The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
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.
An overview of the key impact points and challenges of European Union Medical Device Regulation.
The new MDR introduces several changes that manufacturers must consider right away.