ProductLife Group at MEDICA 2025 turning ideas into adoption with concrete paths for MedTech and IVD

During this year edition of MEDICA (in Düsseldorf from 17 to 20 November, 2025), ProductLife Group has been on site meeting manufacturers, importers and distributors to address a shared priority across MedTech and IVD: turning plans into credible approvals, real market uptake and compliant lifecycle management. Discussions on the floor confirm that progress depends on linking regulatory, clinical, quality and market access so strategies advance without friction and remain inspection ready 

Conversations at the fair confirm a few cross-cutting priorities: completing MDR and IVDR transitions, strengthening clinical and performance evidence, managing the full device lifecycle, and preparing for access and reimbursement across countries. In parallel, attention continues to grow on traceability with UDI and EUDAMED, vigilance and PMS or PMCF, inspection-readiness of documentation and alignment with Notified Body expectations. 

For companies the question is not if approval is achievable, but how to reach it in a repeatable and sustainable way across multiple markets. This is where an integrated approach makes the difference, connecting regulatory, clinical, quality and market access to reduce uncertainty, shorten timelines and support adoption. 

The value PLG brings to these discussions comes from combining complementary capabilities: 

• Regulatory and Quality: MDR and IVDR strategies, preparation and maintenance of technical documentation, interactions with Notified Bodies, ISO 13485 QMS, UDI and EUDAMED, vigilance, PMS and PMCF, change control and post-market maintenance. 

• Clinical and Evidence: clinical and performance evaluation plans, aligned with IVDR requirements and sound methods, with evidence generation that supports both regulatory progress and adoption. 

• Market and Patient Access: pathway mapping, pricing and reimbursement inputs, and support for national assessments with strong and transparent value narratives that resonate with payers and clinicians. 

• Representation services and international network: coordinated entry and growth across markets, with aligned timelines, documentation and engagements. 

This setup enables a smooth path from strategy to day-to-day delivery while keeping programmes inspection-ready, aligned with standards and prepared to scale across countries. 

• MDR and IVDR transitions: realistic roadmaps that close documentation and methodological gaps, with evidence that is fit for purpose and avoids over-engineering that slows progress. 

• Inspection-readiness and dossier governance: clear documentation structures, metrics and versioning that support efficient audits and interactions with NB and Authorities. 

• PMS, PMCF and vigilance: pragmatic plans, proportionate data collection and feedback loops that power maintenance and improvement. 

• Access and reimbursement: linking evidence early to HTA, pricing and reimbursement needs to avoid late rework and delays to access. 

• International expansion: common frameworks reused across countries with targeted adaptations to requirements, available data and stakeholder priorities. 

Many companies need support for: 

• IVDR plans with performance evaluations that are proportionate and defensible 

• post-market maintenance that unites PMS, PMCF, vigilance and regulatory updates 

• technical files that are ready for review with clear rationale, traceability and defined controls 

• market access strategies coordinated across countries with local insight and a value language that payers and clinicians understand 

PLG’s operational experience turns principles into procedures. In practice this means: 

• defining common methodological structures that can be adapted locally 

• making assumptions and requirements explicit and transparent 

• assigning metrics and responsibilities to every phase 

• maintaining continuity across regulatory pathway, post-market and access so each update strengthens the whole rather than fragmenting it 

Pressure on compliance, timing and sustainability will continue to increase. This is why we invest in models, skills and partnerships that help teams prepare earlier, linking evidence, regulatory needs and access pathways from the start. The goal remains constant: turn plans into reliable approvals, adoption and coherent maintenance, with concrete benefits for patients and health systems.  

If you are interested or would like to learn more, contact us.