05.01.2022 /ivd /ivdr /2017/746 /98/79/EC

Validity of the CE IVD certificates

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Validity of the CE IVD certificates

 

Validity of the CE IVD certificates

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:

  1. 26 May 2025 for class D devices;
  2. 26 May 2026 for class C devices;
  3. 26 May 2027 for class B devices;
  4. 26 May 2027 for class A devices placed on the market in sterile condition.

If you have any questions, please contact us -> biuro@cecert.pl

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