The medical Device Regulation increased focus on post-market surveillance and clinical evidence. Manufacturers of medical devices are now required to increase their focus regarding gathering safety-related data and clinical data. For the manufacturer, the requirements affect the costs of research and development as well as market access. The importance of PMS, however, outweighs the strain on operations that the manufacturers experience. Some of the top reasons why manufacturers rely on the EU MDR Post Market Surveillance plan template devices are highlighted below.
To Maintain High Medical Standards
In the past, there have been cases of manufacturers selling medical devices and equipment that are not of pharmaceutical grade. Such create quite a scare in the health industry and poses numerous risks to end-users. Post-market surveillance helps to curb that. It does so by ensuring that the medical devices reach the end-users and are utilized while still in acceptable condition, through all the stages of transportation, storage, cleaning, and others.
To Improve the Approval Process
Many medical devices have been approved to enter the market without having illustrated long-term safety or clinical efficacy. Such are usually approved for the market based on equivalence to other devices that were marketed legally. Using equivalence is not an ideal way to approve medical devices, especially when you consider how long ago the original approvals were issued. Post-market surveillance helps to ensure that those products deliver on both safety and clinical efficacy all the way.
To Improve Quality of Medical Products
Using strict clinical trial requirements as opposed to equivalence is one of the ways that the quality of medical devices produced can be improved. However, since the equivalence rule still applies, post-market surveillance has to come into play. It can work as a tool that helps to filter the faulty medical devices out of the market, leaving only the ones that are safe and effective.
It Provides Useful Information
By manufacturers increasing focus on post-market surveillance, they can collect a lot more data and information that is related to their devices. The data and information collected can be quite useful regarding improving the safety, clinical efficacy, and quality of their products. Researchers get a lot more relevant information to work with and can come up with better solutions to existing problems in the medical field.
Increased post-market surveillance does cost the companies more, but when the data and information received is utilized well, it can have attractive returns.…