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Subject: "grandfathering" approach In Europe all medical devices (including implants with bioactive coatings or tissue engineering products) must meet the applicable ‘essential requirements’ on safety, performance and labelling as outlined in the Medical Device Directive (MDD) 93/42/EEC. Safety requirements are not restricted to patients but include users and, where applicable, other persons. The fulfillment of the essential requirements has to be demonstrated especially by the manufacturer for all devices whether they are new or whether they have already been on the market in former times. Under the MDD there are no provisions for a "grandfathering" approach as known for example in the US. Labelling may be and in general is required by each Member State in its national language(s); the use of symbols is recommended.Подскажите, пожалуйста, как здесь перевести предложение с этой фразой? Очень надо. Спасибо. |
| Trix, это прекрасно, конечно, что Вы и здесь поддержали на должной высоте марку нашего форума. Кроме "браво", ничего другого не скажешь. Но только смотрите не "разбалуйте" участников с другими языками, а то засыпят нас вопросами! :) |
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