Every day, regulatory, clinical, quality, and marketing teams at diagnostics manufacturers must refer to the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). To make this process easier, a new, freely available IVDR filtering tool is being offered to the market by RQM+, a medical device and diagnostics-focused regulatory and quality consulting firm. The tool has organised the IVDR by key themes and allows users to navigate the legislation using the subject areas most likely to be relevant to their day-to-day work.
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Even though the MDR deadline was delayed to May 2021, the impending deadlines for the IVDR have not yet changed, so diagnostics companies remain under considerable time pressure to achieve compliance with the new Regulation to keep their products available on the EU marketplaces. Failure to comply on time could result in CE mark certification being withdrawn. Any way, therefore, to make regulatory preparation more efficient will benefit the whole diagnostics industry to participate effectively in EU markets.
Legislation is drafted to define legal responsibilities, rather than to provide optimum ‘searchability’ for regulatory, clinical, and quality assurance professionals. RQM+ has drawn on its wide-ranging and in-depth expertise to overlay IVDR with thematic metadata which categorises each section by fundamental compliance themes. Using this tool, regulatory, clinical, and quality teams can save considerable amounts of administrative time and concentrate their precious expert effort on professional workflows.
Providing this tool free, for the general benefit of the diagnostics industry, is the initiative of Nancy Morrison, RQM+ Executive Director, Regulatory & Quality Consulting Services. She notes: “There’s nothing more frustrating than to have to spend time searching through legislation to gather the key sections (or even sentences!) for each phase of regulatory compliance. That’s something I’ve even been told by regulators and notified bodies! Many colleagues across the sector have already been using our IVDR search tool, and we look forward to adding its MDR equivalent soon. In this way, our initiative can become even more worthwhile.”
The RQM+ IVDR Search Tool is available to download here.