Medical Devices Regulation (EU) 2017/745 is the assessment procedure that all medical products go through before they can legally enter the European market. Just like any other product that wants to enter the product market, medical products need to adhere to laws concerning the safety of their production process. Because Medical Devices encompass many different products with a wide variety of functions and thus risks, the products cannot be assessed with one and the same procedure. Therefore, the products are divided into categories, ranging from low risk (Class I) up to high risk (Class III). The conformity assessment is then dependent on the class that the product belongs to. This way, it is made certain that each product is in line with the appropriate European legislation.

This legislation is enforced by the national authorities of EU countries. They are obliged to follow specific procedures that have been established as The Medical Devices Directives.

These procedures entail:

  1. Assessing whether a medical device is safe and thereby suitable for the market.
  2. Assessing whether the CE marking is rightfully and correctly affixed or not.

Only if the product is considered safe and carries the CE mark, can it enter the EU product market. We can help you to find the right assessment procedure and obtain the correct marking.

If you want to know more about CE marking, visit our knowledgebase and go to “CE Marking”.