Regulation (EU) 2017/745 on medical devices (MDR) is fully applicable since May 26, 2021. The MDR is considered a game changer for the medical device industry. The bad news is, that the new legal framework brings comprehensive changes in several aspects and increases hurdles for manufacturers and other economic operators before products may be placed on the market. The good news is, that mdi Europa can provide you with expertise and guidance for your transformation process.
The four major aspects that are affected by the MDR
1. Classification changes
The MDR has changed existing and introduced new classification rules for medical devices.
2. General safety and performance requirements
The MDR introduces a new set of requirements, which will replace the previous essential requirements. These will also include many points that have been referenced in guidance documents and standards under the medical devices directive (MDD).
3. UDI/ EUDAMED
The MDR introduces new traceability mechanisms including unique device identification (UDI) and comprehensive changes in the registration requirements for devices and economic operators.
4. Clinical evaluation
The requirements on the clinical evaluation process have been substantiated and further refined. This includes also a justification for the required level of sufficient clinical evidence and a defendable approach how the corresponding data will be generated.
But there is still more to learn in the new regulatory reality
We have guided nearly all of our clients already successfully through their transformation process and like to offer you our support.
Feel free to take a look at the different contributions which we are providing for you in our extensive website content regarding the MDR. If there are any specific areas of concern or interest above that, don’t hesitate and get in touch with us.
We also recommend the website of the European Commission as a valuable source of information for manufacturers of medical devices worldwide. Feel free to use the following image as a direct link.