CE Marking "Direct" (NEMOMEC SRL)
We are increasingly being asked by Clients using or reselling machines to directly provide for the CE marking activities: for the past few years NEMOTEC has been organizing to satisfy the demand, through the partner company NEMOMEC characterized by the same corporate participation, same organization, only different scope of activities.
Over the years we have handled certifications of “self-built,” revamped or partially modified machines and plants imported from foreign markets: in each case we have supervised and then concluded the technical adaptation process and issued the CE declaration of conformity./p>
Preliminary Considerations and Feasibility Analysis
Some basic concepts:
• CE certifying a product (machine, plant, system, etc…) means signing a declaration (known as a “declaration of conformity”) that guarantees compliance with EU regulations (Product Directives) and the technical applicable standards; this is regardless of whether the product is new or existing, often modified over time.
• The date of the declaration of conformity is the focus of the certification process; consequently we have to comply the regulations and standards in force at that precise, considering the fact that from a purely legal point of view “backdated” documents are not allowed.
• As mentioned, even existing systems and machines (even if modified over time) will have to comply the actual regulations; the certification process cannot be based on past regulations in effect at the time of original construction.
• CE certifying any system is not just about dealing with “practical” and implementation compliance (e.g., mounting on additional guards); technical documentation is also a legal requirement, and must be comprehensive enough to demonstrate design and product compliance.
• Said documentation requirements also apply to existing and substantially modified machines and systems; this can lead to a number of potential additional issues and activities that are often initially underestimated (and that depend on how much original documentation is available, how much documentation needs to be updated, including plant schematics, calculations, etc.).
• Lack of technical documentation (particularly for existing machines and systems) may force additional activities, including, for example, the replacement of components and subsystems that are still functional but prove adequate certifying evidence (e.g., electrical panels and components, hydraulic parts and/or systems, structural elements, …).
• In the case of complex production lines or plants made up of several machines and sub-systems, these “initial” feasibility issues may impact not only the individual elements, but also the overall integration of the assembly. The case histories are too many to summarize here, but it is important to consider that it is always good to include certification aspects in the initial economic-budgetary assessment.
Breakdown of Service
The pattern of the division of services between our two companies is as follows:
• NEMOTEC – in charge of engineering, project control, technical documentation writing, support and interface with external suppliers and firms.
• NEMOMEC – in charge of verification, establishment and archiving of the Certification Technical File, final verifications, issuance of the Certificate of Conformity and physical marking of the product, possible interface with Notified Bodies and Authorities.
Other companies involved or to be involved in certification activities
While considering NEMOTEC‘s (and NEMOMEC‘s) predisposition to a turnkey management approach, this type of service often involves Third Party Companies, for the following tasks:
• Mechanical executive design: typically, NEMOTECElectrical/fluidic executive design: similar to mechanical design, referring to electrical panels and systems, pneumatic or hydraulic systems, with attached plant schematics.
• Mechanical implementation: putting in place mechanical adaptations, guards, etc., depending on what emerges from the safety analysis.
• Electrical/hydraulic/pneumatic implementations: similar to the mechanical activity, this activity may involve the issuance of CE certificates for sub-systems (e.g., new hydraulic power packs, new or rebuilt switchboards, etc…).
• NOTE functional safety (analysis and/or adjustment of safety circuits and devices) is one of the most critical and impactful processes in the certification journey; the choice of designer/realtor of electrical and fluidic systems is critical to ensure time and cost efficiency.
• Notified Bodies: in case of particular machines and/or industrial sectors, the mandatory involvement of a Notified Body (NOBO) may be required. In this case NEMOMEC will directly take care of the interface with the NOBO and choose the most suitable collaboration among the various active partnerships according to the type of sector and intervention needed.