EU MDR Regulatory Compliance
If European market access for your medical devices is critical to your business, then so is sustained compliance with the EU Medical Device Regulation. QualityHub can build systems and documentation that will meet both European and US FDA expectations.
The implementation date for the European Union (EU) Regulation 2017/745, the EU Medical Device Regulation (EU MDR) is May 26, 2021. Transitioning to the EU MDR is just the first challenge. The next is initial certification to EU MDR by your Notified Body and finally sustaining this certification to ensure uninterrupted access to the EU market.
QualityHub has EU MDR Subject Matter Experts that can help your organization meet these challenges. Contact us to discuss your transition strategy and learn how we can help you meet the challenges of compliance in a complex global regulatory environment.
We can provide assistance in three areas:
Transitioning to EU MDR
• Establishing a Regulatory Compliance Plan for EU MDR Transition
• Gap Assessments of the Quality Management System and Technical Files for EU MDR
• Gap Assessments for Risk Management Programs for EU MDR compliance
• Development of Post Market Surveillance Plans
• Implementing Quality Management System Changes and updates for EU MDR
• Building Technical files for EU MDR
• Preparing for UDI Labeling and Registration
Preparing for Conformity Assessment and Certification by Your Notified Body
• Determination of Device Classification
• Developing a Regulatory Plan for Conformity Assessment
• Selection and Documentation of the Conformity Assessment Pathway
• Pre-Certification EU MDR Audits
• Completing the Declaration of Conformity
Sustaining EU MDR Compliance
• Routine EU MDR Compliance Audits
• Assistance in writing Post Market Clinical Follow-Up Reports (PMCF)
• Development of Post Market Surveillance Reports (PMSR)
• Development of Periodic Safety Update Reports (PSUR)
• Trend Analysis
• Vigilance Reporting
