KEY CHANGES
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1. Designating a Notified Body
- All Notified bodies shall be re-designated according to the MDR and shall comply with the requirements set forth in Annex 7 of the new MDR.
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2. Identifying Authorized Representatives and Compliance personnel
- In order to obtain CE mark for medical devices, it is necessary to appoint a legally qualified and authorized representative for compliance with the EU's medical device regulatory requirements
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3. Product Classification
- The medical device grade should be reclassified according to risk, contact time, and invasive nature, and the technical documents should be updated.
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4. Clinical Data
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The clinical evaluation report (CER) should be kept as sufficient clinical evidence for safety and performance of medical devices.
The PMCF should also be carried out as part of an ongoing assessment of residual risks. -
5. Vigilance System and PMS (Post-market surveillance)
- Data including medical device information, certification authority information, certificates, Safety and Clinical Performance Reports (SSCPs), Periodic Safety Update Reports (PSURs), PMCF reports, and Clinical Evaluation Reports should be uploaded to EUDAMED. In addition, for Class III and Class IIb devices, the PMCF reports and PSUR reports must be updated annually.
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6. Unique device identification (UDI) requirements
- The UDI system is introduced to provide traceability of medical devices. Device identifiers and production identifiers, which should include information about manufacturers and their authorized representatives and importers.
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7. ISO 13485:2016
- Upgrading to version ISO 13485:2016, the existing ISO 13485:2003 certificate will be invalidated
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