in compiling the clinical evidence for a supportive device the sponsor should ensure that a clinician who is an expert in the field and experienced in the use of the device compiles and critiques all the clinical data that informs on the safety and performance of the device the clinical expert must review and endorse the CER containing the clinical evidence to demonstrate that the evidence the requirements of the applicable EPs and the device is safe and performs as intended. Defining joint prostheses This guidance document describes joint prostheses as an implantable medical device, irrespective of its configuration, that is intended by the manufacturer to replace in full or in part a section of the joint. From the MD Regulations— joint replacement medical device means an implantable medical device: that is intended by the manufacturer to operate (either or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and that (either or together with one or more other implantable medical devices): replaces or substitutes for the articulating surface of a shoulder hip joint or knee joint (in whole or in part); or provides primary fixation to the bone for the replacement articulating surface; or connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic element of the joint replacement; but does not include an ancillary medical device. ancillary medical device means an implantable medical device that: consists of screws, plates or wedges; or is intended by the manufacturer to be used to: provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint; or provide bone substitution in relation to, or additional fixation for, any such device; or otherwise assist any such device; where the individual requirements of a patient make it appropriate to do so. Joint prostheses can consist of either a monoblock or modular design. There are practical advantages to modular designs as they allow tailoring of the prosthesis to the patient’s anatomy. However, modular devices with multiple components are more complex and may have a
in compiling the clinical evidence for a supportive device the sponsor should ensure that a clinician who is an expert in the field and experienced in the use of the device compiles and critiques all the clinical data that informs on the safety and performance of the device the clinical expert must review and endorse the CER containing the clinical evidence to demonstrate that the evidence the requirements of the applicable EPs and the device is safe and performs as intended. Defining joint prostheses This guidance document describes joint prostheses as an implantable medical device, irrespective of its configuration, that is intended by the manufacturer to replace in full or in part a section of the joint. From the MD Regulations— joint replacement medical device means an implantable medical device: that is intended by the manufacturer to operate (either or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and that (either or together with one or more other implantable medical devices): replaces or substitutes for the articulating surface of a shoulder hip joint or knee joint (in whole or in part); or provides primary fixation to the bone for the replacement articulating surface; or connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic element of the joint replacement; but does not include an ancillary medical device. ancillary medical device means an implantable medical device that: consists of screws, plates or wedges; or is intended by the manufacturer to be used to: provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint; or provide bone substitution in relation to, or additional fixation for, any such device; or otherwise assist any such device; where the individual requirements of a patient make it appropriate to do so. Joint prostheses can consist of either a monoblock or modular design. There are practical advantages to modular designs as they allow tailoring of the prosthesis to the patient’s anatomy. However, modular devices with multiple components are more complex and may have a
consult-draft-clinical-evidence-guidelines-medical-devices.docx