After affixing the CE-Mark to a device, the manufacturer still needs to comply with European post-market requirements. This means that you as the manufacturer should be prepared for possible questions and/or inspections from national authorities.

The main issues of concern during the post-market phase include:

LABELING

With over 20 different languages, the issue of labeling and language has become very complex in the European market.

We can help you sort through the various language requirements and maintain your device labeling compliance in the diverse European market.

VIGILANCE

The manufacturer must notify the competent authorities of any incidents involving products in use that have or could have seriously compromised the patient’s or user’s health.

We can help you with the decision of whether the event needs to be reported. Furthermore, if a report is needed, we will help you prepare it and submit it to the appropriate authorities.

REGISTRATION: BEYOND THE CE-MARK

While the CE-Mark holds the key to marketing in Europe, it does not open the door completely. More and more countries now require additional information from companies manufacturing devices already holding the CE-Mark. Depending on the country, this information can be the simple act of registering a product, but it can also be a much more complex procedure almost similar to the actual CE-Mark process.

Push-Med can help you with the tedious process of figuring out each countries different requirements and the actual registration/submission to the national authorities.