Duodecim EBMEDS Clinical Decision Support certified as an MDR-compliant medical device – Duodecim

Duodecim Publishing Company Ltd is one of the first Finnish companies to receive a CE marking for a class IIa device in compliance with the Medical Device Regulation (EU 2017/745) for its Duodecim EBMEDS® medical software. The certification was granted by SGS Fimko Oy 0598 15th Feb 2023.

Aimed at physicians and nurses, EBMEDS Clinical Decision Support offers patient-specific advice, warnings and various tools to plan and implement treatment. The system combines information stored in patient records and their attached information sources, such as test results, medication and diagnoses, and generates decision support for professionals, based on national Current Care Guidelines and other content published by Duodecim. Clinical Decision Support is integrated in all the most commonly used patient record systems in Finland.

Clinical Decision Support improves patient and drug safety by reminding of, e.g. missing or outdated measurements and check-ups, and by warning of harmful interactions of medication prescribed to the patient. The automatically completed calculators and forms save the valuable time of the professional.

The Duodecim medical device includes several functionalities, such as Health Benefit Analysis, aimed at assessing the health of a population, and symptom checkers, published as part of the CE-marked national Omaolo.fi service produced by DigiFinland Oy.

“The long journey from setting up a quality management system to receiving the CE-marking has taught us a lot. We have critically reflected on our operations and the connected processes, the finetuning and measuring of which is pivotal. Naturally, the journey continues, since a medical device manufacturer is monitored and audited regularly,” describes Quality Manager Eija Kutinlahti.

“Receiving the certification has required a substantial financial and mental investment. The commitment of employees and upper management has been vital. A high level of patient safety and customer satisfaction are built into the Medical Device Regulation, and both of them are at the core of our operations. I trust that supported by the CE-marking, our systems are competitive in the growing and highly-regulated health technology market,” says Head of Integrated Services Tuomas Lehto.

Duodecim Clinical Decision Support is used by ca. 24,000 health care professionals. The Omaolo.fi service aimed at the Finnish people is available for each of ca. five million Finns.