Digital MedTech Roundtable 2026.
- Konferenz
- Virtual Classroom
- Zurzeit keine Termine
- 3 Unterrichtseinheiten
- Teilnahmebescheinigung
Practical forum: Compliance by Design & PFAS Regulation – current challenges in medical technology discussed live!
The EU Packaging Regulation (PPWR), which came into force on 11 February 2025, and the PFAS limits that will apply from August 2026 pose considerable regulatory challenges for medical technology manufacturers. Unclear responsibilities between Development, Regulatory Affairs, Purchasing and Packaging Engineering as well as a lack of transparency in the supply chain harbour the risk of hidden non-compliance, which can lead to delays in product approvals, post-authorisation procedures or significant budget burdens due to redesigns.
Prepare your company specifically for this by identifying critical substances and suppliers and implementing proven best practices from the value chain.
As part of the Digital MedTech Roundtable, we will explain specific pitfalls that jeopardise packaging and product strategies - such as exceeding PFAS limits in blister packs or films that could compromise sterile barriers or recyclability. You will gain practical insights into how agile methods such as Design for Six Sigma, the Lean Progress Model and early risk analyses can systematically minimise these risks.
The roundtable offers interactive sessions, breakout rooms and networking opportunities to avoid supply interruptions, regulatory sanctions or market launch delays in the long term.
Nutzen
- The roundtable offers an optimal mix of current regulatory trends, practical know-how and solutions from experts across the value chain.
- Proven experts from notified bodies, manufacturers and suppliers will prepare up-to-date information on compliance by design, PPWR and PFAS regulation, as well as solutions.
- Best practice examples and open discussions give you the opportunity to adapt successful approaches to your strategy.
- In breakout rooms, you can explore the topics in greater depth with experts and other professionals from your industry.
Zielgruppe
This event is aimed at:
- Manufacturers, suppliers and service providers of medical devices
- Start-ups and innovators in medical technology
- Employees of notified bodies and authorities
- Healthcare providers and hospital administrators
- Quality assurance and risk management experts
- Environmental and sustainability experts
- Legal and compliance officers
Inhalte
- 2:00 p.m.: Opening
Welcome by TÜV Rheinland Academy and moderation by regular services rs GmbH.
- 2:10 – 2:50 p.m.: Topic 1 – Compliance by Design
Agile development under regulatory requirements. Speaker presents challenges, best practices (Design for Six Sigma, Lean Progress Model), cyber security & digital architecture, and success factors.
Speaker: Bernd Schleimer, Head of Customer Care & Sales Medical by TÜV Rheinland LGA Products GmbH
- 2:50 – 3:00 p.m.: Knowledge check/interaction
Take advantage of this opportunity for a brief interaction to share your opinion and actively participate in the exchange.
- 3:00 – 3:10 p.m.: Short break
- 3:10 – 3:50 p.m.: Topic 2 – PPWR & PFAS Regulation
Packaging as a strategic compliance component. Overview of PPWR (effective date: 11 February 2025), PFAS limits for packaging, practical implications for medical technology manufacturers.
Speaker: Steffen Tümptner; Expert of TÜV Rheinland LGA Products GmbH
- 3:50 p.m. – 4:15 p.m.: Breakout sessions
Use this time for direct exchange with the experts. Ask your questions, discuss current challenges – an opportunity for more intensive dialogue in smaller groups.
- 4:15 – 4:30 p.m.: Conclusion & networking
We will summarise the most important findings and show you concrete next steps: What challenges lie ahead in the coming 12 months? How can you prepare your organisation? You will receive access to the recording and stay connected to our network of experts through feedback and networking.
Hinweise
- For the second and each additional participant from a company, the participation fee is reduced by 50% and amounts to €125 plus VAT for these individuals.
- Following the event, a recording of the digital round table will be available on the after-event website and can be downloaded for four weeks. You also have the option of watching video recordings of individual segments.
- The digital participation format offers you maximum flexibility: you can participate from your workplace or on the go. A stable internet connection and an up-to-date browser are required.
- After the event, you will receive a My-Advice-link for your feedback on the content and format. Your feedback will help us to make future roundtables even more targeted.
- If you have any further questions about the event, technical requirements or registration, please contact christiana.biene@tuv.com.
