Our Services

You are a manufacturer of MD/IVD, located outside of the EU

You have to establish a contract with a competent and reliable Authorised European Representative (EAR)

EAR’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation. Learn more about EU Regulations (Articles 11 & 15 of MDR).

According to the new regulation, we advise and assist Manufacturers in the relationship with:

Notified Body (NB)
National Competent Authorities (NCA)

of the EU Member States where your products are marketed

We can also advise and assist you to:

Identify the UDI
Perform declarations

to perform declarations for putting on the market your products in each Member State of the EU

Document the EUDAMED Database
Manage the Post-Market Surveillance (PMS)

and vigilance

We can assess the compliance of your:

Technical Documentation
Quality Management System

At your request, we can advise and assist you:

For the Constitution
of your Technical Documentation
On the Choice of a Notified Body
During the CE marking process or audits of your NB
If there is a problem to be solved with your NB or an NCA

TNA & Partners, as your EAR, provides you with the necessary human resources and competencies to comply with the new obligations

will be pleased to be your EAR