Module 17 2024

05/12/2024

Chapter 11: Implantable Devices

o Requiring longer/lifelong patient follow-up for recipients of implants o Considering introducing clearer requirements for seeking informed consent from patients (to the extent this relates to clinical investigations) Implant Cards are to be introduced by the regulations, with the required information defined. Limited exemptions to the requirements for implant information have been included in the regulations. These relate to: o Exempt Implantables: non-resorbable sutures and staples and dental fillings o Exempt Non-Implantables: dental braces, tooth crowns

The Organisation for Professionals in Regulatory Affairs

81

81

Chapter 12: Other Product Specific Changes

Re-manufacturing single-use devices The regulations introduce specific requirements for re-manufacturers of single-use devices The regulations also introduce specific requirements for re-manufacturers of single-use devices on behalf of healthcare institutions (e.g. Hospital SSDs) The regulations will, however, prohibit the re-manufacture of Class I single use medical devices. The government also intends to introduce legislation prohibiting the reprocessing of single-use medical devices. This decision will not impact the reprocessing of multiple-use devices.

The Organisation for Professionals in Regulatory Affairs

82

82

41