Proposed refinements to the requirements for medical device patient information materials

Closed 1 Sep 2021

Opened 17 Aug 2021

Overview

It is important that patients have access to information about their implanted medical devices.

Globally, the requirements for medical device patient information materials vary. Implementation of requirements for these materials in Europe is occurring now through to 2024, whilst in USA and Canada there are requirements already in force.

In Australia, in late 2017, the Government approved regulations that require patient information materials to be supplied with implantable and active implantable medical devices.  In 2018, following consultation with health professionals, consumer groups, consumers and the medical device industry, guidance was published on the TGA website setting out detailed requirements for patient information materials.

In 2020, revised guidance was published Guidance document for PICs and PILs, taking into account lessons learnt from two years of implementation, as well as consumer and sponsor feedback to include:

  • further clarification on the content and form of patient information leaflets (PIL) and patient implant cards (PIC);
  • devices that are exempt from the requirements to provide PIC and PIL;
  • specific information about urogynaecological meshes and breast implants.

 

 

 

Why your views matter

Feedback received from consumers, health care professionals, surgeons, hospitals and medical device companies has identified some impracticalities and challenges for how patient information materials are provided to patients.

We are consulting to seek views on potential refinements to how and when patient materials should be available and when they may not need to be provided with certain devices.

What happens next

Your input and feedback will help inform any changes to the Regulations in relation to patient information materials.

 

Audiences

  • Anyone from any background

Interests

  • Hospitals
  • Legislation
  • Regulatory policy