The Certification Process in Europe relies on a decentralized model: Notified Body.
These independent organizations are designated to assess the conformity of Medical Devices with the EU Medical Device Regulation (MDR) or In-Vitro Diagnostic Regulation (IVDR).
Their key responsibilities include:
✔️ Reviewing Technical Documentation: the foundation of every conformity assessment.
✔️ Auditing Quality Management Systems (QMS): ISO 13485 is not legally required, but provides a globally recognized framework and is strongly recommended.
✔️ CE Certification of higher-risk devices: mandatoty for Medical Device Class IIa, IIb, III and IVD Class B, C, D.
✔️ Ensuring compliance: verifying QMS effectiveness through external audits.
WQS will guide you through the entire process and coordinate with Notified Bodies to ensure a smooth certification process.
Get more informationen: CE Certification for Medical Devices.
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