A European Union-centralized scrutiny system will be put into place for high-risk products under a new EU regulation for in vitro diagnostics that is heading toward adoption in the coming months.
Newly released pending In Vitro Diagnostic Regulations for the European Union include a special scrutiny procedure for the highest-risk, class D IVD devices and detailed performance evaluation requirements.
The IVD regulation, along with a parallel medical device regulation, was posted for public review earlier this month as the European Parliament, the Council of the EU and the European Commission have signaled support. (See (Also see "Consensus Builds For EU Reg Reforms As The Full Details Emerge" - Medtech Insight, 13 Jun, 2016.).)
The two regulations are expected to be formally adopted by the EU in about six months. But the new IVD Regulation is not expected to be in force until five years after adoption due to a transition period included in the text that accounts for the vast fundamental changes that IVDs will face under the new system compared to the current status quo. (See (Also see "New World Of Regulation Awaits IVD Companies In Europe From Coming Reforms" - Medtech Insight, 24 Nov, 2015.).)
Expert panels will be sought selectively, particularly for cases where it is the first certification for a specific type of IVD and no "common specifications" exist.
Once the regulation is implemented, an EU-centralized Medical Devices Coordination Group and, where applicable, the European Commission, will have the opportunity to scrutinize the assessment of class D IVDs conducted by notified bodies. If they identify concerns, the EU entities may request scientific advice from expert panels established by the regulation. The panels may also have been involved at an earlier stage to provide additional support to the notified body work relating to the safety and performance of the IVD device.
The scrutiny process will start when the notified body informs, via the Eudamed medical device database, a responsible national competent authority of certificates it has granted for devices designated as class D. Clarification is still needed on whether the notified body must communicate with the competent authority that oversees the EU member-state where it resides or where the manufacturer is based.
The notification to the competent authority will have to be accompanied by a wealth of documentation including instructions for use; the summary of safety and performance; the assessment report by the notified body; and, where applicable, the laboratory tests and the scientific opinion from the reference laboratory, and the views expressed by the EU expert panel. In the case of divergent views between the notified body and the experts consulted, the notified body must also include a full justification.
The expert panels will be brought into certain cases to provide views on the preliminary assessment conducted by notified bodies on the performance evaluation. From the regulatory text, it seems that the advice of the expert panels will be sought selectively, particularly for cases where it is the first certification for a specific type of IVD and no "common specifications," which are pre-specified, detailed technical requirements, exist.
The process has been designed to future-proof the regulation of IVDs, as it will provide an opportunity for regulators to share expertise on product performance and draft common specifications on the categories for devices that have undergone the consultation process. As a result, the expert panels will be reserved for truly innovative IVD devices, which might help to conserve resources.
When they are involved, the expert panels will be expected to provide their view on the laboratory testing conducted by reference laboratories, as well as the compliance of the device.
The new IVD Regulation also gives competent authorities a role in critically evaluating notified bodies' assessments of manufacturers' technical documentation, in particular their documentation supporting performance evaluation and risk management. This will be part of the national authorities' oversight and monitoring activities, and could involve sampling of relevant documentation.
In addition, under the new regulations, notified bodies will have the power to impose restrictions on the intended purpose of an IVD, limiting it to use for certain groups of patients or users or requiring manufacturers to undertake specific postmarket follow-up studies.
- A version of this article appeared in Clinica.
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