Medical Device Regulation is becoming fully applicable as of May 26 2020. This date is just around a corner and many manufacturers are wondering what is the secret formula to implement the MDR successfully and go through the transition period as smoothly as possible. Here is what we suggest.
Start with the basics – information is key.
MDR brings a whole new set of compliance requirements. Our consultants are here to guide you along the way and assist you, but Obelis can help manufacturers regardless if you are our client or not. Our team is following the process from the beginning and is immediately uploading all the news, guidance documents and templates on MDlaw.eu, which can become your go-to platform to search for any document and clarification of the MDR and medical device law, in general.
We are highly recommending the manufacturers, and especially their Regulatory Affairs teams, to take time and read the requirements. This will help you understand better the novelties. As always, it is easier to understand something you have read yourself, especially prior to any communication with the Notified Bodies. Do not forget that we still expect more MDR guidance and implementation acts to be published, therefore your work should not stop at the level of the MDR text. Remember that following closely applicable regulatory requirements is also key to ensure compliance with the ISO QMS requirements. MDlaw.eu offers you exactly such a system.
Secondly, the hardest part – collect the documentation and assure the proper content of it.
As BSi, one of the biggest Notified Bodies is suggesting, when preparing the documentation, take your time. Ask if you have any doubt or you need any clarification. Double check the possible interpretations of articles. Only after (1) informing yourself, (2) compiling your documentation, (3) reviewing it and (4) clarifying everything, you should proceed and submit the documents. Therefore, before submitting the documentation, really make sure to follow the above tips and in the meantime, Obelis will be happy to assist you!
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