With the new MDR (EU) 2017/745 EU Representatives have greater responsibilities and take on significantly more risk and liabilities.

If your business is based outside of Europe and you manufacture a medical device intended for sale in Europe, it is a legal requirement to appoint an EU Representative for medical devices.

Your European Authorized Representative provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.

They are therefore responsible for:

• Ensuring that you comply with the new EU Medical Device Regulations, MDR 2017/745 or IVD Regulation 2017/746
• Interfacing with notified bodies and Competent Authorities on your behalf as required by the MDR
• For ensuring that each medical device or product portfolio complies with the appropriate regulations before being placed on the market in Europe
• As aEU Representative, we are legally responsible for ensuring that devices placed on the European market comply with all requirements of the new Medical Device Regulation (MDR 2017/745).

Many medical device manufacturers do not have offices in the EU. This is a problem as all such EU-based companies must have an Authorized Representative in the EU for regulatory compliance purposes.

The EU Authorized Representative acts on behalf of the manufacturer and is responsible for dealing with requests from the Competent Authority, including handling any safety issues that arise.

If you are looking for a reliable and professional European Authorized Representative, I3CGLOBAL Team can help you.

As your EC Rep, we will:

• Ensure your product complies with all applicable European Directives and Regulations.
• Maintain up-to-date contact details of your company to ensure Competent Authorities can make contact with you at all times.

• Provide access to our team of experienced Regulatory Advisors who will be happy to answer any questions you may have about CE-marking or your role as an EU Representative with FDA Registration.

For more information, please contact the I3CGLOBAL Team: