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.
Certain exemptions apply.
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 that must be provided with the medical device
|Date of commencement||
Different time frames apply to manufacturers and sponsors of urogynaecological and surgical mesh devices.
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.
Manufacturers and sponsors should be mindful of:
- Information Leaflets must not
Manufacturers and sponsors are reminded that Information Leaflets are not intended to be used for promotional purposes.
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.
- 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.
- Listings on the Prosthesis
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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