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Medical Device CE Marking Approval Process

Medical Device require CE marking before sold in the EEA. CE Marking proves that your Medical Device has been assessed by Notified Body and meets EU safety, health and environmental protection requirements.

To affix the CE marking to your Medical Device / Medical Instruments / Medical Disposables / Medical Software / Medical Machinery / Home Health Care Devices you must put together a technical file proving that your product fulfils all the EU Medical Device Regulation (MDR) requirements.

After CE Certification as per MDR manufacturer/importer need to create the CE marking logo on the medical device. The CE Marking logo must be visible on the device primary packaging and secondary packaging.

How to obtain CE Certification? How MDR CE Marking Approval Process? How a Technical File is prepared? many of the questions are answered in the below flow chart.


CE Marking Approval Process

We have invested huge on developing the skills of inhouse team of CE Certification consultants over the last four years to make I 3 CONSULTING a truly global regulatory consulting organization for global medical device manufacturing clients. We uniquely offer multidisciplinary insights into Risk Analysis, Biological Evaluation, Clinical Follow up, Clinical Evaluation by minimizing the cost of travelling and accommodation by doing business in cloud. With a common, consistent strategy and structure of our organization, we serve our global and local clients with the same intensive focus on quality suitable for early CE Certification of your Medical Device.

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