In Vitro Diagnostics (IVDs) are devices and accessories that perform tests on specimens derived from the human body such as blood, urine, and tissues. The type of tests IVDs perform include:
IVD regulation and classification differs from that of medical devices
Published in May 2017, the In Vitro Diagnostic Regulation (2017/746) or “IVDR” is formally the definitive regulation governing the marketing of IVDs within the European Economic Area (EEA). The regulation is based on a lifecycle approach and replaces the In Vitro Diagnostic Directive (IVDD 98/79/EC). The new IVDR comes into force in May 2022 and brings many changes. It will employ a stricter oversight that will encompass many more products than the IVDD did. The IVDR brings in a new classification system and strengthened regulatory emphasis on clinical and performance data while elaborating guidance pertaining to post-market evaluations and vigilance efforts.
Instead of the IVDD’s list-based classification, the IVDR’s rule-based classification system divides IVDs into four classes based on their risk profiles. Classification is determined by the intended purpose and considers the risks to both the individual and public health.
Manufacturers will need to re-assess their product to determine which rules apply and justify the classification.
Compliance with EU directives and regulations and the eligibility for CE marking is assessed by a Notified Body.
Classification rules, detailed in Annex IX of the European Medical Device Regulation (MDR, EU 2017/745), relate, among others, to the following criteria:
How can we help?
Preparing the CE dossier could be a cumbersome process as it involves many different documents, templates, reports, and charts reflecting at least as many intricate processes and decision maps. GEMARMED’s experts are well versed in the practice of CE dossier compilation and can guide you through the process or assist in preparing all pertinent documentation, ensuring a successful registration of your IVD in the EEA.
The transition from the IVDD to the IVDR poses strenuous demands on manufacturers. In order to be compliant with the IVDR requirements, manufacturers will need to re-classify their IVDs, assess their Quality Management System and the technical documentation of their products and close any gaps. Conducting this gap analysis can be time consuming and costly. GEMARMED’s experts can help ease the transition process for your company and arrange the required testing for your IVD products.
We additionally offer our services as the Person Responsible for Regulatory Compliance (PRRC), a new requirement set by the IVDR to ensure regulatory compliance.