The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
MedTech Intelligence readers continue to crave information about the new regulation.
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.