Webinar Combination Products - Notified Body Opinion MDR Article 117 - Celegence

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117 – Webinar

  • What: Webinar on Combination Products – Seeking a notified body opinion according to MDR article 117
  • When: April 21st at 10 am (EST)
  • Where: Online Event
  • How: Register online
  • Why: Join us to understand how to best prepare, interact, and fulfill the requirements for a Notified Body opinion on your organization’s combination product.

Webinar Background

Due to the ever-expanding prevalence and complexity of Drug Device Combination (DDC) products, the EU MDR has put these products under greater focus. Manufacturers of DDCs will now be required to receive Notified Body opinions to ensure the safety and performance of the device element of the combination product. Outlined in Annex 1 of the MDR, the General Safety and Performance Requirements (GSPRs) are required to be met for combination products prior to placing them on the market. The products in scope of this requirement are integral Drug Device Combination products and products in which both the medicinal product and device are to be used exclusively within the given combination.

Join this Celegence featured presentation to understand our expert Joseph-Richardson Larbi’s perspective on how to best prepare, interact, and fulfill the requirements for a Notified Body opinion on your organization’s combination product.

Celegence will be hosting the WEBINAR on April 21st at 10am EST. Register online now.

EU MDR - Checklist - Celegence Life Science

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Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

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EU MDR - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW

Webinar Featured Presenter – Joseph-Richardson Larbi

Joseph-Richardson Larbi has 18 years of experience in Medical Device (MD & IVD) Regulatory and Quality strategies (from design development to market launch and post marketing activities – compliant to MDD/MDR/IVDR/ISO 13485/9001 Quality Management Systems).
He is experienced in MD CE certification, ISO 14971 Risk Management, Manufacturing and Supplier Management, Manufacturing Verification and Validation, Post Market Surveillance, Clinical Evaluation Reports, Drug Device Combinations, regulatory relationship management, and advance knowledge of FDA Drugs, Biologics, and Biosimilars (IND, NDA, BLA).

Webinar Combination Products Agenda - Notified Body Opinion MDR Article 117 - Celegence

Webinar Agenda: Seeking a Notified Body Opinion According to MDR Article 117

  • Explanations of Article 117 requirements for single integral drug-device combination products, providing an overview of the current situation and the challenges ahead from the perspective of both the industry members and authorities.
  • A discussion on how to address Article 117 of the MDR, which established new compliance obligations for drug-device combination products.
  • Practical examples and case studies.
  • Q/A session with our expert panelist.

Webinar Learning Objectives

Upon conclusion of the program, you will be able to:

  • Comprehend the impact of Article 117 of the MDR on Drug Device Combination (DDC) products.
  • Understand the current situation and the greatest obstacles from the perspective of EU regulators and medical device
  • Gain an understanding of the General Safety and Performance Requirements (GSPRs) which are to be met for combination products prior to placing them on the market.
  • Prepare your RA team for Notified Body Opinions under article 117 to ensure a seamless transition and remove any risk of future non-compliance.

Who Should Attend?

This webinar would support those working for companies in the life sciences, including manufacturers of medical devices, with a special emphasis on:

  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Packaging Development Product and Project Managers
  • Technical Writers and Managers
  • Operations and Design Managers
  • Clinical Managers
  • Authorized representatives in Europe
EU MDR - Checklist - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW
EU MDR - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW

Webinar Sign Up

Combination Products: Seeking a Notified Body Opinion according to MDR Article 117 webinar will be held on April 21st at 10am EST. Make sure you secure your spot at the webinar by registering now.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing, and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you through the webinar and hope that you can join us then.

Webinar Combination Products Sign Up - Notified Body Opinion MDR Article 117 - Celegence

Celegence – Services and Solutions to Support the Life Sciences

Manufacturers of Drug Device Combination (DDC) products should seek regulatory advice and operational support from the expert Celegence team to ensure that essential documentation and clinical evidence for your product portfolio complies under the EU MDR. To discuss how our team can strategically partner with yours, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

For more information on how Celegence can help improve your Regulatory Operations with Learning Management, reach out to us at info@celegence.com, contact us online or read more about Celegence’s regulatory operations capabilities.