Achieve EU Market Access with TÜV SÜD

APPLY FOR MDR CERTIFICATION NOW BEFORE 26 MAY 2024

On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period to adapt to new rules under the MDR for products already on the market under the MDD/AIMDD.

It’s important to note that the extension of transition period to the new rules is subjected to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:

• This means that the application has to be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD has to be concluded latest by 26 September 2024.

TÜV SÜD continues to strongly encourage manufacturers to act now, despite the new deadlines. The procedure of the EU MDR is known to be complex and sometimes requires longer processing times. TÜV SÜD has, at an early stage and steadily, built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active in the new situation and work at full speed on the planning, to avoid any delays at the end of the transition timelines.

HOW TÜV SÜD CAN HELP MANUFACTURERS ACHIEVE MDR COMPLIANCE

With more than 750 medical device professionals in more than 30 locations worldwide, we are one of the largest EU Notified Body globally authorized to provide certification services under the EU’s MDR.

A. MDR REQUEST FOR SERVICE REGISTRATION

Request assistance with the MDR certification process through our form

B. 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.

Possible topics for Structured Dialogue

1. Application & Onboarding

• Onboarding process
• Application forms & review process
• Sites, suppliers & devices
• Device classification & code assignment

2. Topics of manufacturer

• TÜV SÜD Testing & Certification Regulations
• MDR/IVDR Framework Agreement
• Handling of device and other changes
• Transfer to TÜV SÜD Notified Body

3. Conformity Assessment Procedure

• Project planning, time limits special procedures (e.g. consultation)
• Submission requirements Costs, fees & other financial aspects
• CS, guidance documents & harmonized standards

 

How to apply for Structured Dialogue 

Existing clients with TÜV SÜD Notified Body

• If you are an existing client, please get in touch with your dedicated client manager to move forward

New clients

• If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue process, please fill up the request form

Apply today!