Showing posts tagged with: CE Mark

When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the EU market is done differently. What you need to know to apply for approval or notification will be explained here below. For better understanding, you have to know...

Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic terms in the medical device industry: Medical device manufacturers, as well as other companies involved in the distribution of devices, must follow certain requirements and regulations once devices are...

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR). There are few ways to do so, and it’s known as conformity assessment routes. We...

CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know about the CE mark. In case you are MedDev Start-up, planning to...

  Traceability is required by regulations. Traceability Matrix Updated 2019, For FDA, 510(k), DeNovo or PMA, traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met. For the CE mark, the requirements are similar, if not the same! Failure to...