MAP Europe has been extensively updated to reflect five new detailed guidance documents published in the last few days by the EU Commission on the Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The documents explain the changes that will occur as a result of the legislation, and contain recommendations on how companies can make sure they are complying with their new obligations in time for the provisions coming into effect.
The documents have been published in the context of a warning from MedTech Europe. The organisation had published a four page position paper calling for a delay of the implementation days of the regulations, citing insufficient progress in setting up essential infrastructure for the regulations’ application.
To read MAP’s updated analysis of the MDR and IVDR, along with advice for companies on how to ensure compliance with the new regulations, click here.