The Medical Devices Introductory Course 2020

Post Market Surveillance

2017/745 Article 83 “Post-market surveillance system of the manufacturer” Sets out the requirements for the PMS system including the specific purposes for which the data shall be used

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2017/745 Article 84 “Post-market surveillance plan” Establishes the requirement for a documented PMS plan, to be included in the technical documentation. Introduces Annex III.

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The Organisation for Professionals in Regulatory Affairs

Post Market Surveillance

2017/745 Article 85 “Post-market surveillance report” Establishes requirement for a PMSR, to be maintained on file and made available upon request (for class I devices)

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2017/745 Article 86 “Periodic safety update report” Establishes the requirements for a PSUR, to be updated at least annually (for class IIb and III) and at least every 2 years (for class IIa) and submitted as part of the technical documentation PSUR’ s for class III and implantable devices to be uploaded to EUDAMED (May 2022) and sent to the NB

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The Organisation for Professionals in Regulatory Affairs