Medical devices have to bear a CE mark. This hold true also for toys and elevators and many other product classes.
What does this CE mark stand for? Is there something like a "CE certification" for medical products or other devices? This article gives answers.
Originally CE stood for Communauté Européenne (European Community) later for Conformité Européenne. With the CE mark a manufacturer expresses conformity with the European legislation, specifically with European directives and European regulations.
For of medical devices there are (or have been) the Medical Device Directive MDD, the Active Implantable Medical Device Directive AIMDD and the In-vitro Device Directive IVDD.
These directives are going to be replaced by the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR. The manufacturers still declare conformity and affix the CE mark (sometimes also referred to as "CE label") themselves.
The first precondition that a manufacturer affixes the CE mark is that the medical device fulfills the "essential requirements" as laid out in Annex I of MDD, respectively the "general safety and performance requirements" as laid out in Annex I of MDR.
Read here more about the essential requirements and how to prove compliance.
The second precondition is that the manufacturer performs a conformity assessment procedure. There a multiple procedures the manufacturers can pick depending on the risk class.
For class I devices the manufacturer does not have to involve any external party such as a notified body. In this case they affixes the CE mark with no number.
For all the other classes it is mandatory to involve a notified body. The CE mark must bear the notified body's number.
Read more about conformity assessment procedures.
There is no CE Certification. There is no agency like the FDA or the European Medicine Agency approving or certifying medical devices.
However, there are other types of certificates issued by the notified bodies:
There is not a CE certification or CE certificate, this term is commonly used for medical devices that successfully passed the conformity assessment procedure and that are legally labeled with a CE mark.
There is not much of a difference in the European and FDA approval processes since the latest switch from the European directives to the European regulations.
In Europe manufacturers are not quite in such weak positions as in the US. The outcome of both approaches in terms of incidents and patient safety are about the same, the overhead and unpredictability of the process used to be higher in the US.
The Johner Institute has a team specialized in providing support for manufacturers of medical devices that contain software or that are standalone software.
Our team can help: