A new filtering tool has launched to help medical device manufacturers navigate the EU’s upcoming In Vitro Diagnostic Regulation (IVDR).
Launched by RQM+, a medical device and diagnostics focused regulatory and quality consulting firm, the free tool has organised the IVDR by key themes to help users read the legislation using the subject areas most likely to be relevant to their day-to-day work.
With a deadline of May 2022, medical device manufacturers and diagnostics companies remain under time pressure to achieve compliance with the new regulation to keep their products available under the EU marketplaces.
Failure to comply on time could result in CE mark certification being withdrawn.
Nancy Morrison, RQM+ executive director, Regulatory & Quality Consulting Services, said: “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 current legislation is drafted to define legal responsibilities, rather than to provide optimum ‘searchability’ for regulatory, clinical, and quality assurance professionals.
RQM+ has overlaid IVDR with thematic metadata which categorises each section by fundamental compliance themes.
Using this tool, regulatory, clinical, and quality teams are set to save administrative time and concentrate their precious expert effort on professional workflows.