Placing the product and make it available on the EU market requires meeting many requirements. Each medical device has to be CE marked and then notified/submitted.
We offer:- Identification of applicable legal requirements, ISO/AAMI standards, guidelines, FDA, and their implementation
- Review/checking of documentation required for notification, Declaration of Conformity, CE marking
- Risk Analysis
- Review/verification of Technical File that meets the requirements of MDD 93/42 / EEC - Medical Devices Directive, Polish Medical Devices Act of 20 May 2010 - including specific product requirements and compliance with the requirements of harmonized standards (i.a. Evaluation storage conditions, shelf-life tests, biocompatibility, transport tests)
- Review/checking of labeling – according to law requirements and ISO standards (leaflets, IFU –instruction for use, labels, marketing brochures, pictograms and other
- Help with proper classification of medical device, help in issuing the Declaration of Conformity
- Help in carrying out (according to the product class) conformity assessment procedures, verification of the fulfillment of the Essential Requirements
- Help in selecting and preparing the documentation for the selected notification body (product certification)
- Product submission/notification to URPLWMiPB
Attention: On Friday, 5th of May 2017 there was new European regulation issued – MDR. Here you can find information about MDR.