During operation we are part of compliance challenges, and shall be looking for reliable source of information, where we can provide evidence to management why we need to deal with it!!!

One independent source of information can be the BG itself, pls read below.

SEE: Repairs and modifications to products (page 247.)

After they are placed on the market, products may be subject to life extension processes. While some of these processes intend to maintain or restore the product to its original condition, others imply that substantial modifications are made to the product.

A product, which has been subject to important changes or overhaul after it has been put into service must be considered as a new product if:
i) its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment;
ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant Union harmonisation legislation; and
iii) the product is made available (or put into service if the applicable legislation also covers putting into service within its scope).
This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question.

Where a modified product (38) is considered as a new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the modified product has to be considered as a new product, then the compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product.

In any case, a modified product sold under the name or trademark of a natural or legal person different from the original manufacturer, should be considered as new and subject to Union harmonisation legislation. The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant Union harmonisation legislation. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market and the new manufacture's name and contact address must be indicated on the product. However, the technical documentation has to be updated in as much as the modification has an impact on the requirements of the applicable legislation. It is not necessary to repeat tests and produce new documentation in relation to aspects not impacted by the modification. It is up to the natural or legal person who carries out changes or has changes carried out to the product to demonstrate that not all elements of the technical documentation need to be updated. The natural or legal person who carries out changes or has changes carried out to the product shall be responsible for the conformity of the modified product and draw a declaration of conformity, even if they use existing tests and technical documentation.

Products which have been repaired (for example following a defect), without being considered as new products do not need to undergo conformity assessment again, whether or not the original product was placed on the market before or after the legislation entered into force. This applies even if the product has been temporarily exported to a third county for the repair operations. For certain products, manufacturers are required to provide spare parts to other third parties to perform the repairs, and for a certain minimum period of time (39). Such repair operations are often carried out by replacing a defective or worn item by a spare part, which is either identical, or at least similar, to the original part (for example modifications may have taken place due to technical progress, or discontinued production of the old part), by exchanging cards, components or sub-assemblies. If the original performance of a product is modified (within the intended use, range of performance and maintenance originally conceived at the design stage) because the spare-parts used for its repair perform better due to technical progress, this product is not to be considered as new according to Union harmonisation legislation.

Thus, maintenance operations are basically excluded from the scope of the Union harmonisation legislation. However, at the design stage of the product the intended use and maintenance must be taken into account (40).

Access to design stage and its compliance documentation such as Ex certificates, DoC, IOM, drawings, inspection sheets, maintenance and repair sheets, Ex personnel competency certs can be and are relevant in terms of lifetime tracking.

link: https://lnkd.in/dTsJyytQ

Keep up the good work!

Arpad
veress@exprofessional.com