Our Vision & Mission
The most important aspect of our business is to represent both your company itself and its regulatory affairs interests within the European Union. Our expertise will ensure that you remain in full compliance with EU legislation at all times.

Customer satisfaction is the essential driver in our daily business. We continuously ask our clients what they need from us – our clients directly influence our range of services and products on offer. Each client is unique and different – mdi Europa customizes an individual solution for each one.

We help you to develop and implement cost-effective strategies and programs to meet the European requirements for your specific medical device and business objectives.

Our Aims
1. Your full compliance with EU legislation
Our aim is to continually provide you with as much European Regulatory Affairs information as possible. With us, you will not miss any news or changes in EU legislation.

2. Your satisfaction
By offering a telephone-hotline, we ensure that you can reach us whenever needed. All email or fax correspondence will be replied to within 24 hours. We will not only keep you informed on regulatory changes – we will explain step by step what needs to be done to remain in compliance.

3. Quality Management
Our internal Quality Management System has been certified to ISO 9001:2000 in December 2005. This will allow you to prove to your Notified Body and to authorities around Europe that your European Vigilance System is running under controlled and certified conditions.

Overview: Responsibilities of an EU Authorized Representative
Definition of MDD and IVDD:
“authorized representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.

This is how the European medical device Directives define the duties and responsibilities of an Authorized Representative. Obviously, the text of the Directives serves as the basis for our daily work. But we do more:

We will be your European Regulatory Affairs representation. As such, we will be responsible towards the EU competent authorities that you, the manufacturer, fulfill all duties and responsibilities as stipulated by the Directives.

The EU authorities will not correspond with non-European manufacturers directly. All contacts and correspondence with regards to your company and your devices will go via your European Regulatory Affairs Representative, mdi Europa.

The name and address of your European Authorized Representative must be shown on your labeling, packaging or instructions for use. As a result, various parties from all over Europe will contact us, when they have queries or questions regarding your devices. This means, we will be in constant communication with your distributors, end-users, customers, etc.

mdi Europa will take care of all necessary reporting, registration and communication with European authorities and bodies – to the right person at the right time, every time. The Directive also requires that the European Authorized Representative holds a copy of the manufacturers Technical File and a register of product complaints in Europe.

Independently owned and operated, mdi Europa ensures the elimination of every possible conflict of interest with regards to confidential trade or product information.
We guarantee the highest level of professional confidence and courtesy at all times. This is confirmed in our standard service contract, or – at your request – by signing a separate Confidentiality Agreement with you.

Why you should not appoint your Distributor as Authorized Representative?
1. Regulatory Compliance
An Authorized Representative will be responsible for verifying your compliance with the applicable conformity assessment procedure as well as the correct classification of your devices.
Your Authorized Representative will have detailed knowledge of all the individual regulations of each of the 27 EU member states.

2. Technical File
Your Authorized Representative will have to retain a copy of your Technical File and must allow the competent authorities of all 27 member states access to that information and data.

3. Incident Reporting & General Surveillance
Your Authorized Representative will be aware of incidents in all EU member states. He will handle sensitive product information, like European market information, distributor lists etc.
An Authorized Representative may be required to make decisions that are contrary to a distributor’s interests, such as product recalls. As such, the Authorized Representative must be able to decide fully independently and to your best regulatory interests at all times.

4. Independence & Neutrality of your Authorized Representative
An Authorized Representative must remain neutral in all actions, including being neutral towards possible competitive Distributors.

5. General
One should be aware of the inherent risk in appointing one of your European Distributors. This practice will inevitably lead to a hierarchical situation amongst your Distributors, those not appointed as Authorized Representative would perceive themselves as less significant, especially as only the Authorized Representative’s name appears on the labeling.
As it is a legal requirement to include your Authorized Representative’s details on your labels and packaging, changing your Authorized Representative is expensive, inefficient and cumbersome. It involves the reprinting of labels and packaging with the new Authorized Representative’s details, as well as scrapping of all printed stock on hand. It is strategically prudent to appoint an independent representative at the outset thus avoiding unnecessary complications, expense and discontentment later.
Appointing a Distributor as Authorized Representative can cause a serious conflict of interest for you in the European market. Please bear that in mind when deciding who to appoint as your Authorized Representative.