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, intermediary, regulatory specialist, or CEO of a med-tech startup. 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 the AKRA team. 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 but have offices in both Germany and New York. We support 95% of the major global players, all the way down to mid-sized firms and startups. Our expertise spans everything from hot topics like AI to Class 3 implantable and drug-eluting devices. 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—meaning they aren't sterile, don't have a measuring function, or aren't reusable surgical instruments—do not need notified body (NB) involvement, other than having an ISO 13485 MDR-compliant Quality Management System (QMS).
For those Class 1 devices needing notified body involvement (sterile, measuring, or reusable), the cost to market could be anywhere between 25,000 to 50,000 euros. This contrasts sharply with a Class 3 implantable, where you need to run studies and it is easily over a million euros to bring to market.
| Device Class | Notified Body Involvement | Est. Cost (EUR) | Typical Timeline |
|---|---|---|---|
| Class 1 (Basic) | No (Self-Declaration) | Minimal (QMS focus) | Internal processing |
| Class 1 (Sterile, Measuring, Reusable) | Yes | 25,000 – 50,000 | 3 – 6 Months (Expedited) |
| Class 3 (Implantable) | Yes | 1,000,000+ | 18+ Months post-submission |
Teddy: And what are the timelines like?
Andrew: Selection is key; you want a notified body that is predictable and transparent. Some offer tiered services, including expedited options. If you choose a large notified body with capacity, you could get to market in 3 to 6 months. However, with the current backlog, we are easily seeing up to 18 months for higher-risk devices. If you calculate development time on top of that, you are looking at two to three years.
The Regulatory Roadblocks: MDR as a Marathon
Teddy: No wonder people describe the transition to EU MDR as a regulatory marathon rather than a sprint. What is the biggest roadblock for most manufacturers?
Andrew: There are two sides. From the industry perspective, surveys from MedTech Europe highlight issues with predictability, transparency, and consistency of reviews. This uncertainty makes it very difficult for startups to communicate timelines to investors.
On the technical side, the gaps are largely around the sufficiency of clinical evidence. We see "legacy" manufacturers—those C-marked under the old MDD—struggling because their documentation doesn't meet the new MDR rigor. It's not just about more documents; it's about the authorities requiring more proactive, prospective clinical trials.
Teddy: It seems these extra trials cause startups to burn through money, forcing them to explain to investors why they are stuck in regulatory limbo.
Andrew: Exactly. This has had a knock-on effect where innovation is moving away from Europe; the US is often prioritized now. However, there is a proposal to change the MDR/IVDR to allow for a larger scope of clinical data, such as real-world evidence. They are also looking at pathways for breakthrough devices to re-promote innovation. We should see improvements over the next few years, though there is still 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: Clinical evaluation is the most common source of deficiencies. One major red flag is around safety and performance thresholds. Manufacturers often fail to identify the right outcomes or lack enough data to show they are "state-of-the-art" compared to these thresholds.
Another area is formal errors in the systematic literature review. You must use the right databases and search terms, and show a clear screening and appraisal stage following IMDRF guidance. If your appraisal isn't done according to a plan, the notified body will flag it.
Strategies and Packages for Startups
Teddy: For resource-limited teams, how can they build documentation with the same rigor as a multinational?
Andrew: Leverage technology. Use eQMS providers and technical documentation structuring tools. These tools ensure consistency; for example, if you change your "intended purpose" statement, it updates across all 15 documents automatically, preventing mismatches.
Also, scope your project right. Don't run a study with twice the sample size you actually need. Engaging experts early to determine the correct clinical path can save a year of time-to-market, which is the biggest cost for any startup.
Teddy: Does AKRA offer specific strategies or "one-stop" packages for startups that might be financially constrained?
Andrew: Yes, we are very adaptable. We offer:
- 20% Discount: Available for SMEs and startups as defined by European standards.
- Flat Monthly Fees: We offer service packages with a steady monthly pay structure over 1–2 years, which avoids the price spikes of project-based consulting and helps with financial planning.
- Flexible Support: We can do everything from writing the entire technical file to just providing coaching for internal teams.
Teddy: So, the most important thing AKRA offers startups is active flexibility?
Andrew: Exactly. We aren't a massive, rigid consultancy. We can scale our resources based on whether the manufacturer needs it "yesterday" or if they prefer a steady pace of 10–15 hours a month.
Teddy: Andrew, thank you for sharing these incredibly practical, boots-on-the-ground insights. We are thrilled to feature AKRA as a vetted specialist firm on the ElendiLabs platform.
