IVD Registration process

New Changes in IVD Registration Process

How Does IVD Registration Process Change with New EU Regulations?


Manufacturing of in-vitro diagnostic devices (IVD) is set to change with new regulations set by the European Union (EU). According to the recent update in the EU Regulation 2017/746, medical device manufacturers are likely to face several changes in the IVD registration process. This major update brings forth more compliance to the regulatory framework for IVD manufacturers under the EU. Registration of IVDs is expected to become more modernized under this new European regulatory system.

What is IVD registration?

Before understanding how the new IVD registration process is changing, let’s explore the process before the EU regulatory update. In the field of In-vitro Diagnostics, medical device manufacturers need to follow a process for the commercialization of IVD devices. In most healthcare markets, including the EU medical device market, manufacturers are required to follow a registration framework to get necessary approvals from the regulators.

This IVD registration process primarily involves obtaining the European CE Marking certification for IVD products. To get this approval, IVD manufacturers demonstrate the compliance of their products with the In Vitro Diagnostics Directive IVDD 98/79/EEC during the registration process.

New Changes in IVD Registration

With the recent EU regulatory update, IVD registration is set to undergo several changes. From regulatory documentation improvements to IVDR product registration outside of EU and EEA, these changes are being addressed to all IVD manufacturers and economic operators around the world.

From early-2022, the EU will enforce new rules to redefine IVDs at pre-approval and post-approval stages of the registration. Here are some key changes in the IVD registration process:


  • Medical device manufacturers can include non-medical products such as epilation lasers and cosmetic products such as contact lenses in the IVD category. This helps the manufacturers to expand their product lines and register more products for regulatory approvals.
  • Genetic test kits are also covered in the new IVD registration process. These IVD tests can be registered under patient therapeutics during approvals.
  • New rules require IVD manufacturers to demonstrate clear and higher evidence during the experimental stage of the process. Their experimental IVD products need to pass various levels of safety through effective evidence before getting approved for widespread use.
  • These new changes also affect the production of existing IVD products. Hence, manufacturers are compelled to seek recertification of existing IVD products. This emerges as a key challenge for most medical device manufacturers. If an existing IVD product fails the registration process during recertification, it can entail economic losses through product recalls.

Why is this New IVD Registration Important?

The new changes in IVDR aim to address concerns such as end-user transparency and patient safety. IVD markets are likely to be influenced by these increased expectations for clinical evidence. Under strict scrutiny, manufacturers will need to maintain and provide more data to competent authorities and notified regulatory bodies. The traceability of these products throughout the supply chain is also crucial under the new changes in the IVD registration process. The EU is also stepping up its safety monitoring through different stages of quality control and assurance. Going forward, this will emerge as a new regulatory task for IVD manufacturers in the EU and outside.

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Early diagnosis is early detection is better prognosis for COVID19

Antibody testing has emerged to be the most effective for presumptive diagnosis of COVID 19. In cases where molecular testing was negative but where there was a strong epidemiological link to COVID-19 infection and paired blood samples (acute and convalescent) showing rising antibody levels.

From detecting effective mechanism to preventing spread of infection

There have been a host of advantages associated to Antibody testing to detect COVID 19. The rapid tests can also be used to detect symptomatic, pre-symptomatic and asymptomatic infectious people before they can spread the coronavirus. As a most effective option, Rapid antigen tests, in addition to their speed, are cheap and easy to produce and therefore more broadly available than the more commonly used gold-standard PCR tests in theory. But these attributes come with a trade-off: less diagnostic accuracy.

Besides this, the rapid tests can be effective in highly controlled settings where people are tested frequently and other mitigation measures are in place. Rapid testing is often necessary to determine eligibility to donate convalescent plasma that has sufficient levels of antibodies, a therapy for COVID-19 to have passive immunization.

Advantage Spring Health Rapid Test Kits

The safety and efficacy of Spring Health has proven benefits, and the overall immune response to the vaccination is high. Individuals with previous exposure should be differentiated in evaluating the response to vaccination. Post vaccination, rapid tests could be used to detect whether and when sufficient immunity has been developed or not. These tests are also useful for determining herd immunity that is important to prevent the spread of infection to the vulnerable segments of the population.

