Webinar: EU Medical Device Regulation
April 17, 2019
Deliverables for Restricted Materials for EU Medical Device Regulation
On 17 April 2019, Claigan Environmental Inc. (www.claigan.com) will present a webinar on example deliverables for review of CMRs and EDCs for the EU Medical Device Regulation. The webinar will cover example outputs from review materials for category 1 CMRs or EDCs over 0.1% w/w that are invasive, or fluid or gas contacting.
Section 10.4.1 of the EU Medical Device Regulation (EU MDR) has requirements for identification of carcinogens, mutagens, and reproductive toxins (CMRs) and endocrine disrupting chemicals (EDCs) over 0.1% w/w in invasive, or fluid or gas contacting materials. The exact output requirements of section 10.4.1 of the EU MDR are the subject of much debate. There is no one set format, but companies need a solution that meets both the CE conformity assessment requirements of EU MDR and also the scrutiny of notified bodies. This webinar will discuss effective approaches that meet the requirements of EU MDR, are practical to complete, and can be updated effectively based on notified body feedback
The main topics to be covered in this webinar are –
- Section 10.4.1 of EU MDR
- What are CMRs and EDCs?
- What are the CMRs and EDCs likely to be in medical devices?
- Relationship between EU MDR and REACH SVHC process
- Process for identification of CMRs and EDCs
- Deliverable outputs
- Alternate approaches
- Risk mitigation
- Managing new CMRs and EDCs
- List of likely new EDCs
Due to the interest in this topic, two (2) webinars will be held on April 17 to accommodate a larger audience.
Webinars – EU MDR CMR and EDC Outputs
Time: 10am and 2pm EST
Duration: 1 hour plus Q&A
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