Free new tool launched to help medtech businesses comply with In Vitro Diagnostic Regulation
A new search tool has been launched to help medical device manufacturers comply with new EU rules regarding compliance with In Vitro Diagnostic Regulation (IVDR).
RQM+, a medical device and diagnostics focused regulatory and quality consulting firm, has devised a free thematic search tool to help users navigate the legislation using the subject areas most likely to be relevant to their day-to-day work.
Even though the MDR deadline was delayed to May 2021, the impending deadline of May 2022 for the IVDR has not changed, so diagnostics companies remain under considerable time pressure to achieve compliance with the new regulation to keep its products available on 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Failure to comply on time could result in CE mark certification being withdrawn.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 commented: “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.”
Legislation is currently drafted to define legal responsibilities, rather than to provide optimum ‘searchability’ for Regulatory, Clinical, and Quality Assurance professionals.
Using this tool, regulatory, clinical, and quality teams can save considerable amounts of administrative time and concentrate their precious expert effort on professional workflows.
The RQM+ IVDR Search Tool is available to download here.https://thiis.co.uk/free-new-tool-launched-to-help-medtech-businesses-comply-with-in-vitro-diagnostic-regulation/https://i0.wp.com/thiis.co.uk/wp-content/uploads/2021/07/2021-05-CTA-RQM-IVDR-Term-Database-Social-2.jpg?fit=900%2C470&ssl=1https://i0.wp.com/thiis.co.uk/wp-content/uploads/2021/07/2021-05-CTA-RQM-IVDR-Term-Database-Social-2.jpg?resize=150%2C150&ssl=1NewsroomSupplier NewsTrade Newsdevice,EU,IVDR,manufacturers,medical,reguations,RQM+A new search tool has been launched to help medical device manufacturers comply with new EU rules regarding compliance with In Vitro Diagnostic Regulation (IVDR). RQM+, a medical device and diagnostics focused regulatory and quality consulting firm, has devised a free thematic search tool to help users navigate the legislation...Liane McIvorLiane McIvorliane@thiis.co.ukAdministratorTHIIS Magazine