The Importance of Properly Grouping IVD Registrations Under the EU IVDR
The European In Vitro Diagnostic Regulation (IVDR) will take hold soon enough. When that happens, 80-90% of all IVDs will require CE certification by a Notified Body, up significantly from what was required under the In Vitro Diagnostics Directive (IVDD) (i.e., 10-20%). That enormous expansion has caused widespread heartburn in the industry, especially among those unfamiliar with strict new IVDR requirements.
Classification of IVD Devices Under the IVDR
The In Vitro Diagnostic Regulation (EU 2017/746) groups products according to risk: Class A, B, C, and D. These classification rules are mentioned in Article 47 and spelled out in Annex VIII. If you have not already done so, download a copy of the IVDR (Oriel STAT A MATRIX’s version contains a super-helpful linked table of contents) and go to Annex VIII.
- Classification Rules in Annex VIII of the IVDR
- Class A IVD Classification – Read Rule 5
- Class B IVD Classification – Read Rules 1-5 and then Rules 6-7
- Class C IVD Classification – Read Rules 2-4
- Class D IVD Classification – Read Rules 1-2
The classification rules in Annex VIII are quite general. Most manufacturers with IVDs that were previously classified as List A or B (both higher risk) under the IVDD will now fall into the higher-risk Class C or D under the IVDR. Likewise, many self-test IVDs will jump to a Class C designation. All of these require Notified Body intervention, but they account for only about 20% of all IVDs. The real change is with any IVD that was not on IVDD Lists A and B – commonly referred to as General List – because these were previously self-certified. Under the IVDR, about 80-90% of these self-certified IVDs will require Notified Body review as well as an associated audit.
Because the scant two pages dedicated to IVDR classification in Annex VIII generated more questions than answers, the Medical Device Coordination Group issued MDCG 2020-16 in November 2020. This 48-page guidance document takes a deep dive into Rules 1-7 and provides many examples. This document is an essential reference tool.
The Importance of the Intended Purpose Statement
Here’s why planning is so important. Section 1.1 of Annex VIII of the IVDR makes clear straight away that “Application of the classification rules shall be governed by the intended purpose of the devices.” This matters a lot because IVD companies are unique in that one technology or platform can easily be incorporated into hundreds of different products, which can trigger the need for individual CE Marking certificates for each separate intended purpose. Section 1.8 of the Annex goes on to say, “Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class.”
Based on this language alone, you can see why the intended purpose statement is so important. You need to carefully consider what it includes, how specific it needs to be, and how to determine if it can be used across different SKUs.
Group IVD Products into Families
Instead of submitting to the NB as a single IVD, an IVD system, or IVD sets or test kits, you can determine whether certain in vitro medical devices can be included together in one product registration application under one technical documentation (the technical file). In vitro medical devices may be arranged into a family, group, or cluster for the purpose of submission and product registration, which facilitates the inclusion of multiple devices in one application (the technical documentation).
If products can be grouped into families, this will enable a more efficient review with your Notified Body along with lower costs and an easier path to CE Marking. In addition, well-designed product family groupings will provide for more efficient updates to technical documentation in the future. These are some of the primary reasons great care must be taken to group devices appropriately or you’ll have a very expensive regulatory nightmare on your hands.
Although an in vitro diagnostic medical device family may have different features, the members must all have at least one common intended purpose and be made by the same legal manufacturer. For grouping products made by different affiliates, subsidiaries, or regional manufacturing sites, the corporate headquarters may be regarded as the legal manufacturer.
Prioritize and Plan Your EU IVDR Registrations
With the 2022 deadline looming, there are two forces working against IVD manufacturers:
1 – External
There have been extensive delays by Competent Authorities getting European Notified Bodies designated (approved) to conduct IVDR audits. Only a handful have been approved thus far and demand is expected to far exceed supply given the huge volume of IVDs that will require Notified Body intervention.
2 – Internal
Manufacturers may not have the staff or expertise to handle the crush of new requirements. Because the IVDR imposes new requirements on devices that did not previously require Notified Body intervention, very few will be able to take advantage of “transition” clauses in IVDR Article 110 because no reliance can be made on renewing an IVDD certificate.
Prioritization is key. Some questions to consider with your team include:
- Is this IVD nearing the end of its commercial life cycle? Should it be retired?
- When does the current CE certificate expire?
- Realistically, how many existing staff hours can be dedicated to supporting new CE submissions?
- Can new staff be hired or is there a sufficient budget to outsource compilation of technical documentation?
- Can we secure the Notified Body resources we need? If not, on what schedule can they accommodate us?
- How strong/deep is the analytical and clinical performance data associated with this device?
This article provides some helpful information on that last point about performance evaluation report requirements under the IVD Regulation.
Stay in Close Contact with Your Chosen Notified Body
If you think you’ll be able to prepare technical documentation for all of your devices and schedule audits a few months before the IVDR deadline, you can put those dreams to rest now. Remember, unlike the transition for medical devices to the EU MDR, the vast majority of IVDs will be undergoing Notified Body review for the first time. If you have not already done so, start talking to your Notified Body right away about your situation and product lineup. Don’t make a grand internal plan and then call your Notified Body; call them first, then plan, but do these both now. This will help you sequence technical documentation updates and prepare products for CE Marking. Be careful, though – if you are a Class D manufacturer, you’ll want to refer to the FAQs in MDCG 2021-04.
Don’t Wait Until the Last Minute
Here’s a conversation you don’t want to have when the IVDR deadline comes around: “Hey boss, got a minute? Yeah, it’s about our Troponin test. We need to pull it from the European market for about 6-9 months, but the good news is we can still sell in the UK!” Better fine tune that resume.
While it is true that COVID significantly slowed down the designation of Notified Bodies to conduct audits to the IVDR, you should not count on a surge of new Notified Bodies as we get closer to the deadline. There will still be a crush of manufacturers that delay until the last minute, making it even harder to get Notified Body resources at that time. Plus, any time your product is not on the EU market opens a new door for your competition to take market share. Wouldn’t you sleep better at night knowing that you have everything ready before the IVDR deadline?
Get Started Right Away
Time is short for getting your company on the right path to compliance with the IVDR. We have several resources to help you move forward quickly. Our IVDR implementation class will give you the foundational knowledge to understand what’s required and how to tackle it. If you’re an auditor, consider this class instead. If your need is more urgent, we have a team of IVDR regulatory consultants ready to help with everything from gap analysis to writing performance evaluation reports.