Clinical Evaluation Report (CER) Services:

Companies that market medical devices in Europe must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745.

Stricter clinical data requirements are now required under the MDD and will continue under the MDR

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    CERs are very labor intensive requiring specialized clinical/regulatory experience

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    There is increased scrutiny on clinical data

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    CERs are required for all devices regardless of risk class and must be updated at least annually

  • 4
    Planning, collection and analysis of clinical data, and the development of compliant CERs should happen now

MCRA has a qualified and experienced team of clinical writers that have been successfully working with several clients as an extension of their internal team for all stages of the CER process:

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    Years of Experience Developing New CERs and Updating Existing Ones

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    Capability to Conduct a Literature Review and Analysis Across Multiple Databases with Multiple Reviewers

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    Integration of Clinical, Regulatory, & Quality Experts Who Understand the Content of a Successful CE

  • 4
    Capacity to Act Independently on All Components with the Exception of Internal Data Required from the Sponsor
MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise

GLENN STIEGMAN

Vice President Clinical and Regulatory Affairs

Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions Read More

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