Obtaining the CE Mark for PacePress® Fast

February 24, 2025

Medinice S.A. received notification from the notified body TÜV Nord Polska on the positive completion of the conformity assessment and compliance evaluation process – based on the comparator – for the medical device PacePress®, known as PacePress Fast.

This is the first CE mark in the company’s history and a key achievement that officially confirms that the medical device developed by Medinice meets the highest EU standards of quality and safety. Obtaining the CE marking opens up new opportunities for Medinice in the medical market, increasing the trust of business partners and facilitating the submission of the product to relevant regulatory authorities in countries outside the European Union, such as the United Kingdom, Canada, Switzerland, India, and Australia.