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The Road Ahead: Unforeseen Hurdles in EU IVD Regulation
While there is general industry agreement about the positive intent of EU MDR and IVDR, many manufacturers are now scrambling to understand the terrain of the road going forward–and they are right to be concerned. There are several factors that will powerfully impact their ability to meet strategic and regulatory timelines; some result from shortsightedness, and some from the simple fact that it is difficult to stay abreast of the change while still driving their business forward.
Scope of Regulatory Impact
The new regulation has a far-reaching impact. Strengthened quality system requirements, enhanced product traceability through the need for product identifiers, explicit formalized relationships with the supply chain, reporting in the EUDAMED database, proactive post-market surveillance, performance evaluation reports, evidence of scientific validity, and clinical performance are just a few of the major changes. Top-level management must realize the impact in terms of time, money, and portfolio on the whole of their business, and drive the implementation accordingly.
Overestimating Notified Body Access
While most manufacturers have begun to see the light, the impact of limited notified body access may not be yet fully grasped. Notified bodies are designated according to “assessment” codes that define the scope of their activities. There are over 80 IVD assessment codes, and upwards of ten codes may apply to a single device. It is very unlikely that every notified body will be designated for each of these codes. Thus, it is important to book your assessment with a notified body that you assume will have all codes relevant to your device in the scope of their designation – an independent consultant can help you find the right partnership if needed. Despite recent hopeful news about new notified body players entering the market, the destabilizing imbalance between demand and supply is likely to wreak especial havoc on small to medium-sized companies.
Underestimating the Gap
Many IVD manufacturers have a broad range of products, but they do not understand the full extent of costs in terms of remediation for existing products. A gap assessment of technical documentation against the regulatory requirements is an obvious and excellent first step. If a manufacturer has been relying on data generated for a 510(k) premarket notification, remember that demonstration of substantial equivalence is rarely the basis of, and may not meet the requirements for compliance in the EU. Also, the number of requirements to be met is not highly impacted by the risk class. It is only the amount of evidence per requirement that may change, dependent on factors including the intended purpose and degree of novelty.
"Top level management must realize regulatory impact in terms of time, money, and portfolio on the whole of their business, and drive the implementation accordingly"
Remember to also factor in the costs of certification itself. It is not yet known how many devices can be grouped together for a single conformity assessment certificate with a notified body. Each certificate will cost substantially. While the general requirements for each classification remain the same, the number of applications needed varies by class and by product type. There is an allowance for product grouping, but some product types require individual, per-product application. Unanticipated additional applications will mean unanticipated costs.
The impending complexities in the regulatory navigation and lack of notified body access could make the situation untenable for companies with limited technical files or insufficient capital, and time is not on the manufacturers’ side. The optimal time to engage with a notified body and/or perform that critical gap analysis is already past. Seek expert help if in any doubt. Manufacturers who have already begun will be one step ahead of their competition. Those that have yet to start may find themselves woefully behind, with the odds of catching up shrinking each day.