The EU MDR has significantly altered the way the healthcare and medical equipment sectors operate in Europe. Compliance standards for medical devices in terms of safety, transparency, and traceability have grown more complex as the earlier Medical Device Directive (MDD) has been substituted by the MDR. For healthcare niches, especially if your speciality includes the production, distribution, or usage of medical devices in the EU, adherence to the MDR compliance is now a regulatory requirement.
This detailed guide explains the fundamental EU MDR Compliance Services for healthcare companies, describes who the regulation pertains to, and gives a useful roadmap for how to prepare for MDR audits. If you work in healthcare or are a healthcare service user, this is a great starting place.
*EU MDR Compliance Checklist for Healthcare Companies
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Here’s an actionable EU MDR compliance checklist to ensure your compliance efforts:
- Correctly classify each medical device
- Prepare/Revise technical documents according to MDR
- Perform or renew clinical evaluations
- Register devices and economic operators in EUDAMED
- Establish a UDI system
- Create a PMS plan and PSUR reporting
- Update your QMS to MDR standards
- Update product labeling and IFU
- Provide training on MDR changes
- Implement an internal audit and compliance review process
You might like to explore the Compliance security audit service.
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