Module 17 2024

05/12/2024

Chapter 12: Other Product Specific Changes

The regulations will also introduce more stringent requirements for the post market surveillance of custom-made devices. This includes the requirement for periodic summary update reports for Class IIa, IIb and III custom-made devices or post-market surveillance reports for Class I custom-made devices. The regulations will require manufacturers of Class II and Class IIb custom made devices to implement a Quality Management System, which must be certified by an Approved Body. Class I and Class IIa custom-made devices will also require an appropriate QMS in place, but the QMS will not require Approved Body certification. The regulations will also clarify that an electronic prescription can be written by a medical practitioner who prescribes specific characteristics for the design of the custom-made medical device.

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eIFU’s The existing UK regulations currently allow that, for certain medical devices and in certain circumstances, electronic instructions for use (e-IFUs) can be used rather than printed versions. The relevant device must be intended to be used by healthcare professionals, have an adequate risk assessment conducted for electronic format, be available in a paper copy if requested, and have the same content as the paper version would. (EU Directives 207/2021 & 2021/2226) The new regulation will extend this provision to software and apps supplied directly to end users and healthcare professionals. No further extensions are included at this point, but this will be kept under review. Chapter 13 - Environmental Sustainability and Public Health Impacts

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