{"id":677,"date":"2022-11-09T23:26:44","date_gmt":"2022-11-09T22:26:44","guid":{"rendered":"https:\/\/playground.websplash.de\/quinnhealthcare\/?page_id=677"},"modified":"2022-11-21T04:13:22","modified_gmt":"2022-11-21T03:13:22","slug":"performance-studies-for-ivdr","status":"publish","type":"page","link":"https:\/\/www.quinnhealthcare.com\/en\/performance-studies-for-ivdr\/","title":{"rendered":"Performance Studies for IVDR"},"content":{"rendered":"
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Titel<\/span><\/h1>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n
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On May 25, 2017, the European Directive 98\/79\/EC was replaced by the European In Vitro Diagnostic Device Regulation (abbreviation: IVDR). Unlike the Medical Device Regulation (MDR for short), which was already implemented as of May 2020, the IVDR is only mandatory after a 5-year transition period.

But this transition period is shorter than it seems. Those who do not immediately take care of the required validations, performance reviews and documentation will soon no longer be able to sell and use their products from the diagnostics sector on the market. The regulation here does not differentiate between new diagnostic products and those already on the market, which means there is no assurance of the status quo and manufacturers must evaluate, verify and, if necessary, certify all products for their risk class.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n

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Quinn Healthcare can provide comprehensive support and guidance during this process.<\/p>\n\n\n\n

Gap Analyse<\/h2>\n\n\n
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