Rozpoczęliśmy proces uzyskania statusu jednostki notyfikowanej w zakresie Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 z dnia 5 kwietnia 2017 r. w sprawie wyrobów medycznych.
Zapraszamy do kontaktu i współpracy.
Rozpoczęliśmy proces uzyskania statusu jednostki notyfikowanej w zakresie Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 z dnia 5 kwietnia 2017 r. w sprawie wyrobów medycznych.
Zapraszamy do kontaktu i współpracy.
Dear Sirs,
ICR Polska informs that:
– since 26th March, ICR Polska stopped accepting new certification inquiries in scope of covid-19 related products,
– all certificates issued by ICR Polska within the scope of covid-19 related products are voluntary basis
– voluntary certificates are not required by any legal act and are not equal to conformity assessment procedures restricted for notified bodies in that scope
– voluntary certificate is not obligatory to import goods to EU market
– voluntary certificate does not entitle manufacturer to affix CE mark on its product
– CE mark is designed to be placed on the product according to EU relevant regulation after fulfilling product applicable essential requirements
– all issued certificates in period of 1st – 26th March 2020 in scope of products related to Covid-19 has been withdrawn and ICR Polska is processing their re-issue on new certificate template and new identification numbers
– ICR Polska decided to conduct process of withdrawn and re-issue due to number of invalid or fake certificates and to make full clarification to certificate user about its condition and scope by re-editing its content
– from March 26th, following stamp are no longer in use in ICR Polska certificates
– status of certificate can be check: https://cert.icrpolska.com
online database is in its developmental stage, hence it may miss information and not does not contain all data about certificate requires for identification.
ICR Polska upgrades database on regular basis, yet certificate validity can be also confirmed through: icrpolska@icrqa.com
– ICR Polska has upload valid voluntary certificate template and examples of invalid certificates, that pretend to be issue by ICR Polska:
https://icrpolska.com/dokumenty-publiczne/
– certificates issued according to test report provided by China supplier Shanghai MICEZ Equipment Testing & Technical Co., Ltd. has not been re-issued and remains invalid or fake
– ICR Polska upload all certificates recognized as fake or invalid to online database
26-03-2020
W związku ze wzmożonym zainteresowaniem uzyskaniem certyfikatu na zgodność z normami zharmonizowanymi z rozporządzeniem Komisji Europejskiej dot. środków ochrony indywidualnej o nr 2016/425, informujemy, że ICR Polska Sp. z o.o. nie przyjmuje więcej wniosków o udzielenie certyfikacji w powyższym zakresie.
Jednocześnie wyjaśniamy, że zgodnie z treścią wydawanych certyfikatów przeprowadzone dotychczas oceny mają charakter dobrowolny i nie są równoznaczne z obowiązkowymi procedurami oceny zgodności prowadzonymi przez uprawnione do w/w rozporządzenia Jednostki Notyfikowane. Certyfikaty te nie potwierdzają zgodności z wszystkim wymaganiami zasadniczymi Rozporządzenia 2016/425 odnoszącymi się do wyrobu.
Due to the increased interest in obtaining a certificate of compliance with the standards harmonized with the European Commission Regulation on personal protective equipment No. 2016/425, we would like to inform that ICR Polska Co, Ltd. no longer accepts applications for certification on this scope.
At the same time, we explain that, in accordance with the content of issued certificates, the assessments carried out so far are of a voluntary nature and are not equivalent to the mandatory conformity assessment procedures carried out by Notified Bodies authorized to the aforementioned Regulation. These certificates do not confirm conformity with all essential requirements of Regulation No. 2016/425 relating to the product.