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.
The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.
When entering this emerging market, the benefits may outweigh any risks.
REACH, which stands for the Regulation, Evaluation, Authorization and Restriction of Chemicals, is a standard that was established by the European Union (EU) in 2007 but does not go into effect until 2018. Simply put, REACH immediately seeks to “limit or prohibit the use of toxic substances in products.” According to an article written by…