The Medical Devices Introductory Course 2020

“A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.” • All devices must comply with the applicable GSPRs • In MDD these were called “Essential Requirements” – there were 13. • In the MDR they are called GSPRs – there are 23. The 23 are similar to the old 13. • There are some new requirements, e.g. for AIMDs, for devices without an intended medical purpose, for device disposal, for use by lay-persons, etc. General Safety and Performance Requirements Article 5.2 (MDD Article 3)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

27

General Safety and Performance Requirements Annex I (MDD Annex I)

– General requirements – Chemical, physical and biological properties – Infection and microbial contamination – Devices incorporating a medicinal product, materials of biological origin – Construction and environmental properties – Devices with a diagnostic or measuring function – Protection against radiation

– Electronic programmable systems and software – Active devices including active implantable devices – Protection against mechanical and thermal risks – Protection against some other risks – Label and instructions for use including UDI (Article 27)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

28