For years, the strategy for most IVD companies was to go for a CE mark in the European Union because it was, frankly, a lot easier than seeking FDA clearance or approval. But that’s about to change - or at least it will in 2019, when the regulations are fully implemented.
After two public consultations, the EU published the highly anticipated, newly revised IVD regulation on September 26th. The proposed EU IVD regulation matches the scope of the current IVD Directive 98/79/ EC. It will also replace the national transposition measures, and allow for a single regulatory framework. The proposed regulation is 143 pages long, so we’ve attempted to summarize it below. You’re welcome.
First, the proposed changes clarify and extend the scope of the IVD Directive to include:
- High-risk devices manufactured and used within a single health institution (aka LDTs), which are subject to most of the requirements set out in the proposal. This includes an amendment of the “putting into service” definition to include LDTs.
- Genetic tests with a medical purpose.
- Companion diagnostics tests.
- Medical software, which is explicitly mentioned in the definition of IVDs
- Clinical evidence, which will be expanded to include the scientific validity of the analyte, validity of analytical performance, and validity of clinical performance.
Additional changes include:
- Replacing device classifications with a risk-based classification system – Class A through D, with D being the highest risk.
- Greater interaction with Notified Bodies.
- A consultation with EU member state competent authorities or European Medicine Board on review of companion diagnostics.
- A requirement for “qualified person” within in manufacturer’s organization to be responsible for regulatory compliance.
- Requiring devices to include a Unique Device Identification (UDI) to allow for traceability
If you think that all this is starting to sound like another regulatory body located in the US, then you’re right. The EU is definitely moving more towards a risk-based approach to IVDs, similar to the one used by the FDA. And the biggest changes will come in how IVDs get their CE mark and what happens once they are on the market.
Currently, most IVDs follow the self-certification conformity assessment route for CE marking. Under the proposed regulation, most IVDs will fall in either Class B or C, which will require the review of a notified body to help determine conformance. The involvement of the notified body will increase with the device class. Notified bodies will also have additional tasks, including surprise factory inspections, taking samples from production, and conducting testing and rotation of their assessment staff.
Further, the European databank (Eudamed) will become the central repository for the following information on IVDs:
- Unique Device Identifiers.
- Registration of devices including summary of safety and clinical performance for Class D devices.
- Registration of economic operators (manufacturers, authorized representatives, importers and distributors).
- Information on Certificates.
- Registration of clinical investigations/clinical performance studies.
- Vigilance system.
- Market Surveillance.
A large part of the information in Eudamed will become publicly available in accordance with the provisions regarding each electronic system. This means that consumers, regulators, and your competitors (yes them) will all have access to how your device performs - much like they do in the US.
There’s no doubt that the adoption of a risk-based classification system in the EU will increase the regulatory burden and costs for IVD manufacturers. Manufacturers whose IVDs were previously self-certified may be re-classified in a new category that requires a notified body review and approval as a pre-requisite to CE marking. And this requirement will apply to existing CE marked IVDs as well as new devices. The companies that currently develop their IVDs for global commercialization will be well positioned to comply with the proposed changes. For the others, well, let’s just say you have plenty of time to get there.