Organization of Regulatory and Clinical Associates

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Organization of Regulatory and Clinical Associates

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Redmond, WA 98073

Home Current/Future EventsWebinar - MDR 2017/45 Implementation Delay Due to Challenges Presented by the COVID 19 Pandemic

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Today

Webinar - MDR 2017/45 Implementation Delay Due to Challenges Presented by the COVID 19 Pandemic

When:

Wednesday, June 10, 2020, 8:00 AM until 10:00 AM

Where:

Webinar - link will be emailed to attendees 2 days prior to the meeting.

Event Contact(s):

ORCA Admin

Category:

Webinar

Registration is closed

RSVP by Tuesday, June 9, 2020

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.

Please make sure that the following email address is in your Safe Sender list: mailer@mail2.clubexpress.com. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this email address.

You will receive an email 2 days prior to the meeting date with the webinar login instructions or after payment is processed if registering closer to the meeting date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.

PAID FEES ARE NON REFUNDABLE.

For webinar events, payment is REQUIRED at the time of registration.

Capacity:

100

Active Member (Regular, Student, Government)

No Fee

Non-Member

$60.00

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The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
This webinar will be recorded.

NEW START TIME is 8:00 AM PST

TOPIC: Main points:
-Remote auditing
-NB designations
-EUDAMED (May 26, 2022)
-Economic Operators: distributors and importers new
requirements (Suppliers)
-PMS
-PMC
-Vigilance
-Risk (EN ISO 14971:2019)
-Class I Medical Devices (grace period)
-EUDAMED (May 26, 2022)
-Certificates renewal

TOPIC DESCRIPTION: EU postponed MDR 2017/45 implementation due to the COVID-19 pandemic. Manufacturers of self-certified, EC marked product under the MDD/MDR as well as EC marked IVD products need to implement MDR new rules by May 26, 2021 instead of May 26, 2020 (As per Regulation 2020/561 amending EU 2017/45).
This allows the placement in the market of medical devices holding valid certificates under the current MDD/IVDD regulatory framework. There will not be a delay for the IVDR implementation scheduled on 26 May 2022.
Guidelines published by regulatory bodies on remote audits support auditing under specific context.

SPEAKER: Lena Huerlimann

SPEAKER BIOGRAPHY: Lena Huerlimann earned a Master of Science in Biology from the University of Zurich, Switzerland. Her thesis was based on an epidemiological study conducted at the Institut fuer Medizinische Mikrobiologie on methicillin-resistant Staphylococcus aureus. She has 23 years of experience in the pharmaceutical and medical device industry. In 2008, she became a full time Lead Auditor for Notified Bodies (NBs). Currently, she works as an independent Lead Auditor and RA Consultant for NBs, Registrars and independent customers. In this role, she helps companies implement, maintain and evaluate conformance of their internal policies and QMS documentation to applicable ISO harmonized standards, local and international regulatory requirement.

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1.5 points towards RAC re-certification