Have your say on proposed refinements to regulation of personalised medical devices

14 June 2021

As a result of strong ADA advocacy, a further consultation paper has been released with proposed refinements to the regulation of personalised medical devices. If actioned, the proposed refinements would result in a significant reduction in the number of devices that would need to be registered and changes to the conformity processes.

We encourage all Members to read the document  and make a submission to the consultation. This would involve answering questions such as:

1. Do you agree with the rationale for the proposed exclusion of products? If not, why not?
2. Do you agree with the rationale for the proposed exemption of Class I nonsterile, non-measuring patient-matched devices when produced under the circumstances listed in this consultation paper? If not, why not?
3. Are there alternative mechanisms for reducing the regulatory burden for patient-matched medical devices without compromising patient health and safety that you would like to propose?