Medical Device Directive is one of the most complex directive and one which involves strict vigilance by the European Authorities. Steps for CE marking for Medical Devices of Class 1s , IIa, IIb and III are as follows
a) Implement a quality managment system ISO 13485:2012 as per annex II & V of MDD (not required for class I non sterile non measuring devices ). b) Appoint an European authorized representative (required by non EU manufacturer only) c) Apply General & product specific standards as applicable to the medical device particularly Biocompatibility ( ISO 10993 series for Implants and IEC 60601 series for Electromedical products d) Prepare a technical file comprising of detailed manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc. e) Submit the technical file & QMS documents to notified body for approval. f) Notified Body conducts onsite audit through approved auditors. g) Translate IFUs & labels to the local language of the country to which you want to export.
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