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.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
A look at the practical implications of the regulations, the market opportunity and tips for compliance.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
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.