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MEDDEV 2.7/1 Revision 4: Guidelines for Clinical Evaluations Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016.
While there was only a single guidance document on clinical evaluation and investigation in 2019, the MEDDEV documents are now being replaced or supplemented more and more at this point. In 2020, seven additional documents were published to provide guidance to manufacturers.
MEDDEV 2.7/1 Revision 4: Guidelines for Clinical Evaluations Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016.
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.
The acronym CE stands for Conformité Européene, which translates to \u201cEuropean conformity.\u201d Basically, in order to obtain the CE mark, a conformity assessment will need to be conducted based on the risk class of the medical device to ensure it complies with all applicable regulations required by the MDR.

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MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices.
The clinical evaluation report must be updated continually throughout the lifetime of your device as part of the post-market surveillance and vigilance requirements.
MEDDEV 2.7/1 Revision 4: Guidelines for Clinical Evaluations Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016.
Class IIa Devices \u2013 Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days.
MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices.

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