While the current method to detect symptoms involves consultation, lab testing, and getting lab reports, the Rapid Test kits by Spring Health offer several benefits, which include:

-A detection period of 10 minutes

-Easy to operate and handle for the end-users

-No special equipment storage and transportation conditions

-Works equally well with whole blood, serum and plasma

-Tests for 2 antibodies IgM and IgG simultaneously

-Instant Field screening and

-Proven accuracy of over 98%

This gets us back to where we started, wherein it is widely accepted that IgM provides first line defense during viral infections. By providing a generation of adaptive, high affinity IgG responses the rapid tests provide for long-term immunity and immunological memory. Thus, this results in providing accurate information during the stage of infection that can lead to effective prognosis and long-term benefits.

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IVD Registration process

The Proven Benefits of Antibody Testing for Covid -19

The rapid spread of and severity of Covid-19, scientists and researchers have been aggressive in developing cheap and effective vaccine to combat the virus.




In the year gone by, companies across the globe have developed over 200 vaccines and 40 more are underway for consideration. The question however arises, is how the vaccine works, the know-how of our immune system and treatment of the infected conditions. The types of vaccination may be categorized on the basis of:  1. Using a whole germ 2. Using parts of the germ that triggers the immune system 3. Using the genetic material/part that provides the instructions for making specific proteins.

While most vaccines stimulate the body to make antibodies, some antibody-based tests for coronavirus infection may return a positive result even if you are not, or were not previously infected with the coronavirus. This is called vaccine-induced seropositivity (VISP) test result.

Antibody tests and their functions

In order to establish vaccine efficacy and vaccine-induced immune response, measuring these antibody levels in whole blood, plasma or serum could play a vital role. There are three types of antibodies created in response to infection: IgA, IgG and IgM. IgG is used in most antibody tests as it persists for the longest time and may reflect longer‐term immunity, although it is the last to rise after infection. Many tests assess both IgG and IgM. IgM typically rises quickly with infection and declines soon after an infection is cleared.

Benefits of Antibody testing

There are several advantages of antibody testing against antigen testing. Antibodies test can inform vaccination utilization and status of vaccine response at multiple levels, a) data to establish a threshold for protection or immunity, b) post-vaccination initial response, c) duration of vaccination response. The test that detected IgG is useful to detect herd immunity and previous or recurring infections.

This test detects IgG antibodies that develop in most patients within seven to 10 days after symptoms of COVID-19 begin. Since IgG antibodies remain in the blood after an infection has passed, they can be the key indicators of COVID-19 in the recent past, that can act as a protection against future infection.

It is therefore important to understand that tests to detect antibody responses to COVID-19 in the population will support the development of vaccines. For clinical diagnosis however, such tests have limited utility because they cannot quickly diagnose acute infection to inform actions needed to deter

To enable an effective vaccination strategy, it is an advocate for the use of accessible, automated, high-throughput SARS-CoV-2 serology testing to help confirm the efficacy and promote public health.

About Spring Health rapid test for COVID-19

Spring Health is one of the first companies offering rapid test kits for COVID-19 IgG/IgM. The products fulfil the highest European standards prescribed for European standards, and therefore, carry the CE mark. There are a host of benefits that can be summed up as quick detection, easy to operate for doctors and patients, and works equally and effectively with whole blood, serum and plasma.


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In Vitro Diagnostics: All that you need to know about it

Clinical diagnostics testing has entered a new phase with the availability of various tools to diagnose health conditions for effective treatment.

Clinical tests such as in-vitro diagnostics (IVDs) are clinical tests that analyze the body conditions based on the samples taken from the human body. In contrast to other devices, IVDs include products used to collect specimens, prepare and examine models in serum, urine, blood, tissue samples, and spinal fluids removed from the human body.

The new EU IVD Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces several changes for the modernization of the European regulatory system by bringing about sweeping changes to the information provided with IVD devices and their regulatory documentation. Typically, the documentation requires manufacturers to submit studies confirming the accuracy and usefulness in diagnosing a particular condition before bringing it to the market. In what follows, we analyze the commercial IVDs in terms of the processes and regulations are concerned.

