Plan early
Build realistic MDR plans before documentation is fully mature.
Talk to our experts about your MDR requirements, certification planning and next steps.
MDR customer success stories
Managing MDR complexity effectively
The Medical Device Regulation places greater demands on technical documentation, clinical evidence, post-market surveillance planning and cross-functional coordination.
For manufacturers with broad portfolios or time-critical projects, the challenge is not only meeting these requirements, but managing complexity before it leads to delays and planning uncertainty.
The hidden MDR risk: late alignment
Incomplete documentation is not the only cause of delays. When requirements, responsibilities, timelines and evidence expectations are clarified too late, regulatory complexity can quickly become a business risk.
Early exchange with your Notified Body can help identify potential issues sooner and create a more predictable path through conformity assessment.
Why manufacturers value stability and continuity
The regulatory landscape continues to evolve.
Manufacturers need more than technical expertise. They need access to experienced teams, broad scope designation, predictable certification processes and a notified body with an enduring commitment to MDR certification into the future.
How TÜV SÜD supports your MDR pathway
TÜV SÜD supports MedTech manufacturers throughout the MDR certification process with:
- Technical expertise across complex medical device portfolios
- Structured regulatory dialogue to align requirements and expectations
- Transparent communication to support more reliable planning
- Conformity assessment services throughout the certification process
KARL STORZ: Managing a broad portfolio through the MDR transition with a reliable team of TÜV SÜD’s experts
KARL STORZ: Managing a broad portfolio through the MDR transition with a reliable team of TÜV SÜD’s experts
KARL STORZ needed to transition a large number of medical devices from MDD to MDR. With a broad product portfolio, the company required a Notified Body with a wide scope of accreditation and designation, together with direct and transparent communication throughout the process. Through structured regulatory dialogue, early alignment and continuous expert exchange, TÜV SÜD supported the complex transition across the portfolio.
Bentley: Improving planning certainty for time-critical MDR projects with a long-term Notified Body
Bentley: Improving planning certainty for time-critical MDR projects with a long-term Notified Body
Bentley had experienced prolonged MDR processing times with its previous Notified Body, creating uncertainty around planning and product availability. As the company noted, “Bentley experienced MDR processing times of up to 33 months with its previous Notified Body and needed a more reliable approach.” With TÜV SÜD, the collaboration focused on reliable timelines, detailed quotations, open communication and a dedicated service model for time-critical projects, helping Bentley plan its MDR pathway and product availability more effectively.
What manufacturers can learn from these MDR journeys
Align teams and expectations
Clarify responsibilities and requirements across teams and with your Notified Body.
Connect MDR to business planning
Consider product availability, portfolio priorities and market plans alongside MDR timelines.