In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices – Webinar

• What: Webinar – Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices
• When: Tuesday, February 22nd at 10 am (EST)
• Where: Online Event
• How to Register: Navigating the In Vitro Diagnostic Regulation (IVDR)
• Why: Join us to examine the technical documentation specifications for IVD compliance with special attention to legacy devices, the labelling requirements, and what to consider when managing an RA team working towards IVDR compliance.

While the industry has been preparing for some time, the next few months will be critical for the May 2022 date of application. Manufacturers of legacy devices will have to be keenly aware of how the IVDR will affect their plans and processes. The labelling requirements for the Unique Device Identifiers (UDI) are a significant hurdle on their own, as UKCA marking will also play a role for companies with a strong European presence outside of the EU.

This featured presentation will be led by Celegence’s RA/QA Subject Matter Expert, Manuel Martin, who will also be available afterwards for a live Q/A. In this session you will hear key insights into the technical documentation specifications with special attention to legacy devices, the regulatory labelling requirements, and what to consider when managing an RA team working towards IVDR compliance.

Celegence will be hosting the WEBINAR on Tuesday, February 22nd at 10 am EST. Register online now here! 

Manuel Martin is an experienced Quality and Regulatory Professional with strengths in people motivation, coaching and mentoring multicultural teams, offering over 20 years of experience in the global medical device space, pharmaceutical and biomedical sectors, including MDD-MDR, IVDD- IVDR and Notified Body expertise.

He is a skilled leader and mentor, with high performing multi-site team skills, partnering with regulatory experts around the world to develop and deliver Quality and Regulatory strategy in the support of business portfolios. He also has experience in tailoring all adjacent business functions to align with corporate strategic goals, whilst maintaining compliance with internal and global requirements.

• The obligations of manufacturers of legacy devices for IVDR compliance
• Reclassifications under the IVDR
• The impact that the UKCA marking requirements will have on your process and plans
• The IVDR best practices for navigating the regulations and maintaining market access well beyond the date of application

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

• Learn how to develop a sound regulatory approach for your labelling requirements under the new regulation
• Better understand how the key elements of IVDR will affect manufacturers of legacy devices
• Hear Manuel’s key insights into the technical documentation specifications
• Examine examples and relevant case studies
• 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 IVD 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

Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices webinar will be held on Tuesday, February 22nd at 10 am EST. Make sure you secure your spot at the webinar by registering now.

Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant IVD device expertise to navigate the EU IVDR regulations and gain market approval. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you during this webinar and hope that you can join us then.

Celegence’s comprehensive support for creating and maintaining required documentation can help ensure your organization’s IVDR compliance. Reach out to us at info@celegence.com to learn more, contact us online or read more about Celegence’s medical device services.