Prepare for EU MDR/IVDR Compliance

No longer directives, but laws that enforce penalties, the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) will increase the scope and stringency of compliance dramatically. To minimize exposure, you need an expert partner to ensure your compliance readiness. Why Validant?

eu mdr compliance readiness

Comprehensive Support to Accelerate Compliance Readiness

While the COVID-19 crisis has driven the European Commission to push back the date for MDR to take effect by one year, there are significant changes in clinical evaluation, risk management, general safety and performance requirements (GSPR), supplier/economic operator control, labeling, post-market surveillance, vigilance, and other related processes that manufacturers must address immediately in order to meet even this extended deadline.

Validant employs a proven methodology focused on both rapid execution and empowering your internal quality and regulatory departments to sustain compliant processes. Services include:

  • Gap Assessments: with review of your QMS and technical documentation
  • Notified Body Submissions & Responses: to obtain CE markings and ISO 13845 certificates
  • Compliance Plan Execution: using a phased implementation approach and our boots-on-the-ground experts
  • Training & Knowledge Transfer: to ensure sustainable compliance
  • Ongoing File Maintenance: to help manage new filing complexities
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Work with Proven Experts in EU MDR/IVDR Compliance

Validant’s team has helped multiple medical device clients, from start-ups to top 30 leaders, implement a sustainable approach to EU MDR and IVDR compliance.

Whether you need a turnkey solution to develop and execute
a complete, compliant regulatory strategy or additional
expertise to tackle specific complexities like periodic safety
update reports (PSURs) or clinical evaluation reports (CERs),
Validant will deliver the expert resources you need, when
and where you need them.


Preparing for EU MDR/IVDR Compliance

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