Even with the extension for legacy medical devices, there’s no time to relax. The EU’s Medical Device Regulation (MDR 2017/745) demands a thorough update of technical documentation to demonstrate full compliance with the new regulatory requirements.
The capacity of Notified Bodies (NBs) remains limited, with more devices competing for conformity assessments. NBs face strict deadlines and narrow error margins, meaning manufacturers are subject to increased scrutiny. They expect complete, well-referenced, and traceable documentation, leaving no room for inconsistencies.
As a manufacturer, missing the mark in this process could mean losing your chance to secure market access. You must provide all requested clinical evidence and manufacturing information in a clear, structured manner to pass this critical assessment.
Ensure Market Access: Achieving CE Mark certification allows your medical devices to be sold across the EU, giving you full access to one of the largest healthcare markets in the world.
Build Trust and Credibility: The CE Mark signifies compliance with stringent safety and performance standards, enhancing your reputation with regulators, healthcare providers, and patients.
Stay Ahead of Competitors: Being CE Mark ready means you can launch or continue selling your products without interruptions, giving you a critical edge in a highly competitive market.
Complete our easy form, and one of our MedTech experts will reach out to discuss your MDR Readiness Checklist and guide you towards CE Mark compliance.
Wherever you are on your QA journey,
we’ve got you covered.
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