The European Union (EU) introduced extensive changes in May to medical device and in vitro diagnostic regulations (IVDR). These new regulations, which will go into effect in 2020 for medical devices and 2022 for IVDs, are long overdue, as for some time, too many IVDs that did not perform as intended have been placed on the market in the EU. The new regulations aim to improve regulatory oversight and patient safety, illuminate the requirements for marketing devices, and help countries that follow its regulations market devices in multiple regions simultaneously.
In this first of a two-part series, we focus on what manufacturers need to know specific to changes in IVD regulations. Next month, we’ll discuss changes made to medical device regulations.
Aligning EU and FDA IVD Regulations
Overall, the EU is aligning its IVD documentation standards with those of the US Food and Drug Administration (FDA). The new IVDR clarifies IVD classification standards and the requirements for clearance of a new IVD in the EU. These changes include:
- Risk classification based on intended use
- Technical documentation requirements
- The use of IVD-specific national and international performance testing standards
- Human factor studies
- Post-market surveillance requirements
Any medical device CRO that has brought IVDs to market in the United States is already well prepared to transition IVD studies to the new European requirements. In fact, many US IVD and companion diagnostic manufacturers are already in compliance.
Three areas deserve special consideration, however, because they impact manufacturers’ design strategies from the beginning of development.
1) Risk-based Classification
The new IVDR introduces a new risk-based classification scheme, and replaces the “general IVD” designation with four new classes similar to the FDA’s three-class system: A (lowest risk), B, C, and D (highest risk).
For IVDs in classes B through D, manufacturers will need to provide technical documentation to a Notified Body (NB), prior to receiving a CE Mark, that demonstrates its scientific validity, analytical performance, and clinical performance. For instance, a manufacturer must demonstrate that its IVD can accurately detect a clinically relevant analyte in its target population.
Novella Clinical helps manufacturers design studies to anticipate questions about the applicability and safety of their IVDs within the new structure. We also help produce ancillary documents and reports to meet the associated reporting requirements.
2) Technical Documentation Requirements
Under the new regulations, the role of NBs will significantly expand, as the proportion of diagnostics requiring certification from NBs will shift from 10-20 percent to 80-90 percent. Manufacturers will need to fully redesign technical files to meet the IVDR’s new requirements and the expectations of an NB. Manufacturers who previously relied on self-certification without input from NBs will likely experience the biggest impact, especially if their products only meet the minimal criteria for compliance. Some previously cleared or self-certified IVDs may be pulled from the market.
Novella Clinical can help ensure the newly required quality systems for demonstrating a device’s safety and efficacy are in place and functioning properly. We perform gap analyses of manufacturers’ current design and development documentation for IVDs to further aid the transition to a new technical file design that meets the new, more stringent certification requirements. If a company provides acceptable IVD verification and post-market surveillance data, then it should be possible to quickly obtain NB clearance for its IVD and introduce (or reintroduce) it to the EU market.
3) ISO Standards
The new IVDR incorporates several elements of medical device ISO standards. The new regulations place an increased emphasis on integrated risk management during clinical development and post-market surveillance. Regarding usability engineering, especially, manufacturers will be required to take steps to reduce the risk of user error. To maximize patient safety, manufacturers will have to document, in a technical file, who will be using their IVD (physicians versus patients), their technical knowledge of the IVD, and their experience and training associated with using the IVD.
The ISO standards also require that manufacturers operate a quality management system. Diagnostics manufacturers will benefit from working with a CRO that has experience working in compliance with these systems, allowing for swift implementation of the regulations.
Do you have a question about the new EU regulatory standards? Ask us.
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