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