If you have never done it before, the medical device CE marking process can be confusing, difficult to understand, and time-consuming. It will be costly if not handled properly.
The European Medical Device Regulation outlines safety and performance requirements for medical devices sold within the European Economic Area (EEA).
The CE marking symbolises that the manufacturer has met the Directive’s requirements and can legally sell in all EU countries.
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Some medical device manufacturers will say that obtaining a CE marking is too complicated, expensive, and time-consuming. That’s not true when you partner with the experts in the Compliance Team at Zatisfy. We have the experience to reduce the time it takes and the stress of the process. We have the network to manage the entire process, from initial classification to the final CE certification.
Although there have been recent changes to CE marking for medical devices, the basic process remains the same with the Medical Device Regulation (MDR). The initial step is to classify your device correctly. The other steps include identifying European Harmonised Standards, technical documentation, appointing a European Authorised Representative, certification, and affixing the CE mark.
If you build a prototype medical device that you plan to sell in the EU, contact us first. We can advise you on the documentation, testing, and design aspects that may save you from costly compliance redesign issues down the road. Zatisfy with partners offers more than 30 years of experience certifying medical devices and an extensive network of specialists to advise you.
The CE certification process is complex and lengthy. We have the team and systems to organise and expedite your device’s path through the confirmation process. We ensure that your medical device meets every regulation and testing requirement. Our goal is to see that your product enters the EU market legally as quickly as possible.
The CE mark may not be the last hurdle to selling your medical device. There may be additional national requirements with which it must comply. Countries such as France, Greece, Italy, and Portugal require other authorisation. Zatisfy can help you with all the steps in the process, no matter in which countries you plan to do business.