Tag: medical devices


EU medical device regulation

For years, we have heard cases of faulty medical devices that have subjected patients to several risks. Most manufacturers have been put on the spot and even had their devices recalled or licenses canceled. Some have been forced to compensate affected patients with huge sums of cash. Regulatory bodies have, to a certain extent, played an essential role in ensuring devices have to go through a thorough procedure before they are declared suitable for use.

health device controlMedical Device Regulation (MDR) is a method used by manufacturers and the FDA to monitor several things involving medical devices. Developing a regulatory plan is one of the phases medical device manufacturers have to go through before launching their new product in the market. Post-market surveillance is done after the product is launched. It is all about monitoring the performance of these devices.

Companies should present their post-market surveillance plan before the product launch. You can make good use of the MDR Post Market Surveillance plan template to come up with a proper plan for your submission. Hiring a medical writer is vital through this process because they will convert the clinical data collected during the research stage into something that can be understood easily. Everything should be appropriate for submission. Regulations in the production of medical devices have proved to be beneficial in several ways which include:

Patient Protection

Medical device regulations have played an essential role in protecting patients from devices that can put their lives at risk. Cases of medical devices backfiring on patients and even leading to deaths are common in various parts of the world. This has reduced significantly because of the steps set by regulatory bodies to ensure everything produced is safe for human use. Devices meant for aesthetic purposes like implants are also included in this category.

Creation of Beneficial Devices

Companies that produce medical devices are required to make those that offer clinical benefits. Medical devices that provide no benefits have flooded the market before. Manufacturers are now required to list the benefits offered by the medical equipment they plan to introduce to the market in their submission.

Improved Post-Market Surveillance

medical device regulation

Post-market surveillance is essential in ensuring a particular medical device is working as required. Medical device regulatory bodies require manufacturers to give out their surveillance plan and different things they will do to monitor the performance of their medical devices. This is vital in keeping faulty products out of the market.…