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.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
An overview of the key impact points and challenges of European Union Medical Device Regulation.
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.