Vademecum Początkującego Wytwórcy



Przygotowując się do pierwszej certyfikacji, jako wytwórca wyrobu medycznego możesz mieć wiele pytań i wątpliwości. Rynek wyrobów medycznych jest bardzo obszerny, a same wyroby dzielą się na klasy w zależności od ryzyka związanego z ich stosowaniem oraz grupy oznaczające ich dedykowane przeznaczenie. Nic więc dziwnego, że początkowo lista wymogów do spełniania wydaje się nie mieć końca, a gęstwina przepisów i aktów prawnych, trudna do przebrnięcia.
W tym miejscu postaramy się udzielić Ci kilku rad, na temat którą ścieżką podążać by dotrzeć do celu, jakim jest wprowadzenie wyrobu medycznego na rynek.


 


Na początku warto zebrać  obowiązujące akty prawne, które określają konkretne wytyczne m.in. jakie obowiązki spoczywają na wytwórcy, jak dokonać klasyfikacji wyrobu, jak przygotować ocenę zgodności itp. Tu z pewnością najpotrzebniejsze dokumenty to:
    - Dyrektywa 93/42 EEC
    - Ustawa o wyrobach medycznych
    Pamiętaj też, o istnieniu norm zharmonizowanych z dyrektywą. To one określają w jaki sposób należy spełnić  wymagania dotyczące elementów systemu zarządzania jakością , analizy ryzyka czy bezpieczeństwa elektrycznego wyrobów. Zajrzyj zatem na listę norm zharmonizowanych. Normy, które na pewno okażą się niezbędne to:



    - PN-EN ISO13485:2012
    - PN-EN ISO14971:2012
       
    Dodatkowo, w zależności od tego jakiego rodzaju wyrób medyczny produkujesz , pomocne okazać się mogą m.in.:
      - Trzecia edycja normy IEC 60601-1, która dotyczy bezpieczeństwa elektrycznego
      - PN-EN ISO10993-1 traktująca o ocenie biologicznej wyrobu medycznego






      Jeśli twój wyrób medyczny posiada klasę wyższą niż Kl. I, konieczne będzie zwrócenie się do jednostki notyfikowanej, która dokona oceny zgodności. Jeśli wspomniana ocena zrealizowana podczas auditu w twojej firmie przebiegnie korzystnie, jednostka wyda stosowny certyfikat. Co roku będzie też sprawdzać, czy jakość wyrobu jest na stałym wysokim poziomie, oraz czy procesy związane z wytwarzaniem wyrobu zapewniają wspomniana jakość.







      Przygotowując się do auditu powinieneś przygotować dokumentację techniczną wyrobu czyli:
      • dokument klasyfikacji wyrobu
      • listę kontrolną wymagań zasadniczych
      • schemat blokowy i krótki opis działania wyrobu (jeśli twój wyrób zawiera oprogramowanie, lub jest oprogramowaniem)
      • zarządzanie ryzykiem
      • dokument „przewidziane zastosowanie”
      • ocena kliniczna (literaturowa)
      • raport biokompatybilności (jeżeli dotyczy)
      • raport bezpieczeństwa elektrycznego (wyniki badań wg. Normy EN 60601-1)*
      • raport kompatybilności elektromagnetycznej (wyniki badań wg. EN 60601-1-2)*
      • raport walidacji oprogramowania (jeżeli wyrób zwiera oprogramowanie)
      •  raport walidacji procesu sterylizacji (jeśli twój wyrób jest sterylny)
      •  instrukcja użytkowania
      • oznaczenia wyrobu (np. tabliczka znamionowa)
      • raport badania funkcji pomiarowych (jeżeli wyrób spełnia definicję wyrobu medycznego z funkcja pomiarową).
      * jeśli jest to elektryczny wyrób medyczny



      Zdajemy sobie sprawę, że samodzielne przygotowanie się do pierwszej certyfikacji może nie być łatwe. Dlatego też posiadamy najszerszą na polskim rynku ofertę szkoleniową dla wytwórców wyrobów medycznych.
      Na naszych szkoleniach otwartych chętnie dzielimy się wiedzą, jak poruszać się po przepisach prawnych, oraz jak w praktyce realizować ich wymagania.
      Nasze szkolenia przybierają różne formy. Korzystając z zalet takich metod jak seminarium, studium przypadku czy warsztat, dbamy o to, by przekazana wiedza utrwaliła się w pamięci uczestników i by łatwo można ją było wydobyć celem przekucia teorii w praktykę.



      Nie prowadzimy indywidualnych konsultacji, ani nie wdrażamy systemu zarządzania jakością.  Naszą wiedzą i wparciem dzielimy się otwarcie i wszystkich (zarówno obecnych jak i potencjalnych klientów) traktujemy równo.
      Jeśli masz pytania dotyczące procedur certyfikacji, wymaganych dokumentów, lub po prostu zagubiłeś się gdzieś po drodze, zadzwoń i zapytaj. Chętnie pomożemy, ale nie wykonamy pracy za ciebie.

       







       Jeśli wykonasz swoją pracę rzetelnie, a twój wyrób zostanie oceniony jako bezpieczny, otrzymasz certyfikat potwierdzający spełnienie wymagań zasadniczych dyrektywy. Teraz możesz zgłosić swój wyrób do Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych. Po 14 dniach od zgłoszenia możesz wprowadzać swój wyrób na rynek UE.







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