EU MDR

You have the road map, we have the playbook. Are you resourced for success?

Providing Guidance and Resources You Can Trust

Compliance Is Within Reach

EU MDR drastically increased the complexity of requirements the medical device industry now faces. Network Partners’ Packaging Engineers and Labeling Specialists identify gaps, develop remediation plans and provide appropriate resources. Regulatory and Project Management resources work to ensure seamless integration and total compliance of these efforts back into your EU MDR program.

Key Changes

MDD v. EU MDR

New EU Medical Device Regulation (EU MDR) differs from the
current Medical Device Directive (MDD) in these key areas:

Changes in Safety and Performance Requirements (GSPRs vs ERs)

     

Technical Documentation

     

Post Market Surveillance (PMS)

     

ISO 11607:2019

     

eIFUs, PILs, Labeling Revisions, and Patient Implant Cards

     

Increased considerations for Clinical Evaluations Reports

     

Important Dates

May 26, 2021

Updated Date of Application (DOA) — MDR Compliance Required for Class I Devices and PMS Requirements in Effect

4-9 Months

Standard Timeline to Total Compliance Complete with Gap Assessments, CER Updates, Verification and Validation

How Network Partners Can Help

Navigating the New Regulations

Take the burden of EU MDR off your to-do list. Our team of Subject Matter Experts execute our proprietary playbook to efficiently bring your medical devices into compliance with EU MDR.

Program Management

Whether you are starting from scratch, have a plan, or are stalled, Network Partners is your one-stop-solution for EU MDR Program Management and compliance.

Regulatory Compliance

Providing you gap assessments on technical documents and clinical evaluation reports and putting a plan in place to remediate and execute.

Packaging Compliance

EU MDR compliance cannot exist without a gap analysis and remediation plan. Network Partners is well versed in planning for execution.

Labeling Compliance

Take the stress of EU MDR off your plate and focus on your product. Network Partners can leverage its team to do the heavy lifting.

Still have EU MDR questions?
Get expert support from Network Partners.

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