Submit Your IVDR Class B / Class A-Sterile Application Before May 26, 2027

Class B in vitro diagnostic devices and Class A devices placed on the market in sterile condition now need a notified body's sign-off under the IVDR. That's a change from the IVDD, where nearly all of these devices were self-certified by the manufacturer. To keep a legacy device on the market past its transition period, you must lodge your application with a notified body by May 26, 2027, and have a signed agreement in place by September 26, 2027.

Why this matters now

Four things make this deadline harder to manage than it looks: continued CE marking depends on it, notified bodies are still absorbing a legacy backlog, Class B is easy to misclassify, and Class A-sterile is easy to overlook entirely.

• IVDR compliance becomes mandatory for continued CE marking once your devices' transitional period ends. Miss the date, and the device loses its route to market, not just its paperwork.
• Notified bodies are still working through a legacy IVD backlog. There's no sign of a capacity crunch under IVDR today, but securing your place in the queue early protects market access regardless of how that changes.
• Class B isn't a defined risk category the way Class C is. It's the default classification that catches devices no other rule covers, which makes misclassification a real risk: if your notified body decides a device is actually Class C, that device can lose its eligibility for the transition period entirely.
• Class A sterile is the one manufacturers miss. Class A devices are normally self-certified with no notified body involved, but placing one on the market in sterile condition brings in notified body review of the quality system and technical file elements that assure sterility.

Key questions to ask right now

Before you build a remediation plan, confirm where you actually stand. Five questions surface most of the gaps we see in practice.

• Have you confirmed which of your devices are Class B or Class A-sterile, as opposed to Class C, and does your notified body agree with that classification?
• Have you contacted one or more notified bodies with an IVDR designation and a scope that covers your devices?
• Do you understand what documentation must accompany your application?
• Have you started compiling your technical documentation, including performance evaluation, risk management, and post-market surveillance plans?
• Do you know where your gaps are, and do you have a plan to close them before May 2027?
  
  

  How to prepare: a practical action plan

  Eight steps take you from an open classification question to a signed notified body agreement. Work them roughly in order: each one closes a gap the next one would otherwise expose.

  1. Confirm your classification. Revisit the classification rationale for every device you consider Class B or Class A-sterile. Class B is a residual category, not a defined risk profile, so document why each rule that could push a device to Class C doesn't apply, and align this with your notified body early. IVDR Article 47 sets out a formal classification dispute procedure, but it moves slowly, so leave time to resolve disagreements before the deadline. Misclassifying a Class C device as Class B today is a major risk to continued market access.
  2. Engage with notified bodies now. Confirm that your selected notified body covers your device type and intended use, and ask about acceptance timelines and pricing. Understand what documentation the application needs.
  3. Assess your readiness. Audit your technical documentation against IVDR requirements to find missing or outdated elements. For Class A-sterile devices, focus this review on the sterilization and sterility-assurance elements of your quality system. Is your post-market surveillance system IVDR-ready? walks through the same kind of gap check for PMS.
  4. Run a gap analysis. Map out what needs remediation, whether that's analytical or clinical performance evidence, risk evaluation, sterilization validation, or other performance data, and assign owners to each item.
  5. Develop a remediation timeline. Work backward from your planned submission date, and build in time for internal review, document updates, and any additional verification testing. Consider what post-market activities, such as post-market performance follow-up (PMPF) studies or systematic literature reviews, can contribute.
  6. Submit a complete, high-quality application. Make sure your application covers your full device portfolio with complete, current information. For legacy devices, clearly document the identity of the devices currently on the market and supply their IVDD declarations of conformity: a notified body needs this to issue a formal letter confirming your legacy devices are included in the scope of a lodged application.
  7. Finalize your contract by September 26, 2027. Once accepted, sign the agreement with your notified body to formally start the conformity assessment process.
  8. Keep your QMS obligations current. Separate from this deadline, an IVDR-compliant QMS has already been required for all IVD manufacturers since May 26, 2025, based on manufacturer self-declaration rather than third-party assessment. Make sure you can document that this requirement was met, and if you're aware of gaps, have a plan to close them.
     
     

  Even where your notified body reviews only a small sample of your portfolio's technical documentation, or only the sterility aspects of your file, the rest of your technical documentation still needs to be complete and inspection-ready.

  For a closer look at steps 2 and 3, our on-demand webinar IVDR Transition for Class B IVDs: What a Notified Body Looks For, and Best Practices for Technical Files. recorded with BSI, walks through what a notified body actually checks for and how to build a technical file that holds up under review. It's free to watch.

