EU Medical Device Regulations
Restricted Materials Compliance
On 28 June 2017, 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
- Information in the instructions
- High risk materials
- Practical approaches to compliance
- Legacy versus new designs
Due to the anticipated interest in this topic, two (2) webinars will be held on June 28 to accommodate a larger audience.