Expected changes to medical device regulations have been delayed as a result of the COVID‑19 impacts being faced across the domestic and global medical device industry.
The TGA’s decisions reflect challenges that have been identified by stakeholders, and recognises and mitigates the decision of the European Commission to delay the commencement of most provisions under the European Medical Device Regulations (MDR) by one year, to 26 May 2021.
Amendments to, and implementation of, changes to the Essential Principles in the Australian Medical Device Regulations will be delayed for up to two years following the commencement of European MDR (around May 2023), and the IVD Medical Device Regulations. The IVD MDR is yet to be confirmed by the European Parliament, but is expected to be May 2022 and would therefore impact Australian regulation in 2024.
This delay will provide time for industry to adjust to the EU regulations, to allow consideration of similar changes in the Australian context, and to ensure effective transition implementation within Australia.
AusBiotech responded to the TGA’s consultation Proposed changes to the medical device Essential Principles for safety and performance. It will continue to monitor progress and engage on behalf of members as opportunities arise.
Reclassification of medical devices
The Therapeutic Goods Legislation Amendment (2019 Measure No 1) Regulations 2019, Schedules 1, 2 and 3 that implement changes for a number of devices will be delayed. This includes reclassification, modernisation, clarification, and improving the way custom made devices and software as a medical device are regulated.
This will delay commencement from 25 August 2020 to:
- 25 November 2021 for reclassification of certain devices (allowing commencement to be timed for six months after the changed date for implementation of new EU Medical Device Regulations)
- 25 February 2021 for medical device software, and
- 25 February 2021 for personalised medical devices (including 3D printed devices).
The TGA is preparing regulations to implement the new commencement of these measures in order to be in place before their start date of 25 August 2020.
The kinds of devices to be reclassified include: active implantable medical devices; spinal implantable medical devices (other than spinal fusion implantable devices); medical devices that administer medicines or biologicals by inhalation; active medical devices for therapy that include a diagnostic function to significantly determine patient management; medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system; and medical devices that are substances (or combinations of substances) for introduction into the body through a body orifice, application to the skin or that are absorbed by, or locally dispersed in, the body after introduction or application.
Systems or Procedure Packs
Minor amendments to the requirements for system or procedure packs in Therapeutic goods (Medical Devices) Regulations 2002 will be included. These will reflect the new definition for these products in the Therapeutic Goods Amendment (2020 Measures No.1) Bill 2020 (noting that these will not involve any changes to obligations for sponsors or manufacturers) and will delay the commencement of other changes to the requirements for systems or procedure packs until 25 November 2021.
Guidance, rather than amendments, is being developed on loan kits, responsibility during the packaging process, and the definition of ‘compatability’.