Although the first obligation of the Manufacturer stated in Article 10.1 is to design and manufacturer devices in accordance with the Regulation, the Regulation doesn’t contain any dedicated Articles on either Design or Manufacturing.
The reason is that the requirements for design and manufacturing are part of the Quality Management System requirements listed in Article 10, 8. “The quality management system shall address… (g) product realisation, including planning, design, development, production and service provision;”.
Anyone familiar with medical device quality management system requirements will probably recognise Article 10, 8 (g) as both the title and a summary of the contents of Section 7 of the harmonised Standard EN ISO 13485:2016 “Medical Devices - Quality management systems – Requirements for regulatory purposes”.
It naturally follows that the requirement to design and manufacturer devices in accordance with the Regulation means, fulfil the "Product realisation" requirements (Section 7) of EN ISO 13485:2016, which describes the requirements for both Design and development and for Production and service provision in detail.
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