To sell medical equipment in the EU (European Union), you must apply or obtain CE marking for your device. CE marking indicates that your medical equipment complies with the applicable EU regulations, is fit for its purpose and won’t endanger lives.
Fortunately, getting your CE mark medical device is not as difficult, costly, or complicated as most people think with knowledgeable guidance and understanding. In this blog, we’ll walk you through some of the critical steps in getting your CE mark medical device.
Steps to follow to get the CE mark medical device
To get a CE mark medical device, you must first identify what EU directives are applicable to your device. The next step is to gather evidence that the device complies with the applicable directives. After that, establish a QMS (Quality Management System) to manage your medical device and then produce a technical file to satisfy EU (Medical Device Regulation (MDR) essential requirements.
Now you will need to have your documentation and QMS audited by a notified body. Once you have passed your audit, it is time to be issued a CE marking certification for your equipment along with an ISO 13485 certificate, which establishes that your QMS is compliant with European standards. Lastly, prepare a DoC (Declaration of Conformity) that usually states that your equipment complies with the appropriate Directive.
The bottom line
Ensuring that your equipment meets compliance standards is vital for the safety of consumers. As a manufacturer, it’s your responsibility to make sure that your medical device meets EU safety needs before putting it on the market. So whether you involve a third party or go about it alone is your decision.
Certification, however, is complex and time-intensive. And working with experts in the fields saves energy and time.