Title Regulatorni aspekti nanotehnoloških medicinskih proizvoda za samotestiranje Author Ivana Ivanušić Capak Mentor Ivan Pepić (mentor)Committee member Jasmina Lovrić (predsjednik povjerenstva)Committee member Ivan Pepić (član povjerenstva)Committee member Ivica Malnar (član povjerenstva)Granter University of Zagreb Defense date and country 2018-09-26, Croatia Scientific / art field, BIOMEDICINE AND HEALTHCARE Abstract 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.
Abstract (english) 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.
Keywords
nanotehnološki medicinski proizvodi za samotestiranje
nanotehnologija
nanomaterijali
Keywords (english)
nanotechnological medical devices for self-testing
nanotechnology
nanomaterials
Language croatian URN:NBN urn:nbn:hr:163:057927 Study programme Title: Drug development Type of resource Text File origin Born digital Access conditions Open access Terms of use Created on 2019-03-13 14:58:46
