Manufacturers of in vitro diagnostic Medical Devices must face important news provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, for example:

• Expansion of product scope. The scope of the IVDs is extended to include devices manufactured for use within a single healthcare institution among high-risk devices. For example, diagnostic services, genetic tests and other tests which provide information on the predisposition of patients to develop a disease or on sensitivity to medical therapy.

• Reclassification of devices according to the risk. The new Regulation IVDR 2017/746 provides specific rules to correctly classify IVDs according to their degree of risk. Risk classes range from Class A for low-risk devices to Class D for high-risk devices.

• More rigorous documentation. The IVDR provides more detailed content for technical documentation; moreover, Manufacturers must collect and store post-market clinical data for continuous assessment of potential safety risks.

• Identification of a “qualified person”. In their company, Manufacturers must appoint at least one Responsible Person for compliance with requirements of the new IVDR. The company must also document the specific qualifications of this person according to the required tasks.

• More rigorous surveillance by Notified Bodies to reduce risks deriving from unsafe devices. The new classification of Medical Devices, according to their degree of risk, will require the intervention of the Notified Body for product acceptance. Nearly the 90% of IVDs, for which the “self-certification” modality is currently in place, shall be re-certified according to the IVDR Regulation. For the first time, most Manufacturers shall relate to Notified Bodies in a more rigorous field. to demonstrate the conformity of a device, indeed, the IVDR provides for stricter requirements and Manufacturers shall produce more information for the technical documentation.

• Implementation of the Unique Device Identification (UDI) for a better traceability.

• Performances evaluation to demonstrate conformity according to the IVDR. Manufacturers shall re-evaluate their IVDR devices following the new prescriptions. The Post-Market Performance Follow-up (PMPF) should be prepared. It is considered a continuous evaluation process of performances in order to update them during the entire life cycle of the device. The performances evaluation is a continuous process through which data are evaluated and analysed to demonstrate scientific validity, analytic and clinical performances.

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