Have you finished designing, developing, and manufacturing, and is your product ready to enter the market? When trading medical devices on the European market, obtaining the CE-mark is mandatory for every company or entity. With the CE-mark you declare that the medical device is in compliance with all legal requirements of the European market. The Medical Device Regulation (EU) 2017/745 is a set of requirements and processes for you as responsible party. When your medical device is in accordance with this set of requirements, the CE-mark can be affixed and the medical device can be legally introduced to the European market.

MEETING THE EU MEDICAL DEVICE REGULATIONS

As responsible entity you have to ensure that your medical device and its documentation meet the EU medical device directive. Where do you start? Every case is different and has its own unique characteristics. We have years of experience in medical product certification in the EU and internationally, and  offer swift and tailored certification of your medical device. Our consultants have complete knowledge of the EU’s medical device classification standards, so if you are unsure whether your product is classified as a medical device in Europe, we can confirm for you. With our certification process, we guarantee your medical device and documentation will meet all mandatory provisions. All we need is specific information of the medical device and we will arrange the rest.