You will be aware from previous posts that industry has been concerned for some time about the amount of work to be done to ensure compliance with the Medical Devices Regulation (MDR), and whether this can be completed by May 2020, the date of application of the Regulation. However, so far, the Commission’s response has been that the current deadline is “realistic and achievable” and that there were no plans to delay implementation.
This week, as an early Christmas present to industry, while there is no delay to the data of application of the MDR, there is some good news: a “corrigendum”, or correction, to the MDR, has been approved by the Parliament that adds certain Class I devices to those devices that benefit from the transitional period under the MDR. This will give manufacturers of certain Class I devices additional time to comply with the Regulations.
Continue Reading Delays to the EU Medical Devices Regulations