Meeting the Requirements of the EU’s Medical Device Regulation (MDR 2017/745)

HOW TÜV SÜD CAN HELP MANUFACTURERS ACHIEVE MDR 2017/745 COMPLIANCE

TÜV SÜD was among the world's first organisations to receive designation as a Notified Body for the European Union’s MDR (Regulation (EU) 2017/745).

With 2 EU notified bodies and more than 750 medical device professionals in more than 30 locations worldwide, we are one of the largest organisations providing certification services under the EU MDR 2017/745.

A. REQUEST FOR MDR SERVICE REGISTRATION

Request assistance with the MDR 2017/745 certification process through our form below or contact us at [email protected].

Request for a MDR service registration today

• For language requirements of documentation submissions, please refer to the respective Conformity Assessment Procedure pages below.

B. Notified bodies conformity assessment PROCEDURE & FAQS

Manufacturers need to apply for a suitable conformity assessment procedure from a Notified Body based on their product classification. You can learn more about TÜV SÜD’s MDR services by visiting the respective TÜV SÜD Notified Bodies webpages on MDR Application Procedure.

• MDR Conformity Assessment Procedure TÜV SÜD PS GmbH
• MDR Conformity Assessment Procedure TÜV SÜD Danmark ApS

You can also find out more information about the EU’s MDR 2017/745 by visiting our Frequently Asked Questions page.

C. STRUCTURED DIALOGUE

The purpose of a structured dialogue prior to lodging a formal MDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.

These structured dialogues are limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the MDR framework agreement.

Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.