Ukrainian Scientific Institute of Certification

Batch verification

13/08/2018

The procedure of conformity assessment through examination of medical device batch involves issuing a certificate for a particular batch of products (lot), or for a medical device with a certain serial number. In this case, it is necessary to review the documentation and examine the products in an accredited testing laboratory. This procedure is suitable for large, expensive equipment, for infrequently used products, for fast product’s placing on the market or in the case of a manufacturer’s refusal to grant access for audit of production sites.

The procedure of conformity assessment through examination of medical device batch does not involve audit of production and therefore is not applied when assessing the conformity of sterile products!

This procedure can be used for:

To obtain certificate for the batch of devices you need:

  • Appoint Authorized representative of manufacturer on the territory of Ukraine, perform all legal formalities associated with this;
  • Draw up a Technical file in accordance with the requirements of the relevant regulations and related legislation;
  • Submit an Application and an accompanying dossier of documentation for the procedure to the designated conformity assessment body;
  • Complete the procedure of examination of documentation as well as examination of the products in an accredited testing laboratory;
  • Obtain a certificate of conformity to Technical regulations requirements for medical device batch or medical device with a certain serial number;
  • Draw up Declaration of conformity to Technical regulation requirements;
  • Affix conformity mark and identification number of conformity assessment body on the label and instruction for use of medical device.

The Ukrainian Scientific Institute of Certification conducts the conformity assessment procedure through examination of medical device batch, relying solely on the obtained objective evidence and being completely independent and impartial in its decisions, fulfilling all aspects of Ukrainian legislation and guided by EU legislation. We carry out expert examination of documents in English, German, Ukrainian and Russian.

In order to receive individual information, you can contact us by phone at +38 (044) 227-41-46 or write to office@uni-cert.ua

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