Medical Device Regulations for custom-made devices: answers to ten important questions
نویسندگان
چکیده
The 1990s saw the introduction of three European directives that aimed to harmonise medical device legislation within Union (EU) and these were given effect in United Kingdom (UK) by Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). Dental professionals EU who manufactured custom-made devices required do so accordance with relevant requirements one directives, Council Directive 93/42/EEC (Medical Device [MDD]). MDD has been replaced Regulation 2017/745 [EU MDR]) this paper answers some important questions regarding ways which affects provision a dental setting.
منابع مشابه
Ten common questions (and their answers) on medical futility.
The term medical futility is frequently used when discussing complex clinical scenarios and throughout the medical, legal, and ethics literature. However, we propose that health care professionals and others often use this term inaccurately and imprecisely, without fully appreciating the powerful, often visceral, response that the term can evoke. This article introduces and answers 10 common qu...
متن کاملQuestions and Answers about Ten Formal Methods
B description speci cally helps to identify the nature of the service o ered to customers from the customer viewpoint. Z animation has made it possible to answer the following questions about the domain: The same service cannot be provided twice. If there is an authority for providing a service then it will be provided. QNAP2 and SWAP suggest di erent ways of con guring systems e.g. types of sc...
متن کاملAnswers to the Top Ten Input Modeling Questions
In this tutorial we provide answers to the top ten inputmodeling questions that new simulation users ask, point out common mistakes that occur and give relevant references. We assume that commercial input-modeling software will be used when possible, and only suggest non-commercial options when there is little else available. Detailed examples will be provided in the tutorial presentation. 1 WH...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: BDJ team
سال: 2022
ISSN: ['2054-7617']
DOI: https://doi.org/10.1038/s41407-022-0802-5