28.01.2026
To the attention of all interested parties
The National Agency for Medicines and Medical Devices of Romania has been informed about the presence on the EU and non-EU market of a software developed by manufacturer Therapeak B.V. of the Netherlands, which offers patients treatment plans, following registration on the website, completion of a questionnaire and participation in 30-minute sessions with a therapist generated by artificial intelligence, depending on the patient’s stated condition.
Since the software has a medical purpose, namely the diagnosis and/or treatment of a disease, but does not meet the regulatory requirements applicable to medical devices in EU Regulation 2017/745 on medical devices (lack of a EU certificate of conformity issued by a Notified Body), the Competent Authority for Medical Devices of the Netherlands has requested the manufacturer to withdraw this non-compliant software from the EU market.
Under these conditions, the National Agency for Medicines and Medical Devices of Romania warns all interested parties to show increased attention, to not access websites referring to this non-compliant software or, if they have already accessed this software, to not consider the treatment plans generated by this software through artificial intelligence, and to follow the treatment plans established by medical professionals in Romania who have them on record for the respective conditions.