the pinnacle of data-based product/regulatory information management. It is simply the first in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. This article reviews best practices for companies looking to maximize the ROI of their data-driven process transformation initiatives by making them more broadly fit for the future.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
In the face of the coronavirus pandemic, the surge in demand for ventilators may push the market to surpass $5.2 billion.
Eighty medtech transactions in Europe came in at a value of approximately $627.5 million.
Whatever the demands of international regulators, it is public expectations that will ultimately dictate the need for life sciences companies to prepare complete and accurate product data that patients and healthcare providers can scrutinize on demand.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.