(1)Earlier this year, the European Commission published new directives regulating medical devices and in vitro diagnostics. The days when most IVDs could reach the market via a relatively simple self-certification process are drawing to a close. Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
(2)For diagnostics firms, it almost certainly means additional costs in bringing tests to market, as well as potential delays as they grapple with gathering the data to achieve clearance, in addition to the time associated with having their tests reviewed. Yet some still welcome the new directives, believing that they will bring clarity to an evolving market that has been hard to monitor, based on the existing regulations covering IVDs that date back to 1998.
(3)More specifically, the new directives have abandoned the risk classification system of the older IVD directive, under which tests were classified according to lists of parameters, only a small proportion of which were monitored by European review boards, called notified bodies (NB). As many new IVDs, especially multimarker genetic panels, were not classified as requiring review under that directive, their path to market remained self-certification.
(4)Under the new regulations, IVDs will be grouped into four different classes – A, B, C, and D – based on rules, with varying degrees of regulatory approval required. While Class A devices have the least amount of regulatory scrutiny, most molecular diagnostics will fall into Class C, or, in some instances, such as various blood tests, Class D, which have more stringent prerequisites for garnering approval.Some specific examples of Class C devices are genetic tests, companion diagnostics, prenatal tests, infectious disease diagnostics, and assays for stratifying cancer patients. An example of a Class D device is a test for determining viral load, such as an HIV test. The move to this new, rule-based system will bring about an end to the old, self-certifying method, as tests in these classes will require review by NBs prior to launch.
(5)"Under the old list-based classification system, there were probably many products that were not in the proper risk classification considering their clinical impact," said Angela Tucker, vice president of regulatory affairs at Roche Molecular Systems in Pleasanton, California. "So we welcome the new regulations," she said. "We believe they are a necessary and welcome step to support innovation in the European Union."Others, though, were less enthusiastic about the new directives, and believe they may prolong the time for new tests to reach patients in Europe, a region where molecular diagnostics often reached the clinic before regulatory clearance could be obtained in the US or the Asian markets.