What is MEDDEV 2.7/1 Rev. 4?
MEDDEV 2.7/1 Rev. 4 Definition
MEDDEV 2.7/1 Rev. 4 is a document published by the European Commission which provides guidance to manufacturers on how often they should update the clinical evaluation of their medical devices and introduce new methodologies. The document also specifies the roles and actions required by notified bodies.
FAQs
What is MEDDEV?
MEDDEV is an acronym for MEDical DEVices Documents. The MEDDEV Guidance Documents are created on behalf of the European Commission by several working groups to help stakeholders in implementing medical device directives. The MEDDEVs encourage manufacturers and notified bodies involved in conformity assessment procedures to have a common approach.
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Does MDR replace MEDDEV?
The former MEDDEV documents that applied under the MDD are gradually being replaced with MDCG guidance documents under the MDR and IVDR as part of the transition from MDD 93/42/EEC to the new MDR 2017/745. Although these texts are not legally binding, they should be considered and implemented.
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How much does a clinical evaluation report cost?
A cost of preparing a clinical evaluation report can range between $3,000 and $8,000, depending on the classification of the medical device.
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