How do I obtain the CE marking for medical devices? We explain it in three steps.

As a company specialising in the CE marking of medical devices, we have prepared a simple outline of this process. This makes it easier for medical device manufacturers to understand the various steps involved and we encourage you to contact us, whether you want to contract our services or have any questions.

Our first piece of advice is to run the processes in parallel, as they require information that is intertwined.

1.- In order to market the medical device, a prior manufacturer’s licence must be obtained from the AEMPS. This phase can take up to three months, and the Agency can stall the process for up to ten days each time it requests corrections. The instructions are in the document PS-01-2019, which you can download and upload in the AEMPS application.

2.- At the same time, we recommend you to prepare the technical documentation according to the current regulations (745/2017 and 746/2017), as well as to verify if you need to resort to a Notified Body. This process can take up to 12 months!!

As you prepare the necessary information to verify the CE marking of medical devices, you generate the documentation for the quality management system, based on the ISO 13485:2016 standard, which is validated by the Certification Bodies. ISO 13485 certification is not mandatory, but it facilitates international expansion and is a guarantee of the company’s commitment to quality standards.

Which products require certification by a Notified Body?

Only Class I medical devices can obtain CE marking without the need for certification by a Notified Body. Even so, it is essential that they have all the technical report documentation in order.

Do you have doubts? Interested in our post? Do you feel that something is missing? Do not hesitate to write to us if you have any questions, we are happy to help you: contact@episkeymedical.com

 



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