Continuation of CE-IVD products under IVDR
Continuation of CE-IVD products under IVDR

The In Vitro Diagnostics Regulation (IVDR) (EU) 2017/746 is the new EU regulatory framework and applies to all in vitro diagnostic medical devices placed on the EU market. The IVDR was introduced on May 25, 2017, ushering in a multi-year transition period for manufacturers and economic operators. It replaces the EU Regulation 98/79/EC on in vitro diagnostic medical devices (IVDD).
Therefore ,on the one hand medac GmbH will be certified as a distributor according to IVDR and also our manufacturers will adapt to the new regulation. For our own interest to continue our business activities, we are in close exchange with our suppliers in this regard.
In this context, we are pleased to inform you that all our suppliers are preparing for the implementation of the IVDR according to the information currently available to us and will certify their products at the latest by the end of the respective transition periods of the IVDR. According to the current situation, the deadlines are based on the future classification of the products (Class A, with the exception of sterile products until 26.05.2022; Class D until 26.05.2025; Class C until 26.05.2026; and Class B, as well as sterile products until 26.05.2027).
If you have any questions, please do not hesitate to contact us. We are looking forward to continuing to work with all of our customers, business and cooperation partners under IVDR conditions and to support you and your laboratory

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