EU Authorised Representative /
US Agent Services
The CRO Group is an
EU Authorised Representative through our office in Germany. If your
company located outside the European Union is considering CE Marking your
products, you must have an EU Authorised Representative. The CRO Group is
an authorised representative under the IVDD and MDD. The Authorised
Representative is responsible for the following tasks:
- Product registrations within the EU member states
- Filing of MDV Medical Device Vigilance Reports with
applicable Competent Authorities
- Accepting MDV reports from your EU customers
- Registration of clinical investigations within the EU
member states
Our rates are proportional to the size of your company and
the volume of devices exported to EU member states.
For a no-cost, no-obligation EU Authorised Representative
quote/contract,
click here. If your need is urgent, click
here to contact us by phone to request the
quote/contract.
When you contract with The CRO Group for EU Authorised
Representative services, you receive discounts on other CRO Group services
including:
The CRO Group is a
U.S. Agent able to represent your company, if located outside the
USA, before the U.S. FDA. ALL Foreign Establishments whose products
(Biological Products, Devices and IVD's) are imported
or offered for import into the United States MUST register with the FDA and MUST
identify a United States Agent.
The US Agent is responsible for:
- Maintaining a physical office in the USA
- Updating of
your company's manufacturing facility registration
and product listing
- Providing communications between the FDA and
your company such as advance notice of GMP/QSR inspection
Our rates are proportional to the size of your company and
the volume of devices exported to the USA..
For a no-cost, no-obligation US Agent quote/contract,
click here. If your need is urgent, click
here to contact us by phone to request the
quote/contract.
When you contract with The CRO Group for U.S. Agent
services, you receive discounts on other CRO Group services including:
Some things to keep in mind as you consider The CRO Group
for both EU Authorised Representative and U.S. Agent services:
- We have been working in the medical device and IVD
regulated industries for over 20 years.
- The CRO Group also offers many other related
services at a discount to assist you in marketing
and selling your product in the U.S.A and Europe,
including 510(K) and technical
file / design dossier preparation, GMP/QSR/ISO
compliance audits, clinical study
management, etc.
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