A notified body will assess class I medical devices only in the cases when they are supplied sterile or are equipped with measuring function.
Because of that most lowest risk class medical device manufacturers are on their own when they are preparing the technical documentation of their devices.
From now on SGS Fimko will serve also class I medical device manufacturers. Our expert will supply the guidance and check list for the required form and contents of technical documentation and will assess the supplied documentation according to the requirements of MDD Annex VII. Result of the assessment will be a Technical Documentation Review Report.
You can use the Report to indicate that an independent and competent third party has assessed the technical documentation to meet the requirements.
Please contact our sales to receive an offer for the review service!
SGS Fimko Ltd
+358 9 6963 61