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PRODID:-//Journal of Medical Device Regulation - ECPv4.9.3.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
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X-WR-CALNAME:Journal of Medical Device Regulation
X-ORIGINAL-URL:https://globalregulatorypress.com
X-WR-CALDESC:Events for Journal of Medical Device Regulation
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20210511T090000
DTEND;TZID=Europe/London:20210512T170000
DTSTAMP:20260725T173552
CREATED:20201111T131802Z
LAST-MODIFIED:20201111T131802Z
UID:12922-1620723600-1620838800@globalregulatorypress.com
SUMMARY:Introduction to the In-Vitro Diagnostic Regulation (IVDR)
DESCRIPTION:Location: Online webinar \nDescription: Regulation (EU) 2017/746 on in vitro daignostics\, which came into force in May 2017 with a transition period of five years\, is intended to strengthen the current approval system for IVDs and makes substantial changes to the existing IVD Directive (98/79/EC). The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force rules which\, for the first time\, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80% of all devices will now require some form of conformity assessment by a Notified Body. This seminar will clarify the requirements applicable to IVDs under the new Regulation\, highlight the major changes to responsibility and product data expectations\, and provide a thorough understanding of the impact on the industry. \nOrganiser: Management Forum \nContact: +44 (0)20 7749 4730 \n
URL:https://globalregulatorypress.com/event/introduction-to-the-in-vitro-diagnostic-regulation-ivdr/
ATTACH;FMTTYPE=image/jpeg:https://globalregulatorypress.com/wp-content/uploads/2020/05/IVDs.jpg
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