In a recent article UKAS provided guidance on how to check that a certificate apparently provided by an accredited certification body was in fact valid. This was in response to an increase in reported fake certificates claiming certification against management system standards such as ISO 9001, ISO 14001 and ISO 45001, and in particular, during the current pandemic crisis, against ISO 13485 which covers medical devices.
The increased need for appropriate Personal Protective Equipment (PPE) has been a hot topic during the crisis, and the need to source PPE that meets the safety requirements for the European market is of paramount importance. Such products are required to comply with Regulation (EU) 2016/425, through an EU Type Test certificate which incorporates the CE Mark. However, in the same way that fake claims of accredited certification have been reported, there has also been reports of an increase in fake certificates displaying the CE Mark. This article clarifies the appropriate checks that can be taken to ensure that a CE marking is valid.
With the exception of very simple, low-risk products, CE Marking can only be provided by Notified Bodies. The competence and impartiality of these bodies is underpinned by accreditation, although it is a Competent Authority within each Member State that designates them as Notified Bodies. All Notified Bodies are included on the European Commission’s database of Notified Bodies (NANDO), which includes details of what activity they have been notified for.
* During the COVID-19 crisis there are alternative methods whereby it is lawful to supply PPE which has not been CE marked. The mechanism depends upon whether the PPE is to be supplied to the UK Government for distribution to Healthcare workers or whether it is to be supplied to the market. Both mechanisms require the PPE to meet with the essential Health and Safety requirements as laid down in Regulation (EU) 2016/425 and are restricted to PPE for the purposes of tackling the COVID-19 pandemic.
Further guidance for businesses and local authorities relating to PPE for use during the COVID-19 pandemic has been published by the UK Government.
NB: CE Marking can only be applied by Notified Bodies that are established within the European Union (including EFTA)
If the document to be verified is an EU Certificate, issued pursuant to EU Regulation 425/2016 on PPE by a Notified Body, this must contain at least the following information:
- a) name and identification number of the notified body ;
- b) name and address of the manufacturer and, if the application is made by the authorized representative, name and address of the latter;
- c) identification of the PPE covered by the certificate ( Type number );
- d) declaration certifying that the type of PPE meets the essential health and safety requirements applicable;
- e) if the harmonized standards have been applied in whole or in part, the references of these standards or parts of them;
- f) if other technical specifications have been applied, their references;
- g) if applicable, the level of performance or the protection class of the PPE;
- h) for PPE produced as single units to adapt to a single user, the range of permitted variations of the relevant parameters based on the approved base model;
- i) the release date , the expiry date and, if applicable, the renewal date or dates;
- j) any conditions connected with the issue of the certificate;
- k) for Category III PPE, which includes respiratory protection and protection from biological agents, a statement that the certificate is to be used only in combination with one of the conformity assessment procedures referred to in Article 19 (c). (i.e. that the manufacture of the product is subject to regular quality checks and/or inspections/). Each piece of PPE in Category III should also be accompanied by, or reference, an EU Declaration of Conformity, which should identify the name of the Notified Body responsible for this ongoing conformity activity.
PLEASE NOTE: The information referred to in points e), f), g) and h) may not always be present based on the design and construction choices of the various manufacturers.
Check the notification of the body that issued the certificate online
To be sure that the certificate containing the above elements has been issued by a Notified Body for this type of PPE, you can check the database of the European Commission which lists the bodies notified in Europe for the EU Regulation 425/2016. It is important to check specifically in the NANDO record for the PPE Regulation, as a Notified Body can also be notified for other Directives and Regulations. Notified Bodies that are responsible for the surveillance activities for Category III PPE (see (k) above) can also be checked here.
NB: It is necessary to verify that the type of PPE of interest is included in the specific notification.