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.
In order to ensure sterility, knowledge of the levels and types of contamination in used surgical instruments is a primary requirement. Sterility is determined by
Product Recall; It is a voluntary withdrawal or recall from the market by the manufacturer of the device for technical and medical reasons, depending on
Stress (tension) is one of two measurable engineering quantities important in understanding the durability or fatigue life of a product. Surgical power tool systems are
Errors resulting from the cleaning process of surgical power tool systems not only pose risks to the patient. Users also have losses. In this article,
Surgical Power Tool Systems are devices that complete their preparation for use by sterilising at 135 degrees due to their area of use and design.