Overview on the working of the IVD’s

IVDs are used to analyze human samples such as blood and saliva, either by measuring the concentration of specific substances or detecting the presence or absence of a given set of parameters such as genetic mutation or even response to an infection. The products may also be used to measure the analytes such as sodium and cholesterol using the samples in hand. Clinicians regularly use IVDs to diagnose conditions, take appropriate decisions to treat diseases, and mitigate any future possibilities of infections or diseases. A typical example here is screening tests that indicate a patient’s risk of developing a given condition in the future. 

Clinical and regulatory validation

However, some of the critical standards are to be adopted to determine the effectiveness and accuracy of the tests. IVDs must demonstrate safety and efficacy through analytical and clinical validation, which are key standards in choosing a test’s accuracy.

The analytical validity of IVD implies that the test can measure a particular analyte by detecting and measuring the presence of a given chemical compound or a hormone or genetic marker. Analytical validation calls for high specificity and accuracy as they detect and reproduce the intended results. 

<h3Clinical validation is the process for determining whether the test can accurately identify a particular clinical condition in a given patient. The test predicts the presence of or the risk of a given situation by conducting a genetic test and assessing genetic mutation either for particular cancer or any disease incidence. 

Even as the Covid-19 continues to have a reverberating effect globally, and no specific vaccine or treatment is in sight for Covid-19, several clinical trials are evaluating potential treatment. Clinical findings can throw light into assess the prognosis of the disease and the further treatment that can be undertaken. Springhealthcare Services AG is a healthcare solutions provider from Switzerland having products that are designed for qualitative detection of antigens and identification of protein antigens, that are typically detectable in the upper respiratory specimens during the acute phase of infection. Whether it is the Covid-19 Rapid IGM/IgG Combined Antibody Assay, Sars-Cov-2 Antigen Rapid Test (Swab), Sars-Cov-2 Antigen Rapid Test (Saliva) and Sars-Cov-2 Antigen Rapid Test (Saliva Spit). While they are designed for robust, easily accessible, fast and cheap tool for diagnosis, and an effective one as well. Each of the products are marked with the CE mark to fulfill the EU regulatory compliances.

CE marking in EU

The CE process for IVDs is similar to medical devices and is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU. Europe’s new In Vitro Diagnostic Regulation (IVDR 2017/746) will come into force in 2022, ushering in substantial changes to the regulatory requirements for IVDs. 

Therefore, it is vital that the IVD manufacturers to update their technical files to meet the requirements and comply with new, more stringent Regulations.

While the antigen tests are currently authorized to be performed only with nasal swab specimens placed directly into the extraction buffer or reagent, they are cheap, and reveal an active infection that is already present. Most of the currently authorized tests return results in approximately 15-30 mins. However, antigen tests do not amplify their protein signal and can get diluted when samples are mixed with liquid needed to enable the tests.

Antibody rapid test for COVID-19 lgG/lgM, on the other hand, is a combined test for IgG/IgM antibodies in serum, plasma and whole blood that does not require special equipment, storage, and transportation of samples gives accurate and reliable results in 10min compared to various other immunological tests.

About the Covid 19 Rapid Tester by Spring Health care

Typically, the tests show a 94.5% cross-assay agreement, up to 100% specificity and sensitivity where antibodies against both N and S domains are tested. This is useful for early diagnosis and early treatment of the virus.

The combined benefits of accuracy and prompt diagnosis are some of the benefits of Springhealthcare Covid 19 Rapid Tester kits. With proven accuracy of 98% the rapid one-step test kits for virus tracing has two-pronged benefits, which include: Rapid and effective diagnosis of Covid-19 infection and indication of a possibility of recent exposure to Covid-19 virus

Spring Healthcare makes it popular among healthcare specialists in Switzerland.

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Antigen vs Antibody

An antigen is any substance or organism that is unrecognized by our immune system. Any foreign invaders, such as pathogens (bacteria and viruses), chemicals, toxins, and pollens, can be antigens. Under pathological conditions, normal cellular proteins can become self-antigens. An antigen contains distinct sites on its surface, which is called an epitope or antigenic determinant. Antibodies generated against an antigen recognize and interact (in fact, the name is derived from “antibody generators) with specific epitopes via antigen-binding sites

Difference between antigen and antibody

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