{"id":7106,"date":"2019-07-22T14:38:13","date_gmt":"2019-07-22T14:38:13","guid":{"rendered":"https:\/\/arrotek.wpenginepowered.com\/eu-medical-device-classifications-explained\/"},"modified":"2024-10-11T13:04:40","modified_gmt":"2024-10-11T13:04:40","slug":"eu-medical-device-classifications-explained","status":"publish","type":"post","link":"https:\/\/arrotek.com\/en\/eu-medical-device-classifications-explained\/","title":{"rendered":"EU Medical Device Classifications Explained"},"content":{"rendered":"\n

Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. <\/p>\n\n

In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval. <\/p>\n\n

EU vs US Regulations<\/h2>\n\n

In the EU, new EU regulations, known as the new EU Medical Device Regulations, or MDR, are coming into force. One of the main changes in the new regulations involves different rules on the way medical devices are classified. <\/p>\n\n

If you have gone through the process of designing and developing a medical device before, you might find it different with the new EU MDR. For example, the medical device you want to develop might now fall into a higher classification. <\/p>\n\n

If you are going through the process for the first time, however, the changes in EU regulations will have less of an impact. One exception to this is the fact the new EU MDR brings the classification of medical devices in Europe more in line with international regulations. This includes FDA regulations which apply in the US. <\/p>\n\n

There are still some differences, particularly in relation to how you get regulatory approval in the EU compared to the US, but the closer alignment of the two systems has simplified many aspects.<\/p>\n\n

We\u2019ll look at the classification system in the US in more detail in a future blog. The focus here is on medical device classifications in the new EU MDR. <\/p>\n\n

EU MDR Medical Device Classifications<\/h2>\n\n

The classification system for medical devices under the new EU MDR is based on risk. The level of risk the medical device presents determines which classification it falls under. This classification then tells you: <\/p>\n\n