Diagnostic support algorithms, DTx, prescription software, LLMs as Medical Devices… How to obtain CE marking for a medical device embedding AI? Classification, compliance process and articulation with the AI Act: the complete overview.
Digital medical devices (DMDs) embedding artificial intelligence (AI) are multiplying in the healthcare field, and this is good news for the efficiency of our healthcare system and for patients.
What are the regulatory requirements in force for these SaMD (Software as Medical Device) embedding AI?
In this article, we offer you concrete examples of AI-based Medical Device Software (MDSW) and their classification under MDR 2017/745 or IVDR 2017/746, as well as the process to bring them into compliance.
Among AI-based medical devices, the most common are:
Diagnostic support algorithms, notably in radiology (46.9% of AI-based devices approved by the FDA¹), oncology (25%¹), neurology (15.6%¹), dermatology or genomics.
➡️ Classification (a priori): IVD MD under IVDR 2017/746, often risk class C or D.
Patient prioritisation systems in hospital services or in outpatient medicine, using risk scores to recommend care, medication dosages or vaccination reminders.
➡️ Classification (a priori): MD under MDR 2017/745, class IIb.
Insulin dosing applications
➡️ Classification (*a priori*): MD under MDR 2017/745, class IIb.
Prescription support software (PSS) assisting the doctor in writing prescriptions, based on drug databases.
➡️ Regulatory status (a priori): this is indeed an MD according to the HAS under MDR 2017/745, class IIa or IIb.
Gamified patient applications (DTx), offering a rehabilitation programme or personalised and evolving follow-up based on the patient's profile and progress.
➡️ Classification (a priori): MD under MDR 2017/745, class I or IIa.
Self-diagnosis applications, notably for mental, dermatological or other illnesses.
➡️ Classification (a priori): MD under MDR 2017/745, class IIa.
Some AI software still sits in a borderline zone and is not always CE-marked or FDA-approved. A few examples:
➡️ Regulatory status (a priori): it is not a medical device as long as the tool provides general information, equivalent to that found in a textbook or an official guideline, without applying it to an individual case. It becomes a medical device under MDR 2017/745 (class IIa or higher, Rule 11) as soon as its response concerns a specific patient and guides a diagnosis, a treatment, or the decision to seek medical care.
➡️ Regulatory status (a priori): the software becomes a medical device under MDR 2017/745 (class IIa minimum, Rule 11) as soon as it sorts, interprets, or creates medical information used as a basis for therapeutic decisions (for example, clinical summaries in the patient's file that will be used to make decisions during future consultations).
⚠️ European authorities do not all take the same view on this issue:
In Sweden, the Medical Products Agency (Läkemedelsverket) considers that a system which does not merely record and transcribe the exchange verbatim, but uses AI to process and compile patient-specific medical information that is then used for care decisions, is likely to fall under medical device regulations.
In the United Kingdom, by contrast, the MHRA published guidance on AI scribes on 29 July 2026 that, in practice, reverses NHS England's position that tools summarising patient–clinician interactions were medical devices. According to the MHRA, products intended solely for transcription, consultation summaries, letter drafting, or suggesting clinical codes subject to clinician review are not medical devices. However, a product remains a medical device if it suggests diagnoses or treatments, or if it triggers an automatic action (prescription, referral) without prior review by a clinician.
CE marking is mandatory for Medical Devices embedding AI as soon as a clinical benefit is claimed.
The assessment process is based on the following steps:
1️⃣ Implementation of a Quality Management System (QMS) compliant with ISO 13485 and MDR 2017/745 or IVDR 2017/746.
2️⃣ Building the Technical File (TF) demonstrating the safety and performance of the API/Module/Software, in compliance with European regulatory requirements.
3️⃣ Compliance with the AI Act, with progressive harmonisation between the requirements of the AI Act and those of MDR 2017/745-IVDR 2017/746
4️⃣ Question your Notified Body (NB) to find out whether it plans to be designated under the AI Act, as none is yet designated to date.
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¹ Source: Benjamens, S., Dhunnoo, P. & Meskó, B. The state of artificial intelligence-based FDA-approved medical devices and algorithms. npj Digit. Med. 3, 118 (2020). https://doi.org/10.1038/s41746-020-00324-0
