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EU Medical Device Regulation

EU Medical Device Regulation. Cloud Staffing Professionals Is Focused On Helping Medical Device Manufactures Ensure Regulatory Compliance To The EU’s New Medical Device Regulation (MDR). Who are affected?. Notified Bodies Medical Device Manufacturers Authorized Representatives Importers

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EU Medical Device Regulation

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  1. EU Medical Device Regulation

  2. Cloud Staffing Professionals Is Focused On Helping Medical Device Manufactures Ensure Regulatory Compliance To The EU’s New Medical Device Regulation (MDR)

  3. Who are affected? • Notified Bodies • Medical Device Manufacturers • Authorized Representatives • Importers • Distributors

  4. Impact on Product Life Cycle • EU MDR impacts the entirety of the product life cycle process which include: • Design & Development • Regulatory & Quality • Labeling & Packaging • Sterility & Biocompatibility • Medical & Clinical Evidence • Manufacturing & Distribution • Purchasing & Servicing • Post Market Surveillance & Corrective and Preventative Actions

  5. Have you conducted your EU MDR Gap Analysis? Are you aware of: • Changes to your device classification? • Updates to your Clinical Evaluations Reports? • Update to Post Market Surveillance Activities?

  6. Technical Documentation Requirements • Manufacturing Information • Design Information • Design Risk/Benefit Analysis • Production Risk/Benefit Analysis • Clinical Evaluation Report • Sterilization • Biocompatibility • Device Lifetime • Risk Management Report • PMCF Plan and Report • SSCP – Summary of Safety and Clinical Performance • PSUR – Periodic Safety Update Report • PMS Plan • GSPR Checklist • List of Applied Standards • Transport and Packaging • Restricted Substance Justification • Declaration of Conformity

  7. Cloud Staffing Professionals Will Find The Right Personalized Resources Your Company Needs To Ensure Compliance to EU MDR. Call us: 978-712-2220

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