After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.
The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
By simplifying labeling compliance, companies can focus on better serving current and new markets.
This two-part virtual workshop will guide participants through the process of how to write effective documents.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
The Class I recall involves complaints that the connector disconnects from the breathing unit.
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.