Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for in vitro diagnostics (IVD) rather than a bureaucratic quagmire. The sweeping changes being made to risk classification will be complex and time-consuming. The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.
The current IVD directive lists the devices considered to be of high risk or the highest risk. These lists exist because at the control level, a distinction must be made based on the risk different IVDs pose, so as to properly allocate authorities’ limited resources. Those IVDs that would pose a high risk to patients or public health if they were to fail are for good reason the focus of control by authorities.
Although the current system of lists has the advantage of clarity (a device is either on the list or not and there is little room for interpretation) it has proven difficult to keep these lists up to date.
The new system proposed in collaboration with the GHTF (Global Harmonisation Task Force) replaces these lists with a set of rules. Essentially, if an IVD plays a role in maintaining public health (for instance, ensuring the safety of the blood supply) it is considered of the highest risk class. Classification will be based on the impact diagnostics have on patients, where assays for the diagnosis and management of life-threatening diseases will be considered to be higher risk than routine biochemical analysis. The new set of conformity assessments stemming from the classification will result in much stricter manufacturer oversight by third party notified bodies, which will be inspecting a much wider range of facilities and reviewing the designs of more IVDs than ever before. Following the revision, it’s expected that up to 90% of all IVDs will be subject to some level of review by notified bodies.
Transitioning into these and other key changes encompassed in the new regulation will take time and resources. Authorities, the industry and labs will not be able to adapt to the new rules governing the IVD world overnight. On the one hand, all of these changes will provide benefits in the regulation of in-vitro diagnostic devices, and as such it would be beneficial to expedite their implementation. On the other, an implementation that is carried out too quickly could lead to unnecessary increases in the cost of IVDs, and could also potentially result in some level of disruption in device supply.
The Australian Therapeutic Drugs Authority (TGA) is currently further along in the process of implementing a similar system. They have had to add an additional year to its implementation schedule, bringing it to a total of five years to transition to a new, also GHTF-based classification model.
Since the medical devices framework is being revised at the same time as the IVD regulation, it is tempting to compare the two processes or even regard them as one and the same. However, the changes to IVD regulations will be much more profound, as the adjustments are meant to reflect scientific and technological progress, and cannot be implemented at the same rapid pace as the medical devices framework.
An optimal transitioning period would be staggered, ensuring that implementation is gradual but constant throughout that period, and maintaining safety throughout the system.
- 0-6 months, notified bodies will be subject to stricter control measures and will have to demonstrate competence in the specific fields in which they will be operational. It is quite possible that not all notified bodies will be maintained following these requirements.
- 6-12 months, national authorities across Europe will need to establish and begin employing better mechanisms for cooperation to ensure the system is truly pan-European, and to safeguard European citizens across the union. In addition the authorities should have by this point agreed rules of implementation necessary for the practical adoption of other aspects of the legislation.
- 12-18 months, manufacturers will need to have implemented the new system for unique device identification. This will enable IVDs to be traced throughout the supply chain all the way to the laboratories where they are ultimately used. Because of the new rules, laboratories may need to adapt on how they track their use of supplies. This aspect represents both an opportunity and a challenge.
- 18-24 months, the new rules for vigilance would kick in. Coupled with unique device identification, this will allow for much better monitoring and reporting of incidents across Europe to better identify trends and potential health concerns.
- 24-60 months, remaining provisions would be fully implemented. These provisions include changes to the way in which in-house assays are regulated, the adoption of the new conformity assessment and classification rules, and the establishment of clinical evidence for all existing devices.
In practice, this will mean that the majority of IVDs will need to be modified at some level before compliance with the new regulation is possible – even if that only means including additional information regarding the clinical evidence of the device and updating the labels to reflect the involvement of notified bodies in the assessment of the devices.
Other jurisdictions seeking to implement this kind of regulation for IVDs (such as Australia’s Therapeutic Goods Administration) have shown that a five-year transition period is necessary to ensure that all stakeholders are able to comply fully with new requirements. The staggered approach proposed by the European Parliament will ensure that key safety provisions are rapidly implemented, while also allowing sufficient time for the more complex implementation of the rest of the legislation.
– Jesús Rueda Rodríguez, EDMA, Regulatory Affairs Director
