Translation of "Réparation chirurgicale selon le dispositif utilisé " (French → English) :

(2) ' accessory to a medical device' means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the device(s) to be used in accordance with its/their intended purpose(s); or to specifically assist the medical functionality of the medical device(s) in view of its/their intended purpose(s);

If no clinical investigation has been undertaken, they should verify that the device type in question and all the different types of risks linked to the device design, its materials, and its use are appropriately assessed by means of scientific literature or other existing clinical data so that no clinical investigation is needed; they should furthermore examine the special justification (3) needed for implantable devices and devices classified within class III according to Annex IX to Directive 93/42/EEC.

In particular, power should be conferred on the Commission to adapt classification rules for medical devices, to adapt the means by which the information needed to use medical devices safely and properly may be set out, to determine conditions for making certain information publicly available, to adapt the provisions on clinical investigations set out in certain Annexes, to adopt particular requirements for placing certain medical devices on the market or putting them into service, and to take decisions to withdraw such devices from the market for reasons of protection of health or safety.

(26) Power should also be conferred on the Commission to establish specific procedures, tests and requirements for type approval, as well as a revised measurement procedure for particulates and a particle number based limit value, and to adopt measures concerning the use of defeat devices, access to vehicle repair and maintenance information and test cycles used to measure emissions.

According to the provisions set out in paragraph 8.1.3 with any buckle having been pre-conditioned according to the requirements of paragraph 7.2.1.7 such that the appropriate requirements of paragraph 7.1.4 (for the overall performance of the child restraint) and paragraph 7.2.1.8.1 (for the performance of any buckle under load) are complied with.

Now, I feel that the issue here is not which devices should be used in aircraft to reduce noise, for standardised procedures exist to control the levels of aircraft noise, but that the important thing is for the noise limits not to be exceeded.