Answers to CommonlyAsked Questions A third section, which only recently has come to our attention

Answers to CommonlyAsked Questions

A third section, which only recently has come to our attention, is the “Questions and Answers” page of the EU Commission website. Common questions include:

• Does a European database for Medical Devices exist?

• Is my product a medical device?

• What is a borderline product?

• Where can I find guidance and examples on borderline products, medical devices, and/or medicinal products?

• Where can I find information about harmonized standards under the Medical devices directives?

• Which process does a medical device have to follow to be placed on the market?

As a quick note regarding the first question, the explanation of Eudamed is provided as well as the disclaimer that access to the Eudamed database is limited to Competent Authorities only. The link to the MEDDEV guidance tables is provided here as well. In concert, links to the CEN/CENELEC (the European Committee for Electrotechnical Standardization), as well as to a list of published harmonized standards also are available.