MDR 2017/745: Seize the Transition Period Now to Develop Innovative Medical Devices
Take advantage of the MDR transition period to develop innovative, MDR-compliant medical devices – with user-centered design and development by Eckstein Design.
MDR 2017/745
Now’s the Time: Use the Transition Period for Innovation in Medical Devices
Why Now Is the Perfect Time for New Product Development
The current transition period under the EU Medical Device Regulation (MDR 2017/745) provides medical device manufacturers with more than just time to update existing devices – it offers a unique opportunity to drive innovation through user-centered medical design and industrial design. Now is the time to initiate new product development that meets MDR requirements and delivers market-ready, patient-focused solutions.
Those who seize this moment can align regulatory requirements with strategic innovation and turn the MDR transition period into a competitive advantage. At Eckstein Design, we combine medical design for regulated products with usability engineering and integrated industrial design & engineering – delivering end-to-end solutions that ensure your medical devices are not only MDR-compliant, but also user-centered and commercially successful.
MDR: Turning Regulation Into a Driver of User-Centered Medical Design
The Medical Device Regulation (MDR) introduces stricter requirements for safety, usability, documentation, and clinical evidence. It compels manufacturers to consider the entire product lifecycle – from development through to post-market surveillance.
For forward-thinking companies, MDR is not a barrier – it’s a driver of innovation.
- By using the required updates as a chance to enhance design, ergonomics, and user experience, manufacturers can create certified medical devices that truly perform in clinical environments.
- Early-stage integration of technical and regulatory requirements into the medical design process speeds up certification, minimizes redesign efforts, and positions you ahead of slower-moving competitors
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Strategic New Development Instead of Short-Term Adjustments
Many manufacturers see MDR as a hurdle because existing products need to be modified. However, these very adjustments offer the perfect opportunity to fundamentally rethink both design and technology. A newly designed product that is developed with MDR compliance from the start can save significant resources in regulatory documentation, approval processes, and risk management over the long term.
- Smarter Interfaces: Improve UI/UX for technical workflows to enhance usability studies, streamline clinical trials, and reduce training time and operating errors.
- Ergonomic Redesign: Design housings, controls, and user interfaces to enhance usability, increase clinical efficiency, and reduce the risk of user error in fast-paced healthcare environments.
- Design for Verification: By embedding MDR compliance into the early stages of development, you can streamline approvals and avoid expensive redesigns later on.
Turning User-Centered Design into a Competitive Edge
The MDR places the user perspective at the core of medical device development: validated usability tests, risk assessments in the context of use, and clear instructions for use are mandatory. Companies that go beyond the minimum requirements and actively invest in user experience can gain a significant competitive advantage
Insight: Clinically intuitive products with lower risk profiles gain faster acceptance among medical professionals and perform better in the market.
Now Is the Time: Leverage the MDR Transition Period
The current MDR transition period until 2027/2028 (depending on product class and certification) provides manufacturers with a valuable time window to:
- Revise existing products to meet MDR compliance requirements
- Develop new products with an integrated MDR strategy
- Establish usability and design processes as core elements of regulatory compliance
Eckstein Design: Expert Partner for MDR-Compliant Medical Device Development
As a design and development agency with expertise in medical design, UI/UX for technical applications, and industrial design & engineering, we support medical device companies throughout the entire MDR-compliant design process – from the initial idea through usability studies according to EN IEC 62366-1 and risk management in line with EN ISO 14971, all the way to series production readiness.
Our approach combines design, ergonomics, user-centered thinking, and regulatory requirements to create market-ready products that deliver real value to both healthcare providers and patients.