Provita stands for individual product developments and adjustments and has done so for many years. If our standard products do not entirely meet your needs or market demands, we are at your disposal to help you develop a suitable solution.
In this context, we point out that we do not automatically check all customised versions for standard and legal compliance, as the regulations for medical products require extensive analysis, test, audit and evaluation activities, depending on the product type. The ‘distributor’ and/or operator is responsible for achieving and declaring ‘compliance’, depending on the product and application.
The distributor or operator is to ensure the product's conformity BEFORE its first use, and to ensure the safe use of the product through clear labelling and user training pursuant to MDR [German medical products law] and MPBetreibV [German medical devices operator ordinance] and any other local regulations that may apply.
Changes to electrical products, such as lighting, may invalidate the current approval. Product changes may also affect the electromagnetic compatibility (EMC).
For wall and ceiling rail systems in particular, the overhead operation is to be considered, as well as the static factors (also see ‘Static & Installation Instructions’). Changes to the product here, for example, to the leverage effect on the ceiling mount, its connections and wall rail systems may cause a risk of over overloading.
The corresponding custom-made products will be identified with an –X after the article in the listing status.
We mark drawings of customised solutions with ‘Not for series production’.
We are happy to clarify any questions you may have.
You can also turn to provita's Sales Team for any questions.