How to handle the nanomaterials requirements of EU Medical Device Regulation.
OTTAWA, ON, Aug. 17, 2020 /CNW/ - On August 26 2020, Claigan Environmental Inc. (www.claigan.com) will present a webinar on common practices to manage the nanomaterials requirements of the EU Medical Device Regulation (MDR). Unbeknownst to most medical device manufacturers, their product normally contains ingredients that meet the definition of a nanomaterial. This webinar will focus on the definition of nanomaterials, the requirements under EU MDR, common nanomaterials in medical devices, and common practices for EU MDR compliance for nanomaterials in medical devices. As nanomaterials become more regulated, this webinar should also serve as an excellent basis for non-medical device manufacturers in understanding how to handle nanomaterials as they become more regulated in other products.
Most inorganic additives (colourants, stabilizers, fillers, and flame retardants) embedded in plastics meet the EU definition of a nanomaterial in their original powder form. For many medical device manufacturers, the question is how to handle the presence of those nanomaterials in their plastics. Claigan's webinar will discuss the EU definition of nanomaterials, the broad requirements for nanomaterials under EU MDR, and practical options that are being adopted by medical device manufacturers.
The webinar will also touch on the overlap with other EU MDR restricted materials requirements such carcinnogens, mutagens, and reproductive toxins (CMRs) and endocrine disrupting chemicals (EDCs).
The main topics to be covered in this webinar are -
- EU definition of a nanomaterial
- Definitions of nanomaterials, aggregates, and agglomerates
- EU Medical Device Regulation requirements for nanomaterials
- Standard nanomaterials embedded in plastics
- Practical approaches for medical devices and embedded nanomaterials.
- Overlap with compliance processes for CMRs and EDCs.
Due to the interest in these topics, two (2) webinars will be held on August 26 to accommodate a larger audience.
Webinars - Nanomaterials and EU MDR
Date: 26 August 2020
Time: 10am and 2pm EST
Duration: 1 hour plus Q&A
To Register: https://attendee.gotowebinar.com/rt/4365352941708092944 or on Claigan Website at www.claigan.com/webinars
About Claigan Environmental (www.claigan.com)
Claigan is a leading provider of regulatory consulting and ISO 17025 accredited laboratory testing for restricted materials legislation. Claigan analyzes and tests hundreds of products a year for restricted materials compliance. Claigan is dedicated to providing practical solutions for supply chain due diligence and social responsibility. At Claigan, we believe in 'More Results. Less Journey.'
SOURCE Claigan Environmental Inc.