What to do when your product does not match a harmonised standard?
How do the notified bodies ensure a uniform handling of product documentation so that the result is more or less the same regardless of who is chosen on the EU list of notified bodies?
When a manufacturer wants or needs official confirmation that his product complies with the relevant directive e.g. the Radio Equipment Directive (RED) or the EMC directive, he can request a notified body to examine his product documentation. But how are the notified bodies aligned such that the outcome of an examination will be practically the same regardless which notified body you chose from the list of notified bodies provided by EU? This is important as the manufacturer cannot just go to another notified body if he does not like the examination result of the first one.
The available set of standards is never completeManufacturers lacking applicable standards for particular products has been the case since EU started the new approach where directives set the essential requirements and referenced standards provided the simplest means to comply.
The lack of standards lessened as directives matured, but recur when directives change or technology evolves faster than the standards development can follow suit.
In recent years the conversion of directives to New Legislation Framework has caused some disruption in the lists of standards listed under the LVD and the EMC directive, while the RED started over from scratch. A considerable number of radio parameter standards are still in the ETSI development pipeline or in queue with the EU for review prior to listing under RED.
Risk (of non-compliance) assessmentThe directives require that the essential requirements are met and the manufacturer is expected to perform a risk of non-compliance assessment demonstrating due diligence. This may be easy when harmonised standards, HS, providing presumption of conformity apply in full. When such standards are not available of do not fully cover the product in its intended and foreseeable use, then the manufacturer must close the gaps and alleviate the identified risk of non-compliance by other means.
In most cases the directives allow the manufacture to argue compliance based on relevant standards found outside the lists of HS for the directives or a selection of relevant tests to supplement standards, which apply in part.
The LVD and the EMC directive allow the manufacturer to issue the Declaration of Compliance (DoC) and affix the CE mark to the product when the underlying product documentation file is complete and supports the compliance assessment conclusion of compliant to the essential requirements of all applicable directives without the need to involve a notified body.
The RED requires the involvement of a notified body when compliance to article 3.2, i.e. the essential requirement of effective use of the spectrum, cannot be demonstrated by application in full of HS listed under RED, while the manufacturer is free to assess compliance to the other essential requirements of RED.
Notified body involvementFor the EMC directive, manufacturers may choose to involve a notified body in his conformity assessment.
For the RED the involvement of a notified body is in some cases mandatory. While the trigger for involving an RED notified body is most often a lack of HS to confer presumption of conformity with article 3.2, the EU type examination may include other essential requirements such as health and safety, article 3.1(a), and electromagnetic compatibility, article 3.1(b), of the product.
Obligations of a notified bodyThe directives and other EU legislation places significant requirements on the community of notified bodies and well as on each notified body individually, regarding procedures, communication, control, impartiality, active maintenance of competency, active participation in alignment activities within the notified body community, etc. A complete list of notified bodies can be found at EU’s Nando database (New Approach Notified and Designated Organisations), which offers multiple search function to find the notified body for the directive of interest.
EUANBThe EMC notified bodies are members of European Union Association of (EMC) Notified Bodies.
The members meet face to face every six months. The typical meeting agenda includes points such as updates regarding relevant standardisation activities, activities and decision on EMC related subjects within the EU organisation, review Technical Guidance Notes (TGN), discussion on topics of concern.
EUANB keeps the members connected via a mail responder. This enables quick dissemination of information, discussion of questions, debate and alignment within the notified body community.
In case a notified body must refuse, withdraw, restrict, or suspend a certificate, there are obligations to inform relevant EU and national authorities as well as all other notified bodies. EUANB provides a database for this purpose.
REDCAThe RED notified bodies are members of RED Compliance Association.
The REDCA is open to and has participation from a wider range of interested parties including consultants, test houses, manufacturers, authorities i.e. all who are willing to comply with the association’s rules and constitution and pay the annual member ship fee.
The REDCA and EUANB normally arrange their meetings concatenated at the same venue.
The structure and agenda for the REDCA meetings are similar to the EUANB. In addition, radio specific topics are on the REDCA agenda such as updates on allocation plans for radio spectrum within EU and status and plans regarding the backlog at ETSI and EU of radio parameter standards.
REDCA also keeps the members connected via a mail responder. This enables quick dissemination of information, discussion of questions, debate and alignment within the notified body community.
In case a RED notified body must refuse, withdraw, restrict or suspend a certificate, there are obligations to inform relevant EU and national authorities as well as all other notified bodies. REDCA provides a database for this purpose.
FORCE Certification A/SWith the merger between DELTA and FORCE Technology, DELTA’s notified body services continue with FORCE Certification A/S.
Our services remain the same, however, the main difference being that the service found under DELTA’s old Notified body number 0199 are reduced, while the continued services are now found under notified body number 0200.
Our participation in EUANB and REDCA enables us to continually provide state-of-the-art notified body services to our customers.