URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH

Their core work

Poland's national competent authority for the registration and market surveillance of medicinal products, medical devices, and biocidal products — the Polish equivalent of a national medicines agency. In EU-funded projects they contribute the regulatory authority perspective: what evidence standards are required for market approval, how clinical investigations should be designed, and how device registries should be structured to satisfy regulators. Their value in a consortium is institutional: they represent how a real national authority reads evidence submissions, which is knowledge that researchers and manufacturers cannot get from academic partners alone. They also participate in shaping pan-European regulatory science frameworks through multi-country coordination actions.

What they specialise in

How they've shifted over time

Their first project (STARS, 2019) focused on broad regulatory science capacity-building — how to train university researchers to engage with regulatory processes. By 2021, their focus had sharpened considerably: CORE-MD placed them inside the specific challenge of generating clinical evidence for high-risk medical devices, with concrete clinical domains (cardiology, orthopaedics, diabetes) and methodological concerns (trial design, registries, evidence standards). The shift is from regulatory science as a discipline to medical device regulation as a specialisation, driven by the EU Medical Device Regulation (MDR 2017/745) coming into full force during this period.

They are deepening into the clinical evidence and registry infrastructure questions that define the EU MDR era — a direction that will keep them relevant as device manufacturers struggle to meet new post-market clinical follow-up requirements.

How they like to work

They participate exclusively as consortium partners, never as project coordinators, which is typical for national regulatory authorities: they lend legitimacy and practical knowledge of approval processes rather than managing research programmes. With 41 unique partners across just two projects, they operate in large multi-stakeholder consortia — the kind of broad coordination actions that need a regulator at the table. There is no evidence of repeated partnerships, suggesting they join topic-driven consortia rather than maintaining a fixed network of collaborators.

Forty-one unique partners across 19 countries from only two projects indicates participation in large, pan-European CSA consortia that deliberately assembled diverse national authorities and research institutions. Their network is broad but shallow — many partners, no evident anchor relationships.

What sets them apart

As a national competent authority, URPLWMIPB brings something no university or industry partner can provide: the institutional perspective of a regulator who actually decides whether products reach the market. In consortia developing clinical evidence frameworks or device registry standards, their presence signals to other regulators and to the European Commission that the output has been shaped by real-world approval practice. For any project operating in the EU MDR or IVD Regulation space, having a national authority as a named partner substantially increases credibility with reviewers and end users.

Highlights from their portfolio

• STARS
  Largest funding received (EUR 53,250) and the foundational project establishing their H2020 presence, focused on bridging academia and regulatory bodies through training in regulatory sciences.
• CORE-MD
  Directly addresses the most contested area in EU medical device policy — generating robust clinical evidence for high-risk devices — placing URPLWMIPB at the intersection of regulatory reform and clinical practice across cardiology, orthopaedics, and diabetes.