Is the EU MDR Extension a Blessing or a Curse?

• What: Webinar – “Is the EU MDR extension a blessing or a curse?”
• When: Thursday, August 24^th 2023, 10:00 – 11:00 ET
• Where: Online Event
• How: Register Here
• Why: Join this session to better understand the effects of the EU MDR extension on manufacturers, and notified bodies, how to deal with it and what medical device manufacturers must do to stay compliant.

The extension of the EU MDR deadlines from the EU Commission was received positively by the medical device industry. The extension will impact manufacturers’ preparedness towards clinical documentation, certification, and workload for notified bodies as they get closer to the extension deadlines.

The EU Commission’s MDR transitional deadlines are:

• Class III custom made implantable devices – May 26, 2026
• Higher Risk Class III and IIb devices – December 31, 2027
• Lower Risk Class IIa and I devices – December 31, 2028

It is vital that medical device manufacturers use the extension as an opportunity and utilize this valuable time to get their certification processes within MDR regulations in order.

This featured presentation will be led by Celegence’s Joseph-Richardson Larbi, Director – Medical Device Regulatory Affairs and Joy Greidanus, Director – Medical Device SME. Our panelists will also be available for a live Q&A session after the presentation.

Celegence will be hosting the webinar on Thursday, August 24^th at 10 am ET. Register online now!

Webinar Presenter – Joseph Richardson-Larbi, Director – Medical Device Regulatory Affairs

• Joseph has 20 years of experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
• His key expertise includes the preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE marking, and notified body opinion submissions.
• Medical device industry – Joseph has experience in diabetes management devices, nicotine replacement therapy (NRT) devices and pressurized metered dose inhalers (pMDI).
• Joseph has worked for small, medium, and large Biotech companies such as Roche, OBG Pharmaceuticals, and Kind consumer Ltd.

Webinar Presenter – Joy Greidanus, Director – Medical Device SME

• Joy has more than 30 years of experience working in the medical device manufacturing industry as a Regulatory Affairs Professional.
• She has strong experience and expertise that includes US submissions, collaborative interaction with FDA, strategies for medical device, pre-market notifications, IDE applications, clinical trial notifications, research ethics committee submissions, developing / maintaining technical files and design dossiers, international marketing authorizations, risk management, design control, and regulatory compliance.
• Joy has worked with Cardinal Health, Becton Dickinson, Baxter, Teleflex Medical, Hospira, CareFusion, Fresenius Kabi USA, and TIDI Products LLC before Celegence.

• Practical aspects related to the implementation of EU MDR
• The four criteria which must be met to qualify for an extension
• Using the extension time wisely

• What does the extension mean to Manufacturers?
• What are the pitfalls to avoid during the extension?
• Learn how notified bodies deal with the extensions – common challenges and advice.
• What is the impact of the extension for legacy v/s new products?
• What does this mean for Brexit? How will Switzerland act?
• Updates; Confirmation Letter template now available from the Notified Bodies
• Have your most pressing questions answered during the Q/A session

This webinar is aimed towards those working for companies in the life sciences industry, particularly manufacturers of medical devices, with a special emphasis on:

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Device Design Managers
• Clinical Managers

“Is the EU MDR extension a blessing or a curse?” webinar will be held on August 24th, 2023, from 10:00 am – 11 am ET. Make sure you secure your place at the webinar by registering now.