CE marking, what it is and what it is not
Understanding the complex sector of medical device is becoming more and more difficult, both for the moment of transition between the directives on medical devices, active implantable medical devices and in vitro diagnostic medical devices, and the new and more specific regulations (2017/745/EU for medical devices and 2017/746/EU for in vitro diagnostic medical devices), and for non transparent behaviours often observed on the subject of obligations and requirements.
A rather thorny topic is CE marking, whose real nature is not always clear for manufacturers, importers and distributers, with consequent risk of underestimating its necessity and its importance.
But what is the CE marking? The most relevant data to be reminded is that it is a legal obligation: no device can be marketed without it. However, in frequent cases this is claimed as an additional property, intended to create a distinction from other devices, thus generating confusion among consumers.
The other important data is related to the device classification. In fact, the compliance with the obligation of the CE marking can be fulfilled by the manufacturer alone for class I devices only, that is for non active and non invasive devices presenting low risks. For these devices, the manufacturers should draft the required CE declaration of conformity, submitting a copy to the Ministry of Health and enclosing a series of technical documents.
Things change for class I sterile and measuring devices; for class IIa (medium risk) devices, such as non active and active devices interacting with the body without any danger; class IIb devices (medium/high risk), such as non active (especially invasive) and active devices interacting with the body with potential dangers; and class III (high risk) devices, such as implantable or drug-containing devices, devices with animal origin or those acting of vital organ functions.
The complexity of these devices does not allow the manufacturer to comply with the CE marking requirements independently. It is therefore necessary to use a Notified Body, i.e. a certification body designated by a Member State to assess the conformity of these devices. The Notified body is able to carry out all the testing required and to control the manufacturing system, then releasing a CE certification and monitoring the manufacturers during the period of validity of this certification, so that the manufacturer can continue to comply with their obligations. On the other hand, with the adoption of the new regulation, Notified Bodies are designated directly by the European Commission.
The CE certification issued by the Notified Body will be included in the technical dossier of the device to obtain the CE marking. Therefore, the Notified Body does simply take care of what the manufacturers cannot do when, in the case of more complex devices, the sole declaration of conformity would not be sufficient. Unfortunately, the general trend is to confuse CE certification and CE marking: in the reality of the directive, one is instrumental in obtaining the other.
Once the CE marking has been obtained, the manufacturer can apply it on the device and market it, keeping the relevant technical dossier available. This should be updated based on an appropriate procedure of conformity.
One last essential data is that the CE marking is possible only by subjects residing in the European Union. This implies, for extra-European manufacturers, the presence of a representative residing in the EU, a figure entrusted by the new Regulations with more tasks and greater responsibilities.
Finally, Brexit effects are not to be forgotten: the fate of British Notified Bodies and any compatibility between the CE marking and any similar certification by the United Kingdom are still to be defined.
