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Ensure simplified IVDR compliance and mitigate clinical study risks with Platomics safe and innovative approach.
IVDR’s impact on clinical trials
IVDR compliance has become a critical factor in EU clinical trials. Trial sponsors must ensure that contracted labs meet IVDR requirements—yet many labs lack full compliance and/or the necessary documentation.
As a result, trials are being delayed or halted, jeopardizing patient access to innovative therapies, particularly in oncology and rare diseases.
“It is the responsibility of the clinical trial sponsor to ensure compliance with relevant provisions of Union and national law, including the IVDR.”
MDCG 2022-10
In-house IVDs in clinical trials must comply with IVDR Article 5(5) and meet stringent documentation requirements.
Clinical study labs must have a public declaration of compliance with IVDR General Safety and Performance Requirements for each in-house IVDs used in clinical studies.
Labs developing or modifying these IVDs must conform to ISO 15189 or a national equivalent.
IVDR compliance for contracted labs
Without a scalable solution, the challenges that IVDR poses for clinical trials in the EU threaten to further slow or halt the development of innovative therapies —and ultimately impact patient access to life-saving treatment.
Platomics provides digital solutions and regulatory guidance to navigate contracted labs through IVDR Article 5.5 compliance without unnecessary delays. Our services cover ISO 15189 conformity and technical documentation for in-house tests.
The PlatoX platform enables labs to efficiently create all the necessary documentation for in-house IVD tests, including the resulting public declaration confirming IVDR General Safety and Performance Requirements have been met.
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