Nov 2018 JDSupra

In October 2017, a new regulatory regime consistent with the EU Medical Devices Regulation (MDR 2017/745) was introduced for implantable and active implantable devices supplied in Australia. Manufacturers are reminded that the requirements for patient implant cards (Implant Cards) and patient information leaflets (Information Leaflets) are to be phased in from 1 December 2018.

What devices are captured?

Consistent with the MDR 2017/745, the types of devices captured under the new changes include any device, including those that are partially or wholly absorbed, which is intended:

  • to be totally introduced into the human body, or
  • to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intend to remain in place after the procedure.  

This includes, for example, pacemakers, neurostimulators, cochlear implants and hip, shoulder or knee replacement devices.

Checklist requirements

A summary of the requirements are as follows:

 

Information Leaflets

Implant Cards

Description

A leaflet or brochure containing important information to patients about the medical device to facilitate discussion and assist with the decision-making process.

Small, portable card intended to be provided to patients after surgery.

Mandatory requirements

Information that must be provided with the medical device include, amongst others:

  • information identifying the device, or the kind of device such as the name and model of the device
  • intended purpose of the device
  • information explaining how to use the device safely
  • nature and frequency of regular or preventative examination, monitoring or maintenance of the device
  • notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA

Information that must be provided with the medical device include the:

  • name of the device
  • model of the device
  • batch code, lot number or serial number of the device
  • unique device identifier of the device (if any)
  • manufacturer’s name, address and website address

Date of commencement

  • New devices:
  • 1 December 2018
  • Existing devices:
  • 1 December 2021
  • New devices:
  • 1 December 2020
  • Existing devices:
  • 1 December 2021

 

Impact
The introduction of the requirement to have Information Leaflets and Implant Cards has placed a heavier burden on manufacturers and sponsors.  The challenge for manufacturers of new devices is that certain types of data may not be readily available from the outset. For example, it may be difficult to clearly particularise precautions and other measures that should be taken at, or near, the end of the expected device lifetime. However, in order to demonstrate compliance with the Essential Principles, this information may now be required.  Manufacturers also have an obligation to notify the TGA of any substantial changes to a device.

Key considerations
Manufacturers and sponsors should be mindful of:

  1. Information Leaflets must not be promotional Manufacturers and sponsors are reminded that Information Leaflets are not intended to be used for promotional purposes.
  2. The definition of ‘advertise’ under the Therapeutic Goods Act 1989 (Cth) is broad and intended to maintain a wide compass. Areas of risk include inadvertent promotion.For example, an Information Leaflet published on a sponsor’s website along with promotional content may be deemed to be an advertisement. In such case, compliance with the Therapeutic Goods Advertising Code (TGAC) and therapeutic goods legislation are necessary.
  3. Electronic leaflets Manufacturers and sponsors opting to have electronic leaflets should ensure:
    • patients are able to easily access and identify their correct leaflet on the manufacturer’s website; and
    • Information Leaflets published on a manufacturer’s website are compliant with the TGAC and therapeutic goods legislation.
  1. Listings on the Prosthesis List As part of the reforms, certain medical devices such as surgical mesh devices have been up-classified. Suppliers of affected devices which have been reclassified will need to update their Prostheses List listings in order to remain on the Prosthesis List and to ensure benefits continue to be paid by private health insurers

 

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