This week I'm covering a new app in the PLM 360 App Store, the CE Marking App. The purpose of this app is to manage the approval stages needed for the affixing of the CE marking on your products. With this app you can also create the EC Declaration Of Conformity and get an automatically generated document ready to print and sign for the official bodies to approve.
Background to CE Marking..
CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (e.g.safety, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), has had it examined by a notified conformity assessment body.
Using the CE Marking App
|A visual indicator will tell you if you have completed all the sections and your product is approved|
Stage 1: Identify the applicable Directive(s)
|Stage 1: Identify the applicable Directive(s)|
Stage 2: Identify the applicable requirements of the Directive(s)
|Stage 2: Identify the applicable requirements of the Directive(s)|
Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.
Stage 3: Identify an appropriate route to conformity
|Stage 3: Identify an appropriate route to conformity|
Although the process is always a self-declaration process, there are various routes to conformity depending on the directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some extent, have a mandatory requirement for the involvement of an authorised third party or "notified body".
Stage 4: Assessment of the product's conformity
|Stage 4: Assessment of the product's conformity|
Stage 5: Compile the technical documentation
|Stage 5: Compile the technical documentation|
Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.
Technical documentation will usually include:
- Technical description
- Drawings, circuit diagrams and photos
- Bill of materials
- Specification and, where applicable, Declarations of Conformity for the critical components and materials used
- Details of any design calculations
- Test reports and/or assessments
- EC Declaration of Conformity
Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA). Using this App you have a permanent record to keep.
Stage 6: Make a Declaration and affix the CE marking
|Stage 6: Make a Declaration and affix the CE marking|
Declaration of Incorporation.
The requirements for the Declaration vary slightly, but will at least include:
- Name and address of the manufacturer
- Details of the product (model, description and the serial number where applicable)
- List of applicable sectoral Directives and standards that have been applied
- A statement declaring that the product complies with all of the relevant requirements
- Signature, name and position of the responsible person
- The date that the Declaration was signed
- Details of the authorised representative within the EEA (where applicable)
- Additional Directive/standard specific requirements
Once completed you can approve the Declaration of Conformity using the workflow below:
|Approval Proces for the Declaration of Conformity|
Using the Advanced Print views in PLM 360 your Declaration of Conformity will automatically be created for you
|A PLM 360 Print view is automatically created|
The whole process is tracked using the CE approved 1 to 6 stage workflow process.
|CE approved 1 to 6 stage workflow process.|
Once a Declaration of Conformity has been completed, the final step is to affix the CE marking to the product. When this has been done, the CE marking requirements have been met.
I hope you find this CE Marking PLM 360 App useful, I'd be interested to know what Innovative products have been managed using this App!
Thanks for reading....Mike