What can we learn from… a progressive Notified Body?

Medtech governance in Europe is highly decentralised, with product certifications also being "outsourced" to private entities (i.e. Notified Bodies). This would be complicated enough if classic Notified Bodies didn't also bring their own enormous challenges to the table: lack of availability, lack of new tech competence, lack of transparency and communication.. Companies feel they have no control over their destiny.

So what's Scarlet doing differently as a Notified Body:
1️⃣ Focus on one subject matter (digital devices only) to ensure top and uptodate competence
2️⃣ Fit the conformity assessment process around the applicant and their timelines
3️⃣ Engage transparently and pragmatically about expectations in pre-sub Structured Dialogues
4️⃣ Scale resources flexibly with externals

and, my favourite,

5️⃣ Train their trusted consultants in an independent manner in order to increase the chance of high quality submissions and enable more effective reviews.

Which other NBs do this? None that I'm aware. But please share if you know any good practices you've experienced.

Therefore, I'm particularly enthusiastic to have been part of this special training session last Friday! Not only with a like-minded NB, but among a group of 18 like-minded regulatory experts ❤️

New times and new tech need a new approach - a mantra of Edge Compliance. I hope other and new NBs will take example.

Note: I'm not affiliated but believe the initiative deserves genuine praise and broadcasting.

Thank you Dan Levy and Sandy Wright at Scarlet - also for the photo credit. Stellar job!

Regulation without borders

Starting two new client projects this week, one on food supplements in France and one on in-vitro diagnostics in Germany, both in womens health!

Very few medtech consultants would feel comfortable touching other verticals (even from MDR to IVDR). But my career started like that when, honestly, I didn't have a choice! Now it's what I enjoy the most, and what I built my agency around.

The hard competences boil down to a few common traits, irrespective of sectors, regs and countries:
➡️ Regulatory definition / classification
➡️ Manufacturing requirements
➡️ Claims and label compliance
➡️ Responsible Person / Entity role
➡️ Notification / Submission procedures
➡️ Review interaction
➡️ Launch and Distribution
➡️ Post-market reporting

After all, it's all about health accountability, and humans have really one way of expecting it - the rest is often noise.

Personally, I find it super fun to come across these analogies, transfer learnings from one area to another and even anticipate cross-sector currents. Excited to get going!

Is it cake? New bordeline guideline rundown

Here the regulatory version of “IS IT CAKE??” 🍰 - if you know the show! Featuring the European Commission’s updated guidance on borderline products published this month.

As someone whose specialty is borderline products and who loves RA developments on the edge, I spent hours digesting its 24 examples of what is or isn’t a medical device - as opposed to drugs, cosmetics, IVD, personal protective equipment (PPE), biocides,..

Frankly, I found half of the examples straightforward, and the other half.. I either struggle to understand the reasoning, disagree or find it inconsistent. Here the main reasons:

INTENDED USE vs MODE OF ACTION, WHO WINS?
MDR defines and classifies medical devices based on the former, while this guidance mostly hedges on the latter. When conflicts arise, this guidance gives priority to the mode of action. There are two, in my opinion, conflicting examples with devices that claim prevention of disease: an STI prevention app and medical examination table covers (i.e. paper roll). The first is not MD, despite processing medical records, using algorithms to assess risk, alerting peers regarding their potential for infection - because “no action on data other than communication”. The second is MD, regardless of its make - because “acts as a mechanical barrier”.

ANYTHING BUT Class I, EVER..
The myth of Class I devices continues. Only one example from here comes out as Class I MD: a rescue bag for patient transport - because "aims to support and protect, [..] avoids worsening of health". Arguably, PPE and Product for Emergency Rescue regulations could be sufficient, so what does Class I MD status really add here? On the other hand, why couldn’t some other low risk examples be Class I (e.g. STI app above, medical calculator for recurrent math)?

It's a continuous learning process for all, and access to practical guidance of this type is very helpful for the health sector as a whole - actually something that FDA does way better (writing style and formal consistency in this manual is quite disappointing).

If we held a geeky RA pub quiz on these examples, how would RA professionals, national authorities and notified bodies score? That would be interesting.

EU AI Act deployment

Since August 2nd the EU AI Act is in force. But is it?
In practice: not much today, but the clock has started. If your device includes an AI component or uses AI to support decisions it’s time to take a closer look.

For high-risk systems, including many AI-based medical devices, there’s a 36-month transition to comply, i.e. phased implementation. However, some provisions apply earlier (e.g. banned uses of AI, codes of conduct).

Here’s what I see across medtech:
1. Confusion around scope and classification, e.g. AI as a tool for CSV or as part of the intended use?
2. Assumptions that MDR = AI Act compliance, thus reactive attitude to QMS updates upon NB feedback rather than in a proactive manner
3. Teams don't know how to resource it.

Good thing is that I also see a booming AI-related offering from QARA consultants and training providers which can help if you’re stuck on any of the above points. Cool examples (among many others):

• AI-first QARA frameworks and training e.g. Johner Institut GmbH https://lnkd.in/dBSuFfie,
• AI agents for compliance-checking and even FDA review outcome prediction such as Lexim AI or Acorn Compliance,
• GenAI embedded in eQMS tools such as Formwork from OpenRegulatory or Matrix One

What would help your team implementing the AI Act? Curious to hear your challenges and to help you with the right support.