Challenges faced by manufacturers to comply to IVDR

Under IVDD (98/79/EC), 80% of IVDs were permitted to self declare by the manufacturer. The IVDR requires medium to high risk IVDs to undergo reassessment by a notified body. The new concept of classification put forth under IVDR leaves 80% or more IVDs in need of notified body assessment. 

Changes to Performance Evaluation Requirements

The performance evaluation related to clinical requirements under new regulation is complex and overwhelming. Under the old directive, manufacturers are required to provide evidence at various levels, but the new regulation details comprehensive proof of evidence that are also prescriptive. Along with demonstrating clinical and analytical performance as well as scientific validity, manufacturers must demonstrate the clinical benefits of the IVD and why it should be considered for state of the art.

After the IVDR compliance, evaluation of performance is necessary. Keeping this factor in mind, Post Market Surveillance (PMS) plans must be in place to address the creation of Postmarket Performance follow up (PMPF) plan. This helps the manufacturer to update the product’s performance evaluation in real world, eliminating any postmarket ambiguity.

Postmarket Requirements

The manufacturer’s documentation on postmarket surveillance is based on the PMS plan, outlined in Section 1 of Annex III. It must allow for the systematic gathering and analyzing of relevant data related to quality, performance, and safety. This data demonstrates continuously maintained conformity, ensures missing clinical data is captured, and helps manufacturers initiate preventive and corrective actions.

However, manufacturers may have more in place than they are aware of. If a manufacturer’s quality management system (QMS) already includes a built-in postmarket surveillance process, postmarket surveillance planning can begin. When this postmarket surveillance is paired with an understanding of the device itself — including risk assessment outputs, novelty, and complexity — the process helps establish the PMS plan.

Quality Management Systems

As the “devil is always in the detail,” and while the harmonized standard will remain ISO 13485, the IVDR has new requirements for specific plans and subsequent reports with prescriptive content.  These will need to be embedded into the quality management system and staff will need to be trained to follow the IVDR and the new procedures. Manufacturers also will need to include the IVDR in their routine internal audits before their first IVDR audit to ensure that the requirements have been addressed.

The IVDR presents an enormous change to the IVD industry, not only because it requires a significant change to technical documentation and the quality management system, but also because it changes the relationship with economic operators and their responsibilities. Manufacturers have often launched in Europe before the US; however, under the IVDR, the requirements are more tedious and will take more time for approvals to be completed, and this may change the way products are launched in the future. While there is undoubtedly a huge amount of work required to transition from the IVDD to the IVDR, manufacturers should recognize the IVDR is more complex and detailed and will require more resources to maintain as well as implement.