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What is Conformity Assessment of a Medical Device?

25 February 2011

Following is another contribution to our series of posts explaining the processes involved in taking a medical device to market. This one focuses on the strict regulations and rigorous steps set out by the therapeutic goods legislation to ensure devices meet all regulatory requirements before reaching consumers.

Key to all of this is the conformity assessment of a medical device, conducted to provide objective evidence of the safety, performance, benefits and risks of a specific device whilst also providing regulatory bodies with peace of mind that regulatory requirements have been met.

During the conformity assessment the manufacturer must demonstrate that both the device and the processes used to make the device conform to the Essential Principles.

What are the Essential Principles?

The Essential Principles ‘set out the requirements relating to the safety and performance characteristics of medical devices’, for example the device must be suitable for the manufacturer’s intended purpose.

According to the Therapeutic Goods Administration (TGA), “Manufacturers can demonstrate that the Essential Principles have been met for a device in many ways. Some examples include:

  • a documented and detailed risk analysis
  • the results of testing of the medical device
  • literature searches
  • copies of the label, packaging and Instructions for Use to demonstrate that information requirements have been met
  • expert opinion
  • the design dossier, if applicable”

The Essential Principles can be found in detail at the end of this posting*.

Are all assessments the same?

The assessment of the medical device varies depending on the type. The TGA uses a ‘risk management’ model, which means the level of scrutiny during assessment increases with the following risk classifications of the device:

I Low risk
IIa Low-medium risk
IIb Medium-high risk
III High risk

An active implantable medical device (such as a pacemaker) for example is considered high risk and is therefore subjected to the highest level of scrutiny.

What if the device has already met assessments internationally?

Australia is also a founding member of the Global Harmonisation Task Force (GHTF) which aims to harmonise medical device regulatory systems among the five member markets: Australia, European Union, United States, Canada and Japan.

As such the TGA has a mutual recognition agreement with the European Union.  This means that Conformity Assessments issued by the TGA are recognised in Europe, and the equivalent assessments conducted by Notified Bodies in Europe (known as CE Mark) are recognised by the TGA.

Developing markets such as South America are also in the process of looking at adopting the GHTF principles.

What are the benefits of the Global Harmonisation Task Force?

The benefit is that Australian medical device manufacturers only have to complete the one assessment, which is more cost effective and saves time, meaning that devices make it onto the market without unnecessary regulatory hold ups.

*Essential Principles

As per the Therapeutic Goods Act 1989, there are six Essential Principles that apply to every device, and another eight relating to the design and construction of the device that may apply, depending on the particular device being assessed.

The Essential Principles are:

General principles

1. Use of medical devices not to compromise health and safety
2. Design and construction of medical devices to conform to safety principles
3. Medical devices to be suitable for intended purpose
4. Long term safety
5. Medical devices not to be adversely affected by transport or storage
6. Benefits of medical devices to outweigh any side effects

Principles about design and construction

7. Chemical, physical and biological properties
8. Infection and microbial contamination
9. Construction and environmental properties
10.  Medical devices with a measuring function
11. Protection against radiation
12. Medical devices connected to or equipped with an energy source
13. Information to be provided with medical devices
14. Clinical evidence

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