The Therapeutic Goods (Medical Devices) Regulations 2002 as amended applies to medical devices and IVDs in Australia.

The Therapeutic Goods Administration (TGA), a Division of the Commonwealth Department of Health and Aged Care, is responsible for administering the legislation. The Medical Devices and Product Quality Division within the TGA is responsible for regulating IVDs and medical devices.

• A risk based classification scheme using Class I, Class IIa, Class IIb, and Class III for medical devices, and Class 1, Class 2, Class 3, and Class 4 for IVDs.
• Essential Principles for the quality, safety and performance of the medical device and IVDs that must be complied with before the product can be supplied.
• Options as to how to demonstrate compliance with the requirements.
• The use of recognised standards to meet requirements of the Essential Principles.
• A post market surveillance and adverse incident report system.
• Regulatory controls for the manufacturing processes of medical devices and IVDs, including Quality Management System requirements.
• The Australian Register of Therapeutic Goods (ARTG).

Classification is based on the manufacturer’s intended use, level of risk, period of use, and degree of invasiveness to the human body.

Correct classification is the responsibility of the manufacturer; KD&A can support with a Medical Device Classification Assessment.

This is a checklist that provides details on:

• General requirements: Major safety and performance requirements that apply to all medical devices and IVDs.
• Particular requirements: These only apply to certain medical devices and IVDs.
• Information to be provided with the medical device or IVDs (instructions for use, labels).
• Clinical evidence

Clinical evidence is clinical data derived from a clinical investigation, clinical investigation program or literature. A critical evaluation, which is a critical appraisal of the medical device and clinical data, is also necessary. The critical evaluation must be completed by a competent clinical expert in a relevant field.

The TGA can issue CE Marking (utilising the Mutual Recognition Agreement (MRA)) to Australian medical device manufacturers.

Note; the TGA was previously able to issue CE Marking under the Medical Device Directive (MDD) 93/45/EEC due to the established Mutual Recognition Agreement (MRA) with EU. The TGA could provide CE Marking under MDD 93/42/EEC as an additional service when completing a conformity assessment process for an Australian medical device manufacturer until 25^th May 2020.

The TGA is currently under negotiation with the European Commission to amend the MRA to issue CE Marking certification under the Medical Device Regulations (MDR) (EU) 2017/745. No official communication has been provided by the TGA regarding how and/or when the amendment will be done/completed. It is not possible to predict how long the amendment and/or re-negotiation of a new agreement will take. Therefore, CE Marking certification via TGA (as an additional service when completed the conformity assessment process) is not a feasible option at present.

Yes, it is possible to gain Australian certification as a sponsor. To complete this process, product certifications such as CE Marking, MDSAP, 510(k) clearance, Health Canada certifications, etc. must be available and maintained by the manufacturer.

KD&A can assist with this process.

CE Marking is affixed to products that meet the safety standards that apply to all countries of the European Union (EU). Products that have CE Marking can be placed on the market within the EU.

To be able to add this mark to their products, manufacturers must follow a set of procedures outlined in the relevant Directive or Regulation for their product. Each Directive or Regulation covers a range of products and specifies the essential safety requirements that products must satisfy before they may be sold anywhere in the EU.

CE Marking is required on designated products exported to the European Union (EU).

The 27 EU member states are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

The Medical Device Regulation (MDR) (EU) 2017/745 is the European Union legislation that regulates medical devices.

MDR (EU) 2017/745 regulates medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

The date of application for the MDR (EU) 2017/745 was 26 May 2021.

The In-vitro Diagnostics Regulation (IVDR) (EU) 2017/746 is the European Union legislation that regulates in-vitro diagnostic medical devices.

IVDR (EU) 2017/746 regulates in-vitro diagnostic medical devices repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

The date of application for the IVDR (EU) 2017/746 was 26 May 2022.

The classification information contained in the medical device applicable regulation or directive provides details on the class level of each product and establishes the necessary requirements to enable CE Marking of the product/s.

Correct classification is critical. Certain classifications require technical documentation, implementation and maintenance of a Quality Management System based on ISO 13485 and Notified Body assessment, to enable CE Marking certification. Lower classifications only require technical documentation to enable CE Marking certification.

One of the most important aspects of obtaining CE Marking is the compilation of technical documentation.

The CE Mark must be affixed to the product, or if this is not possible, to its packaging. It must also be affixed to the accompanying documents by the manufacturer, or the authorised representative in the European Union (EU). The CE Mark must have a height of at least 5.0mm.

Products which do not have CE Marking and are not compliant with the MDD/MDR may be restricted, prohibited from sale, or forced to withdraw from the European market.

Manufacturers and authorised representatives, or anyone responsible for placing products on the European Union (EU) market without complying with the appropriate EN standards, can be held personally liable for damages or injury, as well as being prosecuted.

A Notified Body holds the authority to assess and complete CE Marking applications. They must be totally independent from the manufacturer. Notified Bodies perform unbiased testing and assessment tasks and certify that the manufacturer has taken steps to ensure compliance, they do not approve a product to be safe. Manufacturers and exporters may choose a notified body located in any EU member state. KD&A can recommend a Notified Body for your company.

Prices vary between Notified Bodies, product type and conformity assessment procedures. It is recommended that you obtain quotes from several notified bodies. Ensure that quotes determine the costs for ongoing certification and additional markets. For example; Canada, Asia, and New Zealand.