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