In Vitro Diagnostics,
Made Clear Worldwide

What's the most efficient order to pursue IVD approvals across multiple countries?

There's no single right order. It depends on which markets you need first commercially and which approvals other regulators are willing to recognise, since a CE mark or FDA clearance can unlock faster reliance routes elsewhere. We help clients sequence markets so the approvals secured first do the most work opening doors to the rest, rather than treating each country as a standalone project.

Why is EU IVDR classification stricter than other regions' IVD rules?

The EU's IVDR moved to a risk-based Class A to D system with far more Notified Body involvement than most other regions currently require, making it one of the toughest regimes globally to satisfy. Classify and build evidence to IVDR's bar first, and that work generally covers you comfortably in markets with lighter requirements. The reverse isn't true.

Can one performance evidence package work across multiple countries?

Largely, yes, if it's built well. A performance evidence base aligned with CLSI guidelines and structured around the internationally harmonised IMDRF classification model can generally be adapted for multiple markets rather than rebuilt from scratch each time. Some region-specific data or formatting is usually still needed, but the core scientific and clinical evidence travels.

What is the IMDRF and why does it matter for global IVD strategy?

The IMDRF (International Medical Device Regulators Forum) is the body behind the harmonised risk-based A to D classification model that many countries now base their own IVD rules on. Understanding your IMDRF-aligned class gives you a reference point that translates across borders, even though each market still layers its own local requirements on top.

Do I need a local representative in every country I sell my IVD in?

In most markets, yes. A local representative, authorised representative, sponsor, or agent (the exact title varies by country) is typically required to hold your registration and act as your in-market contact. We help clients work out exactly which markets need what kind of local representation and put the right arrangements in place.

Should I get FDA or CE approval first if I'm planning global expansion?

It depends on your priority markets, but many manufacturers front-load whichever approval unlocks reliance in the most other territories they care about, whether that's CE under IVDR or FDA clearance, since a growing number of regulators accept these as supporting evidence. We're not just here to tell you what you can't do; we map this out early so the first approval you chase does the most heavy lifting globally.

Do I need to repeat performance evidence or testing for every country I sell my IVD in?

Not always from scratch. Performance evaluation evidence is often reusable across markets provided the test, its intended use and its performance claims stay the same, and some regulators will lean on an existing CE mark or FDA clearance rather than demanding entirely new evidence. What does still need addressing per market is local technical documentation and registration, and in some cases additional performance data to satisfy a specific regulator's classification requirements. We review what you already have before recommending any new work.

Do you review marketing claims, social media, paid ads and influencer content, not just your product listing?

Yes. Claims compliance doesn't stop at your product listing, so we review marketing wherever it appears, including your website, social media, paid advertising and influencer or affiliate content, since regulators treat all of these as regulated marketing for an IVD. It's often overlooked material like a website claim or a paid ad headline that creates risk, even when the technical file itself is solid.

Do you monitor for upcoming regulatory changes, or just handle one-off compliance projects?

Yes, horizon scanning is part of our ongoing support. We track upcoming changes to UK IVD regulation, EU IVDR and other regional requirements across the markets you sell in, so you hear about a change that affects your product before it becomes a compliance problem, rather than finding out after the fact. It's built into our ongoing compliance service rather than something you need to ask for separately.

What trade associations is Taylored Consultancy a member of?

We're members of PAGB, the trade association for the UK consumer healthcare industry, which represents OTC medicines, self-care medical devices and food supplements. That connection keeps us close to how diagnostics regulation is actually developing, which feeds directly into the advice we give clients.

Still have questions? Contact us and we'll be happy to help.