
29.03.2022
CeCert on the way to MDR and IVDR
Last week we had the pleasure to participate as an exhibitor at International Trade Fair of Medical Equipment and...
We will contact you as soon as possible
05.01.2022
CeCert, as a notified body in the field of in vitro diagnostic medical devices, has recognized competences to evaluate and certify a wide range of devices for self-testing, including COVID-19 rapid tests. Our certificates are issued for a period of 5 years, however, due to the provisions of the Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 with regard to transitional provisions regarding certain in vitro diagnostic medical devices and deferred application of product requirements for personal use, this period will be shortened. As follows:
Devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid, may be placed on the market or put into service until 26 May 2025.
Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
If you have any questions, please contact us -> biuro@cecert.pl
Director of the Sales and Marketing Department
CeCert Sp z o. o.