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MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

In June 2016, the MEDDEV 2.7.1 rev 4, the European guidance on the clinical evaluation of medical devices (MD) was published. The issuance of this guidance happened shortly after the publication of the text of the future Regulation on the Medical Device (MDR) of 15 June 2016, which anticipates many new requirements for clinical evaluation. Although, the MEDDEV 2.7.1 rev 4 does not revolutionize the approach on Clinical Evaluation, it does significantly increase the demands on the content of the file. It also shows that the guidance is beginning to align with the upcoming Regulation, a helpful tool for medical device manufacturers looking to operate their transition to the new regulatory requirements. The rev 4 outlines clinical evidence requirements for both unapproved technologies, as well as products that have been on the market for an extended period.