Pregled regulatornih zahteva u SAD, EU i Srbiji za softver – mobilnu aplikaciju kao medicinsko sredstvo – pregled najnovijih saznanja
Sažetak
Broj mobilnih aplikacija namenjenih za zaštitu zdravlja i dobrobiti pacijenata/korisnika je u stalnom porastu. Cilj ovog preglednog rada bio je uporedna analiza propisa za softvere – mobilne aplikacije kao medicinska sredstva u Sjedinjenim Američkim Državama (SAD), Evropskoj uniji (EU) i Srbiji, sa osvrtom na napore za međunarodno usaglašavanje propisa. Namera je da se poveća upoznatost većeg broja zdravstvenih radnika o ovoj temi. Analizirane su i sintetizovane javno dostupne informacije sa sajtova zvaničnih regulatornih tela za dva regiona i jednu zemlju od interesa. Rezultati pokazuju razlike u regulatornim pristupima u ovoj oblasti između dva najveća tržišta medicinskih sredstava - SAD i EU, dok se regulativa u Srbiji usklađuje sa EU. Pregledani propisi jasno definišu kriterijume koje softveri – mobilne aplikacije moraju da zadovolje da bi se procenjivali kao medicinska sredstva; sa druge strane, oni ostavljaju jedan broj aplikacija koje pružaju usluge u oblasti zaštite zdravlja i/ili dobrobiti pacijenata/korisnika izvan regulisanog opsega. Na osnovu bolje upoznatosti sa regulativom, dalja istraživanja se mogu usmeriti ka nalaženju načina za većim angažovanjem zdravstvenih radnika u savetovanju pacijenata i donošenju odluka oko izbora mobilnih aplikacija, kako bi sprečili upotrebu neadekvatnih mobilnih aplikacija i osigurali da njihovi pacijenti pravilno koriste prave aplikacije sa pozitivnim efektima na njihovo zdravlje i blagostanje.
Reference
About IMDRF [Internet]. International Medical Device Regulators Forum (IMDRF); c2022 [cited 2022 Feb 11]. Available from: http://www.imdrf.org/about/about.asp
International Medical Device Regulators Forum. IMDRF SaMD Working Group. Software as a Medical Device (SaMD): Key Definitions. IMDRF, 2013.
Status of the Global Medical Device Market [Internet]. Korea Health Industry Development Institute; c2022 [cited 2022 Feb 11]. Available from:
Part II: 1938, Food, Drug, Cosmetic Act [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-ii-1938-food-drug-cosmetic-act
Part III: Drugs and Foods Under the 1938 Act and Its Amendments [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-iv-regulating-cosmetics-devices-and-veterinary-medicine-after-1938
Milestones in U.S. Food and Drug Law History [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history
21st Century Cures Act [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
FD&C Act Reference Information [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
United States Code: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399.
United States Code: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360j (o).
United States Code: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360c.
How to Determine if Your Product is a Medical Device [Internet]. U.S. Food & Drug Administration; c2022 [cited 2022 Feb 11]. Available from: https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device#step1
U.S. Food & Drug Administration. Policy for Device Software Functions and Mobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff. U.S. Food & Drug Administration, 2019.
Medica Device Sector, New Regulations [Internet]. European Commission; c2022 [cited 2022 Feb 11]. Available from: https://ec.europa.eu/health/medical-devices-sector/new-regulations_en
Directive 90/385/EEC. Official Journal of the European Communities, L 189, 20.7.1990, p.17.
Directive 93/42/EEC. Official Journal of the European Communities, L 169, 12.7.1993, p. 1.
Directive 98/79/EC. Official Journal of the European Communities, L 331, 7.12.1998, p. 1.
Regulation (EU) 2017/745. Official Journal of the European Communities, L 117 5.5.2017, p. 1.
Regulation (EU) 2017/746. Official Journal of the European Communities, L 117 5.5.2017, p. 176.
Regulation (EU) 2020/561. Official Journal of the European Communities, L 130, 24.4.2020, p. 18–22.
Regulation (EU) 2022/112. Official Journal of the European Communities, L 19, 28.1.2022, p. 3–6.
European Commission. Medical Devices: Guidance document - Qualification and Classification of standalone software. EC, MEDDEV 2.1/6, 2016.
European Commission, Working group on borderline and classification. Manual on borderline and classification in the community regulatory framework for medical devices. EC, Version 1.22, 2019.
Medical Device Coordination Group Document. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. MDCG 2019-11
MHRA, Guidance: Medical device stand-alone software including apps (including IVDMDs), v1.08, 2021.
Law on medical devices. Official Gazette of the RS, No. 105/2017.
Rulebook on essential requirements for medical devices. Official Gazette of the RS, No. 65/2018.
Medical Devices Registry [Internet]. Medicines and Medical Devices Agency of Serbia; [cited 2022 Feb 11]. Available from: https://ms.alims.gov.rs/pages/view-registarmedicinskihsredstava
- Autori zadržavaju autorska prava i pružaju časopisu pravo prvog objavljivanja rada i licenciraju ga "Creative Commons Attribution licencom" koja omogućava drugima da dele rad, uz uslov navođenja autorstva i izvornog objavljivanja u ovom časopisu.
- Autori mogu izraditi zasebne, ugovorne aranžmane za neekskluzivnu distribuciju članka objavljenog u časopisu (npr. postavljanje u institucionalni repozitorijum ili objavljivanje u knjizi), uz navođenje da je članak izvorno objavljen u ovom časopisu.
- Autorima je dozvoljeno i podstiču se da postave objavljeni članak onlajn (npr. u institucionalni repozitorijum ili na svoju internet stranicu) pre ili tokom postupka prijave rukopisa, s obzirom da takav postupak može voditi produktivnoj razmeni ideja i ranijoj i većoj citiranosti objavljenog članka (Vidi Efekti otvorenog pristupa).