Evaluating Glucometer Manufacturers: 12 Regulatory Questions Every RA Manager Should Be Asking

Author: Jian Wang (王健), RAC
Vice President, Quality & Regulatory Affairs at VistaMed Technologies
With 18+ years navigating international medical device regulations — including FDA 510(k), CE marking under EU MDR, and ISO 13485 certification — Jian brings deep, hands-on experience in supplier qualification and quality system auditing. This article draws on his regulatory expertise to help RA managers apply rigorous compliance frameworks when evaluating glucometer manufacturers.

Last year, a distributor client forwarded me a technical file from a glucometer manufacturer they were about to sign a supply agreement with. The CE certificate looked legitimate at first glance — correct product classification, proper notified body number, professional formatting. But when I checked the directive reference line, it cited the old IVD Directive 98/79/EC, not EU IVDR 2017/746.

That single detail nearly cost them six months and a failed market entry.

The manufacturer had been operating under a legacy certificate that was approaching its expiration under the IVDR transition timeline. Had my client signed that agreement and built their European distribution plan around it, they would have been left with non-compliant inventory and no clear path to market. This is not a hypothetical risk. I have seen variations of this scenario play out multiple times since the IVDR transition began — and glucometers, as Class C IVD devices under the new regulation, sit squarely in the crosshairs.

What follows is the regulatory qualification framework I recommend to RA managers evaluating glucometer manufacturers. These are the questions I ask when reviewing any medical device supplier — refined over nearly two decades of submissions, audits, and a few hard lessons.

Key Takeaways

• Glucometers are regulated as IVD devices, which means their regulatory pathway differs significantly from general medical devices. RA managers experienced with EU MDR 2017/745 or standard FDA 510(k) processes must account for IVD-specific requirements — particularly EU IVDR 2017/746 and ISO 15197:2013.
• A valid certificate is not the same as a compliant quality system. Audit the system behind the certificate, not just the document itself.
• Strip lot-to-lot variability data, post-market performance follow-up (PMPF) plans, and software validation (for connected devices) are three areas where glucometer manufacturer qualification audits most frequently reveal gaps.
• Use the 12-point checklist at the end of this article as a working tool during your next supplier evaluation.

The Regulatory Landscape for Glucometer Manufacturers Has Shifted — Significantly

If your regulatory experience is primarily with non-IVD medical devices — blood pressure monitors, pulse oximeters, patient monitors — you already understand the rigor of FDA 510(k) and EU MDR 2017/745. I navigate those frameworks daily at VistaMed, where we maintain FDA 510(k) clearance and CE marking under EU MDR for our monitoring device portfolio.

But glucometers live in a different regulatory universe.

Blood glucose monitoring systems are classified as in vitro diagnostic (IVD) devices. In the European Union, that means they fall under EU IVDR 2017/746 — not EU MDR 2017/745. The distinction matters enormously. IVDR imposes different classification rules, different conformity assessment routes, and different clinical evidence requirements than MDR. A glucometer intended for self-monitoring by patients is classified as a Class C IVD device under IVDR, which requires the involvement of a notified body and significantly more rigorous clinical performance evaluation than was required under the old IVD Directive.

On the FDA side, most self-monitoring blood glucose (SMBG) systems are regulated as Class II devices requiring 510(k) premarket notification. The critical accuracy standard is ISO 15197:2013 (*In vitro diagnostic test systems — Requirements