EU Medical Device Regulation Webinar
Автор: Claigan Environmental
Загружено: 2019-01-17
Просмотров: 4102
Claigan Environmental Inc. will present a webinar on the new restricted materials requirements in the EU Medical Device Regulation (2017/745). This webinar will discuss, in practical terms, the new restrictions, justification, and labelling requirements for certain restricted materials.
The new EU Medical Device Regulation (MDR) contains new requirements for category 1 carcinogens, mutagen, and reproductive toxins; endocrine disruptors, and allergens. In this webinar, Claigan will describe in detail the new requirements and specific restricted materials that are commonly found in medical devices, as well as steps to managing compliance in a practical way. The webinar will further explore practical approaches to compliance for restricted materials requirements for both legacy and new medical devices.
The main topics to be covered in this webinar are –
EU Medical Device Regulation (MDR) – Restricted Materials
Scope and timeline
Design and manufacturing
Justification
Labelling
Information in the instructions
High risk materials
Practical approaches to compliance
Legacy versus new designs
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