Regulatory affairs

Note on medical-device advertising

OPT RETINA S.L. was founded in 2014 as a MedTech company with a healthcare-purpose software platform. The company is not a traditional healthcare center and does not provide in-person ophthalmology care as a clinic.

As recommended by the Spanish Retina and Vitreous Society for retina-screening platforms:

To avoid referral bias, telemedicine platforms should remain independent from specific eye-care centers, and delivered reports should not reference specific ophthalmology clinics. ( view document )

Independence and compliance framework

OPT RETINA develops and markets healthcare software and operates under a medical-device manufacturer license issued by AEMPS.

Professional UpRetina information is intended exclusively for qualified healthcare professionals and access to professional content is subject to prior gate control.

Healthcare activity and authorized center

Remote retina-screening activities carried out by collaborating retinologists of OPT RETINA, S.L. are covered by the healthcare authorization of Institut d'Oftalmologia Clinica Girona (OFTALIS), a center authorized by the Directorate General for Professional Regulation and Healthcare Regulation of the Generalitat de Catalunya.

This relationship, formalized through an active services agreement, supports the teleophthalmology healthcare activity associated with the company's professional services.

Center

Institut d'Oftalmologia S.L.P. (OFTALIS)

Trade name

Institut d'Oftalmologia Clinica Girona

Address

C/ Juli Garreta, 13-15, 17002 Girona (inside Clinica Girona, COC H17001491)

Tax ID

B-17356932

REGCESS code

E17610503

Authorization file

98588

Authorization date

7 July 2017

Manufacturer identification

Company name

OPT RETINA, S.L.

Registered address

C/ Las Palmas, 11, 08195 Sant Cugat del Valles (Barcelona, Spain)

AEMPS license number

6887-PS

SRN

ES-MF-000019568

Email

info@upretina.com

Intended purpose of UpRetina

UpRetina is a standalone medical device software intended to support healthcare professionals in retina screening and early detection through the analysis of fundus images captured with non-mydriatic cameras, in order to support referral decisions to ophthalmology specialists.

Technical and commercial product information is intended exclusively for qualified healthcare professionals. Access to professional content is controlled beforehand.

Regulatory framework

• Law 14/1986, General Health Law.
• Law 34/1988, General Advertising Law.
• Royal Legislative Decree 1/2015 on medicines and medical devices.
• Regulation (EU) 2017/745 (MDR) on medical devices.
• Royal Decree 1591/2009 on medical devices.
• Royal Decree 192/2023 on medical devices.
• Catalan Government guidance, 3rd edition (October 2024), on requirements and conditions for advertising medical devices to the public.
• ORDRE SLT/144/2017 for Catalonia concerning public medical-device advertising.