Joaquín Gómez Abril, technical expert in CE marking of the Notified Body (NB) for Medical Devices (MDE) Kiwa and in collaboration with GTF M. Camps, participated on 22 February in the mHealth BCN Conference.
The first edition of this congress, which has focused on mobile health applications, has been organised by the iSYS Foundation -internet, health and society- and CAMFiC -Catalan Society of Family and Community Medicine.
Joaquín Gómez carries out his professional activity at Kiwa, a Notified Body (NB), which has the power to assess the regulatory compliance of medical devices. This assessment is necessary to be able to place a medical device on the market.
mHealth BCN Conference: the full conference programme
Before starting with the lectures, the president of CAMFiC, Antoni Sisó Almirall, and the president of the iSYS Foundation, Imma Grau Corral, presented the meeting to the attendees. After the presentation, the conferences were divided into 3 thematic blocks:
BLOCK I
10:15 - 14:00 h EXPERT BLOCKThe health app experts' block, which lasted almost 4 hours, was divided into three themes. On the one hand, the App development constraints, moderated by Jesús Berdún, with the participation of 3 experts:
- Evaluation of digital health interventions. Pablo Gascón
- The App as a health product. Joaquim Gómez Abril. GTF-Kiwa
- Sustainability of projects Gabriel Antoja
The second section of the first block, which has been entitled What you can't see: interoperability, was moderated by Felip Miralles, with the following interventions over the course of 1 hour:
- What is interoperability, levels and SNOMED CT. Toni Mas
- Information architecture and archetypes. Raimundo Lozano
- ICT SISCAT, and interoperability in mHealth. Ariadna Rius
Y The last section of the first block, Of people and technology, moderated by Joan Escarrabill, had 4 participants:
- What we know about the relationship between technology and people. Manuel Armayones
- Patient experience.Joan Escarrabill
- ICT and shared decision-making. Montserrat Moharra.
- mHealth in the first person Rafael Pardo.
BLOC II
15:30 - 17:30 h RESEARCH BLOCKIn this block, moderated by Josep Basora, The panel discussed the evaluation processes of eHealth interventions. The roundtable, which was entitled title Research in progress. Research experience in progress, The following interventions were made:
- Intervention with SocialDiabetes in the NHS M. Jesús Salido y Josep Vehi
- InterSocial- Ariadna Rius
- eMPOC Mireia Sans
- Effectiveness of digital interventions in Carme Carrión
- SIMPLe Francesc Colom
BLOC III
18:00 - 18:45 h iSYScore BLOCK: In the last block, the “Annual State of Play Report: Health Apps”in Catalan and Spanish, according to the ISYScore. In addition, the 4th TOP 20 Apps in health for the 2017-2018 financial year has also been published.
After the last block, diplomas were handed out to the participants and the day was brought to an end.
But then... what has our collaborator Joaquim Gómez been talking about?
What kind of mobile Apps fall under the category of Medical Devices? Some basic concepts
After explaining the definition of medical devices, Joaquim Gómez explained that, for an app to be considered a medical device, it must improve health, even if only in a palliative way. After giving some examples of Apps that are Medical Devices, he defined for the audience the different categories of Medical Devices that exist, and defined the type of products that fall into these categories, and the key aspects for regulating these Medical Devices in the form of Apps before the health authorities.
The regulatory framework: a reminder of existing legislation
The Directive 93/42/EEC defines the essential requirements that the medical devices have to comply in order to obtain a CE marking. Once the CE marking is obtained, these products are legally allowed to enter the European market.
The European Regulation EU 2017/745, published in May 2017, will be fully operational in May 2020. Therefore, a period of 3 years is established for the adaptation of the Directive to the Regulation, and once completed, the application will be the same in all European countries.
With the entry into force of the Regulation, much more rigorous aspects will be established than with the Directive - as a reference the Directive has 60 pages and the Regulation has more than 200. If you want to know the latest news about Medical Devices. CE Marking and Health Apps, do not hesitate to contact us. Our proposal? Solutions!