Since 1999, the EU and Australia have mutually recognised conformity assessments, certificates and markings. The allows performing conformity assessments for products manufactured in Europe according to Australian regulations and, subsequently, marketing the products within Australia. With effect from January 1, 2013 this agreement has been amended and includes significant changes in the provisions concerning Medical Devices. This means that manufacturers must consider major changes regarding registrations for the Australian market.
On January 1, 1999 the “Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates and Markings between the European Community and Australia” came into effect. One of its sectoral Annexes contains the provisions concerning Medical Devices.
TÜV SÜD Product Service GmbH is designated by its competent authority as a Conformity Assessment Body under the scope of the aforementioned sectoral Annex and is therefore authorised to assess the conformity of products manufactured in Europe with Australian Medical Device Regulations. A certificate that confirms compliance with Australian Medical Device regulations is issued following a positive result of the assessment. This certificate is the manufacturer´s basis for the registration of the device in the Australian Register of Therapeutic Goods (ARTG) without any further need for a complete registration process including review of the technical documentation and audits.
This agreement has been amended and entered into force on January 1, 2013. Herein, the sectoral Annex for Medical Devices has been completely replaced. This may cause considerable impact on manufacturers’ registration planning for the Australian market.
Conformity assessment certificates issued under the current MRA for Medical Devices – that will become excluded from the scope of the MRA by the Amending Agreement – will continue to be valid after the Amending Agreement comes into force until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.
Conformity Assessment Bodies that are designated under the current MRA to issue certificates for Medical Devices – that will become excluded from the scope of the MRA by the Amending Agreement – will be considered to be designated under the Amending Agreement for the purpose of maintaining such certificates until the certificate expiry date or five years from the date that the Amending Agreement comes into effect, whichever is earlier.
Any new conformity assessment certificates issued under the MRA once the Amending Agreement comes into effect must be issued according to the provisions of the new Amended Agreement.
The main changes
The Amendment contains the following significant changes:
A "rule of origin" clause (which stipulates that only those products manufactured in the European Union or Australia are covered by the MRA) has been removed from the overarching MRA and replaced with a more specific clause in the Medical Devices Sectoral Annex. Activities such as repairing, reconditioning, refurbishment, labelling, packaging, quality control inspections alone, or sterilisation alone, will be specifically excluded from the definition of "manufacture".
Extension of scope – radioactive Medical Devices of lower risk classes will be included in the MRA.
Temporary exclusion – the Amending Agreement expands the range of high risk Medical Devices that will no longer be able to be assessed under the MRA, until confidence building activities have been undertaken by Australia and the European Union. These are:
active implantable devices as defined in the legislation referred to in Section I;
devices that are classified as class III devices under the legislation referred to in Section I;
Medical Devices that are implantable intra-ocular lenses;
Medical Devices that are intra-ocular visco-elastic fluids, and
Medical Devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.
Following combination products are completely excluded from the scope:
Medical Devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;
Medical Devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;
Medical Devices incorporating tissues or tissue derivatives of human origin;
Medical Devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;
Medical Devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and
Medical Devices that are intended by the manufacturer specifically to be used for chemical disinfection of other Medical Devices, except for sterilisers using dry heat, moist heat or ethylene oxide.