The Medical Devices Introductory Course 2020

Obligations of Manufacturers Article 10

• Maintain a system for risk management (Annex I.3) - Thursday • Conduct a clinical evaluation and PMCF (Article 61 and Annex XIV) - Next • Compile technical documentation (Annexes II and III) • Draw up an EU declaration of conformity (Article 19) • Affix the CE mark (Article 20) • Implement and keep up to date a post-market surveillance system (Article 83) - Friday • Record and report incidents and field safety corrective actions (Articles 87 and 88) - Friday • Have a QMS • etc

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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QMS Requirements

• Specified in outline in Article 10.9 and in Annexes IX and XI Part A • Specified in detail in EN ISO 13485: 2016 which is the sector- specific version of ISO 9001 and is a harmonised standard • NB assessment and certification are required for CE marking • Presentation on EN ISO 13485 to follow

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

26