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      Medical Devices

    Article 117 Documentation Submission Best Practice Guidelines

    This technical documentation submission guidance is aligned to the requirements of (EU) 2017/745 Medical Devices Regulation (MDR) Annex I.

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    Preparing Article 117 documentation

    This document draws on BSI¡¯s extensive experience in the conduct of Article 117 and covers:

    • Submission and Technical Documentation contents.

    • Submission method.

    • Document format.

    • Additional topics to consider when preparing Technical Documentation for submission.

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