IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland

Abstract

IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone.

A Comparative Analysis of Molecular Biological Methods for the Detection of SARS-CoV-2 and Testing the In Vitro Infectivity of the Virus

“…The nOne-Step RT PCR assay was theoretically developed at the beginning of 2020, but normative restrictions (REGULATION (EU) 2017/746) prevented its routine application in SARS-CoV-2 diagnostic practice. With the introduction of the IVDR Regulation (EU) 2017/746), the problems in this regard may become deeper [ 56 , 58 ], as in any future pandemics, laboratories (research and private ones) would not be able to respond independently, promptly, and adequately to the situation. This has fueled criticism against lobbyism in the new EU legislation for allowing only private companies to perform such activities in the EU [ 56 , 58 ], thus, allegedly, paving the way for the privatization of knowledge and scientific research.…”

“…With the introduction of the IVDR Regulation (EU) 2017/746), the problems in this regard may become deeper [ 56 , 58 ], as in any future pandemics, laboratories (research and private ones) would not be able to respond independently, promptly, and adequately to the situation. This has fueled criticism against lobbyism in the new EU legislation for allowing only private companies to perform such activities in the EU [ 56 , 58 ], thus, allegedly, paving the way for the privatization of knowledge and scientific research. Concerns have been voiced that with this legislation, along with the proposed international agreement on pandemic prevention and preparedness [ 57 , 59 ], any efforts for laboratories to develop methods such as this one and others will become futile [ 25 , 26 , 27 , 28 , 58 , 59 , 60 , 61 ], as will their actual application in helping people to adequately control diseases, thus making the EU dependent on corporations and the WHO.…”

“…This has fueled criticism against lobbyism in the new EU legislation for allowing only private companies to perform such activities in the EU [56,58], thus, allegedly, paving the way for the privatization of knowledge and scientific research. Concerns have been voiced that with this legislation, along with the proposed international agreement on pandemic prevention and preparedness [57,59], any efforts for laboratories to develop methods such as this one and others will become futile [25][26][27][28][58][59][60][61], as will their actual application in helping people to adequately control diseases, thus making the EU dependent on corporations and the WHO.…”