In order to be placed on the European Market, a medical device (MD) shall comply with one of the relevant European regulations (Directive 93/42/EEC and Regulation EU 2017/745), while a personal protective equipment (PPE) shall comply with the Regulation 2016/425.
The compliance with the relevant regulation is demonstrated by the CE certification that can only be issued by a designated Notified Body following the conformity assessment.
Moreover, only the Notified Bodies authorized at European Union level can issue CE certificates with a legal validity on the European Union territory.
The identification code of the Notified Body shall be reported on both the CE mark and the CE certification.
Only for some products, such as Class I MDs, the compliance can be demonstrated by the Declaration of Conformity that is a self-certification issued by the Manufacturer.
In the last days, several non-compliant CE certificates for both PPEs and MDs have been found. The European Safety Federation has also published some of the most common cases of false CE certificates.
The question is: how to recognise a false CE certificate?
Here below the main mandatory elements of a CE certificate:
- Reference to the relevant regulation
- Identification of the Manufacturer (at least name and address)
- Identification of the Product (type of product; trade name; model)
- Classification (class IIa, IIb, or III for MD and category II, or III for PPE)
- Reference to the conformity assessment procedure carried out by the Notified Body
RPN is available to support companies in the regulatory check of the CE certification, please do not hesitate to contact us!