How does the design of surgical power tool systems work?
This blog is intended as a brief introduction for orthopaedic surgeons on how the design of surgical power tool systems works in factories. When producing
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All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products within EU countries. This representative plays a role as a bridge between the authorities and the manufacturer according to MDR Article 11 Authorised Representative.
Manufacturer and AR should are required to come together and sign an agreement (mandate) explaining their tasks. All the tasks need to be clarified and all the informations should be provided in case of any representative change in this agreement. AR should perform the tasks of this agreement and comply with the registration obligations (EUDAMED).
For the full regulation click here.
What are the duties of AR?
Do you know how to prepare the content of the Technical File according to new MDR? Click here to get Technical File structure.
How to register in EUDAMED as a Non-EU manufacturer and get Single Registration Number (SRN)?
Manufacturer submits its actor registration request to the Authorised Representative. But first things first, AR should be registered in EUDAMED as an economic operator before your registration. After you check that your AR is registered, AR need to verify this request before transmitting this request to the authority in this phase. If everything all right, AR forwards your actor registration request to the authority via database.
The competent authority has three decisions upon this request.
Find the EUDAMED Mandate Summary sample document at this link.
You can follow these instructions in the video below while you submit your request
If you want to change your AR, you should sign a new agreement with the incoming AR and you should indicate following aspects in it:
Do you know what are the Vigilance Requirements of MDR? Click here to learn how to prepare the needed documents such as reporting of serious incidents.
This blog is intended as a brief introduction for orthopaedic surgeons on how the design of surgical power tool systems works in factories. When producing
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