As the manufacturer of legacy IVD devices, you face the challenge of reclassifying your product portfolio using the new risk-based classification rules, outlined in Annex VIII of the IVDR 2017/746. There are still some grey areas, which I shall clarify during this post but this new system is a huge improvement on the previous classification rules, set out in the IVD Directive 98/79/EC.
The historical development of the IVD device classification
During the 1990s the EU began to establish the regulatory framework for all medical devices (including IVDs), developing a classification system was to regulate the risk they pose to human life. This principle was incorporated into the medical device directive (93/42/EEC) more so than with the IVD directive (98/79/EEC), which instead defined lists and generic categories. Because of This, the disparity was one of the many reasons for the need for a modern up-to-date IVD regulatory framework in the EU. The Global Harmonisation Task Force (GHTF), now superseded by the IMDRF, had developed a sophisticated classification system for IVDs. This has emerged within Australian and Canadian IVD regulations. It was, therefore, no surprise to see this as the basis for the new set of rules we see in Annex VIII of the IVDR 2017/746.
There are four risk classes, A, B, C & D. Class A presents the lowest risk and D the highest. Feeding into this are seven classification rules (Annex VIII). Other parts of the IVDR are used to direct the conformity assessment process once a device is classified. Ultimately to achieve the CE mark.
However, as the pace of medical technology has accelerated, a large and diverse group of IVD devices has amassed in the ‘General IVD’ category. The requirements of the directive have inadvertently allowed them to avoid any kind of regulatory scrutiny, instead of being self-certified by the manufacturer (or their representative). This has, therefore, resulted in the reported numbers of devices of this kind to represent between 80 and 90% of all IVDs. Considering this, alongside the vagueness of the essential requirements and performance characteristics, it’s not surprising there are a substantial number of legacy devices that may not have been validated as they should have.
From my own experience in the industry, it is not until an organisation steps outside of the cosy ‘General IVD’ bubble and starts to deal with global medical device regulators, that they realise the vast gaps in their legacy device performance characteristics. A painstaking process to go through, but ultimately it is absolutely right for the IVD Regulation to have been conceived. This facilitates the roll out of higher standards, including those recommended by the IMDRF (formerly GHTF), ensuring the end user is only exposed to safe and effective devices of the highest order.
What then is the fate of this kind of device and what of the other types?
The highest risk devices under the directive have generally been either in the Annex II List A or B classes, the majority reclassified as Class D. Manufacturers of this kind of device are in for less of a shock than those who have self-certifying General IVDs, because they have a long experience of working with a notified body. On the other hand, for the ‘self-certs’, this a big step up. The new rules reclassify a big group into either Class C or Class B. Both of which will introduce the need for a notified body to deliver the CE Mark status.
- Quality management system (Art. 10.8).
- Post-market surveillance system (Art. 78.1).
- Performance evaluation (Annex XIII, Part A, Section 1).
- General Safety and Performance Requirements of Annex I (Art. 5.2).
- The risk class and the justification for the classification rule(s) must appear in the technical documentation (Annex II, Section 1.1f).
- The risk class must appear on the declaration of conformity (Annex IV, Section 5).
- Registration in Eudamed with an indication of the risk class (Annex VI, Part A, Section 2.8).
- Quality management system procedures must cover classification (Annex IX, Chapter I, Section 2.2c).
- Certificates issued by the notified body shall identify the risk classification of the devices concerned (Annex XII, Chapter I, Section 4).
- Various documents related to performance studies must identify the risk class of the device (Annex XIV, Chapter I, Sections 1.10, 1.12 and 2.1).
Examples of Specific Requirements by Class
- Special scrutiny of conformity assessment (Art. 50).
- The periodic safety update report (PSUR) (see below) must be submitted electronically to the notified body via Eudamed where the notified body must file its evaluation of the PSUR (Art. 81.2).
- The involvement of designated EU reference laboratories is a major change. They will verify the performance claimed by the manufacturer (Art. 48.5) and test samples (Art. 100.2).
Classes C and D
- Drawing up a summary of safety and performance (Art. 29.1).
- Performance evaluation reports must be updated at least annually (Art. 56.6).
- The summary of safety and performance must be uploaded to the Eudamed database (Annex VI, Part A, Section 2.11).
- The PSUR must be made available to the notified body and the competent authorities upon request (Art. 81.3).
- Member States may request designation of reference laboratories for the verification of the performance claimed by the manufacturer and the compliance with the applicable Common Specifications (Art. 100.3).
Classes B, C and D
- When registering in Eudamed (Annex VI, Part A, Section 2.4), the economic operators must indicate to the Member States where the device is or is to be made available.
Classes A and B
- The post-market surveillance report must be updated when necessary and made available to the notified body and the competent authority upon request (Art. 80).
- For single-use devices, the Unique Device Identification (UDI) carrier can be on a multi-unit packaging instead of individual unit packaging (Annex VI, Part C, Section 4.3).
Requirements for Specific Device Categories
By the way they may be used, there are requirements that apply to certain categories of devices:
- Companion diagnostics
- Performance studies
- Near-patient testing
- In-house devices manufactured by and used in EU health institutions.
Advice on Classification Strategy
The clock has been ticking for some time and for manufacturers of legacy devices and SMEs entering the IVD Industry. The following stepwise recommendations, relating to classification, are relevant to both:
- Determine the intended purpose of the device.
- Ensure that the performance of the device and related scientific validity can be demonstrated. Remember each claim that you wish to include in the product literature must be backed up by valid evidence.
- Use the classification rules to determine which is the highest risk class applicable to the device.
- Identify compliance requirements resulting from the risk classification process.
- Conduct a gap assessment between these requirements and for legacy devices, their current compliance to the directive.
- Prepare an implementation plan and timeline, outlining how gaps are to be met.
- Identify and engage with a Notified Body to reach an agreement on both your device risk classification and implementation timeline for conformity.
- Follow implementation plans, obtain CE Mark.
Challenges and How IMed Can Help
In summary, this radical change to the risk classification system will result in a big shift towards increased scrutiny by European Regulatory Authorities. Your management teams need to make some informed decisions about your current device portfolio. This willcome at a cost and increase resources to implement the transition. From a business perspective, do all of your products bring in enough revenue to warrant remediation to new compliance requirements or maybe it’s time to withdraw some from the market? How long are remediation projects going to last and do you have enough resource to facilitate their completion?
From the notified body perspective, things are not looking too good at the moment. The numbers qualified to review and inspect IVD devices is insufficient to cope with the inevitable tidal wave of new clients and devices coming their way. There will be more by the end of the transition period in 2022, but probably still not enough. New and existing IVD manufacturers should factor this into business plans and timelines.
Our IVD consultants here at IMed have experience with assisting manufacturers of legacy devices in their preparations for the transition to the IVDR. Call us now on 01295 724286 or email us at email@example.com to discuss this topic or any other IVD queries you may have.
IMed QA & IVDR Consultant