EU MDR's 12 Month Reprieve
Due to Covid-19, on 17th April 2020, the European Parliament gave Medical Device companies a 12-month reprieve on EU MDR (European Medical Device Regulations), allowing them time to get their houses in order.
The regulation, which commenced in May 2017, imposes rules on companies involved in the design, manufacture, approval and commercialization of devices that are sold in the EU.
The first major milestone is now confirmed for May 26th 2021, with full application of EU MDR, followed by EU Database for Medical Devices (EUDAMED) officially going live a year later (May 26th 2022). Its impending enforcement presents numerous labeling challenges that could ultimately prevent organizations from being able to sell their products in Europe if they are not addressed.
Read this whitepaper to find out how you can simplify the path to compliance.