EU MDR Checklist

Use the EU MDR Checklist to navigate medical device regulation compliance, ensure adherence, track progress, document and address regulatory requirements.

EU MDR Checklist



Scope, Classification, And Routes Of Conformity

1. Have you identified the impact of the new MDR classification on the conformity assessment that should be carried out for each device in your scope?


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Transitional Provisions

1. Is post-market surveillance implemented?


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2. Is market surveillance implemented?


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3. Is vigilance implemented?


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4. Is the registration of economic operators implemented?


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General Requirements

1. Is there a system implemented to identify new devices added to the scope or reclassified devices according to the classification routes?


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2. Based on the classifications, is an appropriate conformity assessment procedure (MDR Article 52) identified and followed?


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3. Is a single registration number (SRN – Article 31) created?


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4. Is an economic operator (Article 30) registered?


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5. Have you considered the increased obligations and agreements with importers and distributors (Articles 13, 14, and 16)?


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6. Is a person responsible for regulatory compliance (Article 15) nominated?


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7. Have you worked on an agreement with an EU-authorized representative (Article 11)?


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8. Is there a set strategy for regulatory compliance, unique device identification and registration, and handling communication with authorities, notified bodies, and economic operators?


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9. Have you defined a process for producing, monitoring, and controlling the UDI system (UDI-DIs and UDI-PIs) and how to place it on the device (Article 27-29)?


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10. Is the declaration of conformity updated?


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11. Has the impact of MDR on the labeling and new requirements, such as the implant card (Article 18) been assessed?


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General Safety And Performance Requirements

1. Are the MDD essential requirements replaced by the general safety and performance requirements?


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2. Have you ensured compliance with all the new GSPRs?


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Technical Documentation

1. Is the technical documentation in English, organized, readily searchable, and in an unambiguous manner?


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2. Is the technical documentation by Annex II and III of MDR updated?


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3. Have you considered the life-cycle approach?


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4. Are the new requirements included, such as UDI, state-of-the-art, clinical evaluation requirements, a summary of safety and clinical performance, periodic safety update report, and new Italian nomenclature for each of the technical documents?


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5. Have you considered the summary of safety and clinical performance (Article 32), if applicable?


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Post-Market

1. Are procedures for an adequate pro-active gathering of data, before applying for MDR certification implemented?


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2. Are procedures for the PMS Plan – Article 84 implemented?


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3. Are procedures for the PMS Report – Article 85 implemented?


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4. Are procedures for Periodic Safety Update Reports – Article 86 implemented?


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5. Are procedures implemented for reporting serious incidents and field safety corrective action – Article 87?


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Clinical Evaluation

1. Is there sufficient clinical evidence for the device gathered?


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2. For all Class III implantable devices and Class IIb active devices that administer or remove a medicinal product, have you considered whether your device will need or can be exempt from clinical evaluation consultation procedure (Article 54)?


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3. Have you managed to comply with MDR’s new equivalence route requirement, and evaluated the necessity of clinical investigation or justification if not relevant?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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