The standard products of ITD GmbH correspond to the MDR
The MDR, Regulation (EU) 2017/745 has been valid since 5th April 2017. The transitional period for the application of the MDD, Medical Devices Directive 93/42/EEC, ends on 26th May 2020, making the application of the MDR mandatory. Currently, there is already quite reliable information that - also due to the corona pandemic - the date could be postponed by one year.
At ITD GmbH, the work on the project "Introduction of MDR" was started on time.
The products of ITD GmbH will remain class I medical devices even after MDR. The assessment of conformity thus remains the sole responsibility of ITD GmbH, which acts as the manufacturer.
Possibly necessary technical modifications to the products of ITD have been checked and assessed as not necessary. Adjustments to the instructions for use and to the product and packaging labels were introduced in good time. The necessary additions to the technical documentation were also made.
Thus it was possible to ensure that the ITD standard products comply with MDR in good time. A corresponding CE declaration has been available since March this year.
ITD GmbH makes its contribution to ensuring that you, our customers, can bring systems based on our stationary and mobile device carriers that conform to the latest regulations to the market without interruption.
We will be pleased to assist you with specific questions.