translation

[Tang, Chi]

Please help me to translate the following sentence. Thanks chi

where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC

[henry Hsu]

hi! I try my best to resolve this difficult sentence! just take it only for referance.
當設計的物品被組合為一整體, 實質的部分在65/65/EEC的規定中第一條裡的解釋
可視為一種醫療產品.

[woooooooolf]

where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC.

當某設備 將某一可能被（article 1 of Directive65/65/EEC）視為藥物的物質當做整體的一部份，而加以併入時...


主要句子：
where a device incorporates A SUBSTANCE ......

1.（as an integral）, 2. (if used separately) 是插入的斷句。
1. 將 substance 當做自體的一部份而併入
2. 分開使用