IVDR 2.0: what the proposed amendments mean for this deadline

In December 2025, the European Commission proposed COM(2025) 1023 to reduce the regulatory and administrative burden on manufacturers under both the MDR and IVDR, while keeping safety and performance requirements at the same level. Parliament's Committee on Public Health responded in June 2026 with a draft report and a further round of amendments that refine several points without changing the shape of the Commission's proposal. Based on that timeline, a finalized amendment is realistically expected sometime in the first half of 2027, though it still has to go through Council negotiation and can change before then. For the fuller picture of what the same proposal changes for UDI and EUDAMED, see MDR and IVDR 2.0 explained.

The amendment proposal has no impact on what you need to do before May 2027. The transitional deadlines under IVDR Article 110 are untouched by the proposal. If you want the benefit of the extended transitional provisions, you still need to lodge your application and sign your agreement on those dates, or withdraw the affected devices from the market.

One proposed change is worth examining specifically if you hold a large Class B legacy portfolio. Today, Article 48(9) requires a notified body to review the technical documentation for at least one representative device per category of Class B devices before granting a certificate, with the category driven by the device's IVD code under Implementing Regulation (EU) 2017/2185 (see MDCG 2019-13 Rev.1 for how notified bodies apply this in practice).

A manufacturer with a broad, diverse Class B portfolio can face notified body review of five to ten separate devices under today's rules, often a heavier review burden than a similarly sized Class C portfolio faces. That looks like an unintended interaction between the IVDR coding system and the sampling rules, not a deliberate risk-based choice by lawmakers. The amendment would lower the requirement to one representative device for a manufacturer's entire Class B portfolio, not one per category. With the cost of a single IVDR technical file review estimated at €38k (MedTech Europe IVDR & MDR Survey Results, 2024), that change would save many Class B manufacturers hundreds of thousands of euros in notified body fees.

What this means in practice: apply to your notified body under the current rules by May 26, 2027, regardless of where the amendment stands at that point. It's likely to be finalized somewhere between your application date and your final certification deadline of December 31, 2029, so the extent and cost of the required conformity assessment may change materially while your process is already underway. It's worth raising with your notified body now how they would handle an existing contract if the technical documentation sampling rules change partway through your assessment.

What about Class A sterile devices?

The amendment would bring a bigger change for Class A sterile devices, and it's worth watching closely. Under the current proposal, Class A sterile devices would drop notified body involvement altogether. Recital 30 of the proposal gives the reasoning directly: because Class A sterile devices are low risk, notified body involvement for them should be removed. They would then move to the same self-declaration route as non-sterile Class A devices.

Until the amendment is formally adopted, proceed on the basis that today's rules apply: notified body review of your quality system's sterility aspects remains a requirement, and the application and contract deadlines above still apply to your Class A-sterile devices. Monitor the legislative process, but don't act as though the change is already in effect.

Whether the amendment will be in force by May 26, 2027 isn't clear yet. That means the safe approach for continued market access is still to plan for lodging a formal application with a notified body by the deadlines above, even though this obligation may disappear not long after.

One question the current draft doesn't resolve: the extended transitional timelines in Article 110 apply only to legacy devices that require notified body certification. If Class A sterile devices no longer need one at all once the amendment applies, then, as the proposed text stands today, they wouldn't be eligible for the extended transitional timelines, and would fall under the same regime non-sterile Class A devices have followed since 2022. A derogation or transitional regime to give manufacturers enough runway seems likely, but it isn't written yet.

Why expert support matters

Bringing in regulatory expertise early saves money and time: it prevents multiple review rounds and catches a classification problem before your notified body does. A complete, “one-time-right” application moves through the process faster and skips the rework that comes from getting it wrong the first time.

How we can help

We support IVD manufacturers to:

• Confirm and defend Class B and Class A-sterile classification rationale
• Prepare and submit complete applications to notified bodies
• Review existing technical documentation and identify IVDR gaps
• Build a focused remediation plan
• Engage effectively with notified bodies from day one
• Run a QMS gap assessment for IVDR, including IVDR mock audits, and implement the resulting mitigation activities

Our goal is “one-time-right”: a clean, concise, compliant submission and conformity assessment process that accelerates your transition and cuts unnecessary cost.

This piece is part of our ongoing IVDR transition coverage. If you're managing a Class C portfolio too, see Time Is Running Out: Submit Your IVDR Class C Application Before May 26, 2026. For broader IVD regulatory support, see our IVD regulatory consultancy page.

Don't wait until 2027 to start. Contact Qserve today to start your IVDR readiness review, and get your application ready to submit well ahead of the May 26, 2027 deadline. Let's make your transition to IVDR smooth, strategic, and successful.