Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

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Medical Device Clinical Evaluation Reports: Complying with European Guidelines and the New MEDDEV 2.7/1 Rev. 4 Guidance

The main challenge for device companies in developing a Clinical Evaluation Report (CER) is making the justification that the available data is sufficient to support the safety and performance of a device.

There are a number of requirements per the European Commission’s Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) for medical device companies to follow as they relate to clinical data.

The new EU MDR language was finalized in February and will likely be voted in before this webinar takes place.

One of the provisions in the new EU MDR restricts the types of clinical data manufacturers can use in CERs. The regulations can become effective as early as May. Manufacturers would then have three years to comply with the MDR and five years to comply with the IVDR.

Join Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — when she discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance.

You'll learn:

  • An understanding of the requirements of CERs and specifically what is considered sufficient clinical data
  • An analysis of recent findings from notified body assessors based on MCRA experience, specifically detailing expectations by notified bodies of what should be contained in the CERs
  • An understanding of the finer points related to the inclusion of equivalent comparators and when they are appropriate
  • An understanding of why cross-functional inputs from regulatory, clinical, quality, labeling, product development, post-market surveillance, etc. are needed
  • Best practices for completing CERs, complying with the regulations including the new MEDDEV 2.7/1 Rev 4 guidance
  • A discussion of what most experts consider one of the most significant provisions in the EU’s new MDR policy initiative — one involving important restrictions on the types of clinical data manufacturers can use in CERs

Order today and establish a process for strategizing and executing your CER.

  • Medical Device Presidents and CEOs
  • Regulatory Affairs Management
  • Clinical Affairs Management
  • R&D Management

Michelle McDonough, Associate Director, Regulatory & Clinical Affairs, Musculoskeletal Clinical & Regulatory Advisers

Michelle McDonough joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions including 510(k)s, PMAs, IDEs, Pre-Submissions, Technical Files, and Clinical Evaluation Reports, as well as, the management, design, and implementation of pre- and post-market clinical studies. Additionally, Michelle reviews company design history files, labeling, and clinical protocols for regulatory compliance, performs due diligence reviews of devices, designs and reviews pre-clinical and animal testing for device companies, develops initial and continuing review submissions for IRB approval, and oversees data management of clinical projects.