Navigating the EU MDR Marathon: An Interview with Andrew Gibson of AKRA TEAM
The following is a clean verbatim transcript from an episode of The Elendi Files.
Host Teddy, General Manager of ElendiLabs, sits down with Andrew Gibson, Senior Managing Consultant at AKRA, to discuss the complexities of the European medical product regulatory landscape.
Teddy: Welcome to The Elendi Files, where we navigate the complexities of the global regulatory landscape of medical products. Our goal is to help make global medical product regulations accessible to everyone, whether you’re a manufacturer, regulatory specialist, or CEO of a med-tech startup, you’re in the right place. At ElendiLabs, we connect clients with the right regulatory expertise to get products to people faster.
Today, I'm thrilled to be joined by Andrew from AKRA, a firm that has become a go-to for navigating the complexities of the European market. Andrew, could you give us a brief introduction of what AKRA specializes in?
Andrew Gibson: Thanks, Teddy. I’m the Senior Managing Consultant of AKRA. We are a consultancy focused on the clinical, regulatory, and quality issues for manufacturers of medical devices and IVDs. We are based out of Germany with offices in New York, supporting 95% of the major global players, as well as mid-sized firms and startups. We have a team of about 20 in Germany supporting European compliance, the US, and other global markets.
Costs and Timelines
Teddy: Let’s dive deeper. What are the costs and timelines like for registering a Class 1 medical device or a Class A IVD in the EU market?
Andrew Gibson: It depends on what the manufacturer is bringing to market. Class 1 devices without special functions do not need notified body involvement, other than having an ISO 13485 MDR-compliant Quality Management System (QMS). For these, the cost can be relatively lower. For Class 1 devices needing notified body involvement, it could be anywhere between 25,000 to 50,000 euros. This contrasts with a Class 3 implantable, where it is easily over a million euros to bring to market.
| Device Class | Est. Cost (EUR) | Typical Timeline |
|---|---|---|
| Class 1 (Basic) | Minimal (QMS focus) | Internal processing |
| Class 1 (Special) | 25,000 – 50,000 | 3 – 6 Months (if capacity exists) |
| Class 3 (Implantable) | 1,000,000+ | 18+ Months post-submission |
Teddy: And what are the timelines like?
Andrew: It’s important to select a notified body that is predictable and transparent. With the current backlog, we are easily seeing up to 18 months after submission. If you calculate development time, you are looking at two to three years.
The Regulatory Roadblocks
Teddy: That is quite some time. No wonder people describe the transition to EU MDR as a regulatory marathon. What is the biggest roadblock?
Andrew: Industry surveys show issues with predictability and consistency of notified body reviews. Gaps are largely around the sufficiency of clinical evidence and clinical evaluation. We also see legacy manufacturers struggling to get documentation up to the level specified by MDR.
Teddy: It seems authorities are requiring more and more clinical trials, which burns through a startup’s money.
Andrew: Exactly. Innovation in the European market has gone down, and the US is being prioritized. However, there is a proposal to allow a larger scope of clinical data, such as real-world evidence, to re-promote innovation. It is still at a proposal stage, and there is pushback from notified bodies.
Clinical Evaluation Red Flags
Teddy: Regarding Clinical Evaluation Reports (CER), is there a specific red flag that notified bodies keep flagging?
Andrew: One major red flag is around safety and performance thresholds. Manufacturers may fail to identify outcomes that lead to threshold values for the acceptability of the benefit-risk. Other red flags are formal errors in the systematic literature review—you must follow IMDRF guidance strictly.
Strategies for Startups
Teddy: Do you have advice for startups to build technical documentation with the same rigor as big companies?
Andrew: Use technological solutions like EQMS providers. Most importantly, scope your project right from the start. Engaging experts early ensures you take the correct clinical path without over-spending on unnecessary studies.
"We offer a 20% discount for SMEs in Europe and monthly service packages with a flat-pay structure to make financial planning easier for startups."
Teddy: So, the most important thing for startups is active flexibility, right?
Andrew: Yes, we are very flexible to support manufacturers on whatever they need.
Teddy: Andrew, thank you for sharing your boots-on-the-ground perspective today. We will be featuring AKRA as a vetted specialist firm on the ElendiLabs platform. Thanks again for joining us!
