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CILJ ISTRAŽIVANJA Cilj rada je sustavnim pregledom dostupne literature prikazati regulatorne aspekte nanotehnoloških medicinskih proizvoda za samotestiranje u Europskoj uniji. Detaljnije će biti opisani bitni regulatorni elementi u postupku odobravanja te subjekti i procesi u prometu nanotehnoloških medicinskih proizvoda za samotestiranje. U vidu nedavnih bitnih regulatornih promjena pažljivije će se razmatrati Direktiva 98/79/EC i Uredba 2017/746 o in vitro dijagnostičkim medicinskim proizvodima s naglaskom na bitne razlike. Nadalje, pružit će se uvid u utjecaj nanotehnologije na medicinske proizvode, nanomaterijale u nanotehnološkim medicinskim proizvodima za samotestiranje i primjenu takvih proizvoda. Predloženim istraživanjem će se nastojati uz pregled propisa koji prate proizvodnju, registraciju i promet nanotehnoloških medicinskih proizvoda za samotestiranje, dotaknuti i aktualni trendovi, akademske spoznaje i tržišni dosezi vezani uz iste proizvode. MATERIJAL I METODE Rad je pisan u obliku preglednog rada. Za potrebe istraživanja pretražena je domaća i strana literatura, propisi koji reguliraju promet medicinskih proizvoda i nanotehnologije u Europskoj uniji, mrežne stranice proizvođača nanotehnoloških medicinskih proizvoda te stranice radnih skupina i foruma vezanih uz temu istraživanja. Pretraživanje znanstvenih, stručnih i preglednih radova obavljeno je elektroničkim putem, pri čemu su pretražene bibliografske baze podataka (PubMed) i baze podataka s cjelovitim tekstom (Science Direct). Propisi i vodiči preuzeti su s mrežnih stranica Narodnih novina i Europske Komisije, Europske agencije za lijekove, Agencije za lijekove i medicinske proizvode (HALMED) i iz dostupnih radova. REZULTATI Svojstva nanomaterijala koji se koriste u medicinskim proizvodima opisana su Smjernicama za određivanje potencijalnih zdravstvenih učinaka nanomaterijala korištenih u medicinskim proizvodima (Znanstveni odbor za pojavu i identificiranje novih rizika, 2015.) što predstavlja i središnji dokument koji spaja područje nanotehnologije i medicinskih proizvoda. Direktiva 98/79/EC o in vitro dijagnostičkim medicinskim proizvodima koja je donedavno pratila promet medicinskih proizvoda za samotestiranje kao krovna uredba uspostavljena je prije tridesetak godina i nije značajnije mijenjana do Uredbe 2017/746. Spomenutom regulativom se nastoji održati nesmetan promet proizvoda na jedinstvenom tržištu zemalja članica Europske Unije uz visoke standarde kvalitete, sigurnosti i učinkovitosti medicinskih proizvoda zbog zaštite zdravlja pacijenata, a u skladu s namjenom proizvoda. S ciljem stavljanja na tržište nanotehnološkog medicinskog proizvoda za samotestiranje potrebno je zadovoljavati bitne zahtjeve i proći odgovarajući postupak ocjene sukladnosti. Proizvođač je nositelj pravne odgovornosti za medicinske proizvode za samotestiranje u svim aspektima i propisuje mu se kao obaveza imati cjelovit sustav upravljanja kvalitetom. ZAKLJUČAK Medicinski proizvodi za samotestiranje važni su u dijagnostici i kontroli bolesti te se uslijed dostupnosti i razvoja novih tehnologija i trendova personalizirane medicine na tržištu opravdano očekuje porast broja nanotehnoloških medicinskih proizvoda za samotestiranje. Za područje nanomedicine ne postoji jedinstven skup propisa. Proizvođač kao odgovorna osoba mora biti u tijeku s najnovijim spoznajama u tehnologiji i promjenama u medicinskoj praksi i regulativi kako bi plasirao nanotehnološki medicinski proizvod na tržište i nesmetano ga držao u prometu. Uredba 2017/746 o in vitro dijagnostičkim medicinskim proizvodima predstavlja prijelomnu i dugo očekivanu promjenu u regulativi, krovna je uredba koja prati promet nanotehnoloških medicinskih proizvoda za samotestiranje i u središte stavlja sigurnost i učinkovitost medicinskih proizvoda za samotestiranje, sljedivost i transparentnost, kliničke dokaze i obavezan sustav vigilancije. Specifičnosti u regulativi medicinskih proizvoda za samotestiranje ponajviše se vežu uz razvrstavanje u klasu rizika, ocjenu sukladnosti, kliničke dokaze i prepoznavanje uloge krajnjih korisnika u procesu dijagnostike. OBJECTIVE The aim of this study is to systematically review the regulatory aspects of nanotechnological medical devices for self-testing in the European Union by a systematic review of available literature. The essential regulatory elements in the approval process and the subjects and processes in the marketing of nanotechnological medical devices for self-testing will be described in detail. The parallels between Directive 98/79/EC and Regulation 2017/746 on in vitro diagnostic medical devices will be particulary analyzed in view of the recent regulatory changes. The study will also explore the impact of nanotechnology on medical devices, nanomaterials used in medical devices for self-testing and the application of nanotechnological medical devices for self-testing. The proposed research will seek to review the related trends, academic achievements and commercial reaches along with the review of the regulations that accompany the production, registration and marketing of nanotechnological medical devices for self-testing. MATERIAL AND METHODS This paper presents a review paper. For the purpose of the research domestic and foreign literature, regulations regulating the field of medical devices and nanotechnology in the European Union, web pages of manufacturers of nanotechnological medical devices and working groups and forums related to the topic were reviewed. Original scientific and review articles were searched electronically using bibliographic database (PubMed) and full text database (Science Direct). Regulations and guides were downloaded from the web pages of the Official Gazette of Republic of Croatia (Narodne novine) and the European Commission, European Medicines Agency (EMA) and the Croatian Agency for Medicinal Products and Medical Devices (HALMED) websites. RESULTS The properties of nanomaterials used in medical devices are described in the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices (Scientific Committee on Emerging and Newly Identified Risks – SCENIR, 2015) which also presents a central document that merges the fields of nanotechnology and medical devices. Directive 98/79/EC on in vitro diagnostic medical devices, which until recently monitored marketing of medical devices for self-testing, was established some thirty years ago and was not substantially changed until Regulation 2017/746 although change was greatly needed. New regulation seeks to keep the uninterrupted single market of EU member states and high standards of quality, safety and efficacy of medical devices for the protection of patients' health. In order for nanotechnological medical devices for self-testing to be placed on the market, they must meet the essential requirements and pass an appropriate conformity assessment procedure. The manufacturer is responsible for all aspects of medical devices for self-testing and is credited as having the obligation to have a complete quality management system. CONCLUSION Medical devices for self-testing present important tools for diagnostic and control of diseases, and because of the availability and development of new technologies and trends of personalized medicine we can expect an increase of the number of nanotechnological medical devices for self-testing on the market. There is no single set of regulations for nanomedicine. The manufacturer as the responsible subject must keep up with the latest achievments in technology and changes in medical practice and regulations to successfully market nanotechnological medical devices for self-testing. Regulation 2017/745 on in vitro diagnostic medical devices presents a breaking and long-awaited change in the regulations, focuses on the safety and efficacy of medical devices for self-testing, traceability and transparency, clinical evidence and a mandatory vigilance system. Specifics in the regulation of medical devices for self-testing are mostly linked to risk classification, conformity assessment procedure, clinical evidence and the role of lay people in the self-testing process. |
