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EU MDR Class I Medical Device Updated: 19th July 2020
We have work with clients on CE MDR process for Class I non-sterile, non-measuring, non-reusable. What this means that Manufacturers can do a self declaration that their product is complying to CE (no need to involve Notified Body like SGS, TUV and BSI etc) ! Steps are as below:
- Prepare technical documentation like label, Instruction leaflet, clinical evaluation, risk analysis, testing (CMS can help you)
- Ensure Quality Management System (Good Manufacturing Practice for Medical Device in layman terms) is setup. This means there must be proper written procedure and forms in place (CMS can help you)
- Engage an EC REP. This means if you do not have a company in Europe (CE recognized EU regions) you need appoint a authorized representative. This representative company name would be reflected in your product label (CMS is also an EC REP!)
- EC Rep would register the product in the country where the EC Rep resides
- Finish! And now you can sell your products in Europe and also put CE Marking on your product label!
Please note the EC Rep may request as part of their requirement for access to your share drive and to include them in your product liability insurance.
