Device registration in Europe is product classification depended and all the devices must be correctly classified before choosing the marketing procedure for a particular device. Before exporting a device in Europe it must be CE certified.
CE certification of Class I device
Class I devices with non measuring function and non sterile need to be CE certified through self certification process. Manufacturer has to prepare a technical file including declaration of conformity.
In this case Involvement of a Notified body if not required but manufacturer needs to register his medical devices with the competent authority of the country.
IF the manufacturer is Non European then he also needs to appoint an EAR ( European Authorized representative).
Class I devices with measuring function and which are sterile needs to be CE certified with the involvement of the Notified body.
Requirement to appoint an EAR remain changed but there is no need of registering the medical devices with competent authority.
Class II & III
All the class II and III medical devices need to be CE certified with the involvement of a Notified body.
Manufacturer needs to submit a technical dossier with the notified body comprising all the product related information from manufacturing till product release and even post market activities.
If the manufacturer is non European then he needs to appoint an EAR who on his behalf communicates with the notified body for the CE process.
Prior to exporting a Medical device in US it must be registered with US FDA .The device must be first correctly classified for choosing its regulatory path. The categories remain the same (class I, II & III) but classification criteria of US slightly differ from that of EU. Whether a device is 510 k exempt or not depends upon the classification of the device.Most of the class I and few class II devices are 510 K exempt, while some class II device required 510 K(PMN) approval. Class III devices required PMA in order to be placed in US.
Devices Registration of 510 K exempt Products
Devices which are 510k exempt needs to be registered and listed with FDA. Before registration the annual registration fees has to be paid.
Manufacturer not residing in US needs to appoint a US Agent in order to register his devices with FDA.
After registering the devices with FDA the facility is subjected to random FDA audit so it is necessary that your products comply with all the regulations as applicable to it.
Devices Registration of 510 K Products
For devices which are not 510 k exempt it is required to obtain a 510 k clearance for the device and then only the product can be listed on the FDA site.
There are two individual fees for each 510 k approval and product registration & listing. Both fees are revised each FY and the Fee information is updated on FDA site.
Small business can apply for a reduced 510 K review fee but there is no reduction in registration & listing fees.
If you are exporting your class I self certified medical device in Ireland that we can help you in registering your devices with Ireland competent authority.
You just need to appoint Med device as your European representative and we will register all you devices with HPRA..
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Thank you Meddevices! They have tackled all aspects of my CE case in a very short period of time. They are by far the best team I have worked with..
I wouldn’t think of facing an FDA audit without Meddevices’s Assistance..
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