Structured Dialogue with TÜV SÜD
Structured Dialogue
The purpose of a structured dialogue prior to lodging a formal MDR/IVDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.
Our clinical experts are available to discuss clinical questions about Cardio, Software, Ophthalmology, Neuro and ENT, Orthopedics and Annex XVI during pre-application and application stages. Our clinical team comprises 40 experts who cover a wide range of medical specialities. We are a diverse global team with extensive experience in MDR/IVDR. Together with internal experts in other assessment areas, we can provide a complete in-house assessment and certification of your medical device.
These structured dialogues are independent of the assessment and can take place even before the application for a conformity assessment. While structured dialogues may not include consultancy services, they can be very useful to enhance the efficiency and predictability of projects before and during the conformity assessment process, as well as to clarify specific product related unclarities (MDCG 2022-14).
Examples of topics for structured dialogue:
1. Application & Onboarding
- Application forms & review process
- Sites, suppliers & devices
- Device classification & code assignment
- Required level of (clinical) data for specific products and devices, needs for clinical investigations
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
- Device-specific approaches and possible regulatory pathways for clinical evaluations
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
- Understanding deficiencies to manufacturers based on the MDR/IVDR requirements that notified bodies have to fulfill
We ensure that you stay ahead of every change!
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