The EU’s Medical Device Regulation (MDR) is set to replace the current Medical Device Directive (MDD) for the regulation of medical devices. The MDR is an important development and will strengthen the current regulatory system for medical devices in Europe. It will become fully effective for new products/for significant changes to existing products and will fully apply to EU Member States from 26th May 2020. Changing from a directive to a regulation will ensure that the EU law is directly enforceable allowing for greater legal certainty and prevents variation on interpretation regarding medical devices that are available in EU member states.
Timesco considers the MDR to be a welcome development as the regulation places patient safety first. We have a team reviewing our product documentation in line with the revised requirements outlined in the MDR and we will continue to offer medical devices that are safe and reliable. We are ready to make any necessary changes to ensure that we remain compliant to the MDR and we anticipate to have completed this work by March 2020.
A copy of the Timesco MDR Statement is available for download by clicking on the image below and selecting the download button next to the full screen icon in the bottom right hand corner.
Please do not hesitate to contact us should you require any further information. T: +44 (0) 1268 297 700