Surviving a LAGeSo inspection: what three years of scrutiny taught us

8 big lessons learned

If you only read one section, read this one and learn from it:

1. Keep an open, honest dialogue with the authority and never be vague
   Answer precisely, vagueness reads as evasiveness, while precision builds trust. Ambiguity invites follow-up questions (and you will get them). Clear, well-structured answers in the right regulatory format keep speed in the process.
2. “Comply or die” applies in Germany
   Take every request, deadline and formality seriously from day one: commit, or ask for an extension with reasons. The same goes for frameworks, you comply and you prove it. There is little room for interpretation.
3. An inspection is won or lost on documentation discipline
   Consistency and completeness are everything: every claim in your intended purpose must be traceable through your clinical evaluation, risk management and technical documentation. Inconsistencies will be found, and one inconsistency can unravel confidence in your whole file, a frustration that is avoidable and that costs long-lasting discussion rounds. Make sure everything you send is well structured; it can dramatically reduce the number of feedback rounds.
4. Use precise, MDR-aligned wording in your intended purpose (Article 2(1) MDR)
   The intended purpose is the anchor of your entire technical documentation. Every term must unambiguously reflect the medical purpose of your device, vague or non-medical terminology opens the door to qualification discussions you don’t want.
5. Documentation in an online environment? Provide standalone, readable documents for the audit
   Inspectors review evidence independently. Documents full of links to other digital files don’t work, and a login to your live environment will not be accepted. Deliver self-contained, clean documents that speak for themselves.
6. Interpretation of the rules evolves over time, also on the side of regulators
   Accept this, keep your regulatory strategy under review, and discuss changes with the regulatory body you are dealing with pro-actively.
7. Know when to escalate: a second opinion (via BfArM) can be worth it
   In April 2025 we received a conclusion letter from LAGeSo no software company wants: take your device off the market within 14 days. Convinced we had done nothing wrong (supported by an accepted application review from a notified body and input from our legal advisors), we asked BfArM for a second opinion. The appeal and second-opinion routes exist for a reason and using them is a legitimate part of doing business under the MDR. Don’t panic, know your options; it is not necessarily the end of the road!!
8. Bring in legal and regulatory experts at strategic moments
   Don’t defend everything yourself for too long. Qualification, intended purpose and clinical evaluation are strategic discussions in a difficult regulatory language, experts speed these processes up.

Who is LAGeSo?

LAGeSo, the Landesamt für Gesundheit und Soziales Berlin (Berlin State Office for Health and Social Affairs), is the competent authority enforcing medical device law in the federal state of Berlin. In Germany, market surveillance of medical devices is not organised centrally: it is the responsibility of the individual federal states (Bundesländer). For manufacturers registered in Berlin, LAGeSo inspects whether devices on the market are safe, perform as intended, and comply with the MDR and the German Medical Devices Implementation Act (MPDG). Its mandate exists for a good reason: protecting the health and safety of patients, users and third parties.

Who is BfArM?

BfArM, the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), is Germany’s federal higher authority for medicinal products and medical devices, operating under the Federal Ministry of Health. Two of its roles matter in this story. First, when opinions differ on the qualification or classification of a device, BfArM can be asked to decide officially (§ 6 MPDG) - the “second opinion” route we used. Second, BfArM runs the DiGA fast-track procedure that determines which digital health applications are listed for reimbursement in Germany. Where LAGeSo supervises the market at state level, BfArM decides these matters at federal level.

Medical device in scope: our (Potential) DiGA product MyMinddistrict

Important context: the scope of the inspection was our (potential) DiGA MyMinddistrict, an aftercare DiGA for depression. While the inspection was running, we deliberately did not push the product to the market. We first wanted certainty that it would be accepted by the relevant authorities. Now it is: the product is safe, correctly classified, and the clinical evaluation report proves its effectiveness. We will now restart the remaining steps with BfArM to bring the DiGA to market. The Minddistrict Platform itself was not in scope, although many processes behind it have of course been improved based on all the feedback rounds.

Our LAGeSo timeline

The letter no manufacturer wants to receive and the second opinion that changed everything

In April 2025 we received the letter every manufacturer dreads: LAGeSo’s conclusion on the classification of our medical device was negative, and the consequence was that it would have to come off the German market. It is hard to overstate what that moment feels like after years of investment in compliance and product development.

But German medical device law offers a route that too few companies know about. When there are differences of opinion about the qualification (is it a medical device at all?) or classification of a device, BfArM can be asked to decide officially. The procedure is an application for a differentiation and/or classification decision pursuant to § 6 (2) MPDG (in German: Abgrenzung und Klassifizierung). The manufacturer, its authorised representative, the notified body or the competent state authority itself can submit it. A detailed overview of the application procedures and the respective responsibilities can be found directly in the FAQs of Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM).

We took that route, supported by strong legal and regulatory advice. In December 2025, BfArM decided in our favour; in January 2026, LAGeSo accepted the outcome and asked for updated documentation; and on 30 June 2026 we received written confirmation that the investigation was closed. In other words: a negative conclusion from a state authority does not have to be final. If you genuinely believe your qualification, intended purpose and clinical evaluation are defensible, a second opinion can put you back in the game. Don’t panic, trust yourself!

A word of advice on where you register

If you have a genuine choice in where your German entity or authorised representative is based, know that within the industry, Berlin’s LAGeSo has a reputation as one of the most rigorous enforcement regimes among the German state authorities. We say this respectfully: LAGeSo’s inspectors were professional, knowledgeable and doing exactly what they are mandated to do: protect patients. But rigour has a price for the manufacturer. The moment you are dealing with them, it is hard: long timelines, deep scrutiny, and no shortcuts. br>

There is a silver lining, and we mean it sincerely: if you survive a LAGeSo inspection, you come out the other side with one of the best compliance departments in the business. Our documentation, processes and regulatory maturity are stronger today than they ever would have been without it.

Thank you

We could not have navigated this alone. A big thank you to our advisors at Kazemi & Partners Rechtsanwälte and Bayoocare, who supported us at the strategic touch points that mattered most: the qualification of our product, the intended purpose, document consistency and the regulatory documentation underpinning our clinical evaluation. Don’t keep fighting alone for too long . Use regulatory experts who speak the same language as the authorities.

Questions about our journey? We’re happy to share our experience and provide more insight into the non-conformities we faced: compliance@minddistrict.com

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