Module 17 2024

05/12/2024

Chapter 12: Other Product Specific Changes

Systems, kits and procedure packs The regulations will clarify that a ‘kit’ should be regulated in the same way as a system or a procedure pack. This would help avoid confusion regarding the regulation of combinations of products (which include IVDs, general medical devices and other products) used for in vitro diagnostic examination. The definitions of systems, procedure packs and kits will also allow external software (for example, a specific app identified in the labelling) to be considered as a component of the system, procedure pack or kit. The regulations will introduce additional requirements for assemblers of systems, kits and procedure packs The Regulations also require that these procedures be outlined in the assembler statement/declaration. Finally, the assembler will require that an appropriate QMS be put in place.

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Chapter 12: Other Product Specific Changes

Parts and components The regulations will require any individual or company who supplies an item specifically intended to replace an identical or similar integral part or component of a medical device that is defective or worn to ensure that the item does not negatively affect the safety and performance of the medical device. Additionally, any components which make a significant change to the safety and performance of a medical device are to be regulated as medical devices in their own right. Custom-made devices The regulations will introduce more detailed requirements for the technical documentation that must be drawn up and kept by the manufacturer of a custom-made device. Manufacturers will be required to draw up a clinical evaluation report and keep information on how the relevant essential requirements of the Regulations were identified and actions taken to ensure the requirements have been met.

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