Product listing
Product registration is a necessary step before placing the product on the EU market.
Manufacturer or Authorised Representative are obligated to notify the Competent Authority at least 14 days prior to placing the Medical Device (MD) or In Vitro Medical Device (IVD MD) on the market.
Competent Authority in Poland is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (PL: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych).
Process of the registration requires:
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Determining the device class
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Appointing an Authorised Representative and Notified Body (if required)
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Carrying the conformity assessment procedure and preparing the Declaration of Conformity
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Issuing Certificate of Conformity (if applicable)
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Placing CE marking as required
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Checking labels and instructions for use
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Preparing the documentation and application forms required for the registration
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Submit the documents to the Competent Authority
Placing the device on the market is done based on the Declaration of Conformity and Certificate of Conformity issued by Notified Bodies (if applicable), and does not require any special permits or approval from the Office. However the notification itself is obligatory.
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