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.
The new MDR introduces several changes that manufacturers must consider right away.
UK and European manufacturers should put a UDI implementation plan in place ASAP.