Module 17 2024

05/12/2024

Chapter 11: Implantable Devices

The original consultation document proposed the expand the scope of implantable devices to include temporarily implanted devices. However, the decision has been made that no changes to the scope will be made as either the proposed devices are already in the scope of the regulations (dermal fillers, breast implants) or there is no strong rationale for amending the scope to include them. There was also discussion on excluding ophthalmic visco surgical devices (OVDs) from the scope of regulated implantable medical devices, but this was also rejected. Similarly , there was discussion on increasing pre-market requirements for implantable devices; again, this proposal has not been accepted. Therefore, further proposed implantable-specific requirements in the technical documentation and clinical evidence requirements will not be implemented.

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Chapter 11: Implantable Devices

Conversely, no exemptions to clinical evidence requirements for specific implanted devices such as screws and wedges are to be included in the regulations. This differs from the approach taken elsewhere, for example, in the EU & US. The original consultation proposals also included introducing more controls over access to high-risk implantable devices, such as restricting sales to only to medical device users in centres specialising in their use. Again, none of these proposals have been accepted. However, the following proposals have been accepted: o Measures to improve implant traceability, including through the introduction of requirements for implant information. o Reducing the ability for manufacturers to rely on equivalence to a predicate device as part of the pre-market approval process for implantable medical devices

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