Regulatory Affairs
qtec EuRep GmbH
Manufacturers based outside the EU must appoint an authorized representative within the EU if they wish to place products on the EU market.
Triggered by market surveillance activities, the competent authorities often first contact the importer of a Medical Device from a non-EU manufacturer. At this point, it is critical for the importer to have a qualified and assisting contact at the manufacturer's authorized representative who can handle this communication.
A new generation of authorized representatives
In the future, authorized representatives are no longer just vessels for documents, they are now expected to serve as a partner for not only the manufacturer, but also the importers of Medical Devices. Manufacturers must take caution when choosing an authorized representative; it is vital that they take great care in their decision, as the right authorized representative can be a great help, whilst one that does not can be the downfall of the company. They are expected to withhold the trust of the market participants.
The qtec EuRep GmbH
The qtec EuRep team as a part of qtec itself, is composed of 85 plus experts and are responsible for all areas of medical technology. With this they make sure that :
- You are constantly informed of all new requirements / norms, and rules and regulations.
- You are offered targeted and competent assistance, when filling in any gaps in your Technical Documentation.
- That schoolings and expert statements pertaining to regulatory questions or design control topics such as risk management of Validation, or Usability are taking place.
- That your Clinical Evaluation is created by savvy experts that support your Post Market Surveillance activities.
- Properly advise you in choosing your partner in the european or international market.
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