There are some key requirements for an effective testing system to suit this new normal, including:

Speed, to facilitate rapid diagnostics at the point of care or testing site
Portability, to ensure testing can be carried out wherever needed, and
Reliability, to minimise false readings and transmission risks.

The CE-IVD mark is a clear indicator of the third criteria, reliability, but what does IVD approval actually mean?

What is an IVD medical device?

An IVD medical device is an in vitro diagnostic medical device intended to be used for the testing of human samples, where the results can assist in clinical diagnosis or management.

An IVD device could be a test kit, reagent, software, system or instrument – such as a qPCR cycler. Within Australia, for example, the classification of an IVD device applies under the Therapeutic Goods (Medical Devices) Regulations 2002.

The significance of the CE-IVD mark

When you see the CE-IVD mark associated with a medical laboratory instrument or test, this signifies that the device complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC). This ultimately means that the device can legally be commercialised within the European Union (EU).

The CE-IVD mark is required for any in vitro diagnostic device sold in Europe. It is considered so important because it reflects the safety, quality and performance of that medical device.

Mic: the most portable and compact qPCR IVD instrument on the market

Earlier in 2021, our own Mic qPCR thermocycler became a registered medical device with CE-IVD marking as well as approval from Australia’s Therapeutic Goods Administration (TGA). That’s particularly exciting news, because Mic is the most compact qPCR IVD instrument available on the market combining reliability, portability and speed.

At just 2kg, this mini qPCR machine is the ideal size for mobile testing labs and temporary requirements. Because up to 10 Mics can be connected and used simultaneously with excellent reproducibility, these 48-well IVD instruments can also be scaled up to suit your level of testing at any point in time. Because Mic requires no calibration or servicing, it can be placed at a remote airport, border checkpoint, hospital or medical research lab without requiring regular visits from service technicians. And thanks to Mic’s world-first magnetic induction method, standard run comes in at under 40 minutes – with 35 cycles possible in under 25 minutes.

Mic’s TGA approval and CE-IVD mark help to assure its safety and effectiveness, and will ultimately enable more labs to deliver rapid results around the world.

An ideal choice for COVID-19 diagnosis & confirmation

The Mic IVD instrument is intended to be used with CE-IVD registered clinical diagnostic qPCR kits to provide detection of nucleic acid sequences in human-derived specimens. Therefore, Mic IVD is an ideal portable PCR machine for COVID-19 diagnosis and confirmation. Almost 3,000 Mics have already been placed at border checkpoints, airports and mobile labs in more than 120 countries for the purposes of coronavirus testing.

Mic IVD can now be used in conjunction with IVD products for the purpose of COVID-19 testing. Such IVD products that have been validated with the Mic IVD device include:

LOGIX SMART Coronavirus Disease 2019 (COVID-19) Kit
CerTest VIASURE
GenMark geneMAP Covid-19
Erba Mannheim SARS-CoV-2

It’s important to note that Mic IVD is designed for use by laboratory technicians and physicians trained in molecular biology and the operation of the Mic IVD instrument, and is not designed as a home-testing device.

What else can Mic IVD be used for?

While Mic has been previously approved for Emergency Use Authorisation in 2020 for COVID-19 diagnostics, Mic IVD is now registered as a medical device and has more far-reaching applications.

As Mic IVD is intended to detect nucleic acid sequences in human-derived specimens, it can also be used for the identification and detection of a range of infectious diseases, illnesses and for research in molecular genetics.

From cancer phenotyping to the identification of candida species, diagnosis and monitoring of genetic disorders, prenatal testing and HIV testing, Mic IVD is now able to provide clear and real-time results across a diverse range of medical and infectious disease applications in Australia and Europe.

Combining Mic IVD with the Myra automated liquid handling system further streamlines medical lab work, as the two systems integrate through intuitive software for easy and high-quality data analysis without delay. You can now consider the Mic and Myra essential elements in any modern medical lab environment.

How is quality assured with Mic IVD?

Mic IVD is manufactured under ISO 13485:2016 Quality Management System. This standard requires Bio Molecular Systems to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. You can be confident that our Australian-manufactured products are ISO 9001:2015 and ISO 13485:2016 certified.

Where can the Mic IVD medical device be sold?

Together with the recent TGA approval and CE-IVD mark approval for Bio Molecular System’s Mic IVD cycler, this portable qPCR instrument can be sold in the following countries:

Australia, Austria, Bulgaria*, Belgium, Cyprus, Colombia(INVIMA), France, Germany, Iceland*, Ireland, Italy, Latvia*, Liechtenstein, Luxembourg, Malta, Netherlands*, Norway*, Poland*, Portugal, Slovenia*, Spain, Switzerland, UK (CE-IVDD)
*English is an accepted language by the user (for professional use).

Arrange a free demo or trial of Mic IVD thermocycler

Whether you’re interested in becoming a distributor for the Mic IVD cycler or would like to experience its speed, reliability and portability for your own lab environment, contact our team today and we can arrange a product demonstration or trial period to suit.

What is an IVD Medical Device? Mic Provides a Compact Option

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