New version of MEDDEV 2.7.1 Revision 4: Key changes and clarification
Revision 4 of the MEDDEV guidance document 2.7.1 was released by the European Commission
on 1st July 2016. This document provides information to manufacturers on conducting a
clinical evaluation, including demonstration of scientific validity of your data and
conclusions. The document also covers requirements specifically for Post-Market
Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF).
While the new version does include some new requirements, the document principally
clarifies a number of the existing requirements, providing more detail on what is
expected of manufacturers conducting a clinical evaluation. For example, there is more
information on state of the art, equivalence and risk-benefit profiles. The new version
also includes examples, helping manufacturers to understand what is required.
The new Revision is beginning to align with the European Medical Device Regulation,
transition to which will require conformity to the requirements of the new Revision of
This webinar will explore the key changes, discussing the new requirements and noting
the main clarifications within the guidance document. It will highlight the areas for
you to be aware of and consider when conducting clinical evaluations.
Amie Smirthwaite is a Product Technical Specialist and Scheme Manager
for the Orthopaedic and Dental team at BSI. She has nearly 20 years' postdoctoral
experience, covering new product development, production, quality system management and
regulatory affairs within the medical devices industry.
Monisha Phillips is the Global Head of the Orthopaedic & Dental
Devices team at BSI. Since joining BSI in 2008, Monisha has experience as a technical
specialist in the Orthopaedic & Dental Devices team, and has also spent time as a
technical specialist in the General Devices team prior to becoming Global Head.