Do you want to launch a Medical Device or IVD on the EU market?
Are you planning to enter the EU market?
Do you want to obtain a CE Marking to sell your device in Europe?
EU Authorised Representative – medical devices and in-vitro diagnostics
MDR/IVDR Article 11 states that companies that want to sell their medical devices or IVDs in Europe must either have a physical location in Europe or appoint an Authorized Representative (also known as an EC REP or AR) to represent the company to European authorities. Are you prepared?
Contact IMed’s sister company in Ireland for EU AR services.
IMed can act as your EU AR providing:
- The required liaison between you and the national Competent Authorities (Ministries of Health)
- Support with registration of devices
- Upon request, provide your Technical File or CE Declaration of Conformity for inspection by a Competent Authority
- Support you with Incident and Field Safety Corrective Action (FSCA) reporting
- All-round EU Regulatory support
As your representative with Competent Authorities, your EU AR plays a key role in the success of your products, so selecting someone you can trust is critical.
Many distributors currently acting as EU ARs are already tied up in pre-existing relationships and contracts so you may wish to choose someone independent of distribution or import, to ensure your market access is unhindered.
Selecting IMed Ireland as your EUAR ticks both of these boxes.
But IMed is not just a key partner and EU AR, we are a business partner that shares your objectives and really gets to know your needs. Your success is our success, so please contact us now on 01295 724286 or email us at firstname.lastname@example.org.
Let us get to know your needs and help you get your products into the EU market fast and compliantly.