The Nordics pair well-organised healthcare systems with a deep research culture and some of the most complete patient registries in the world. We design one EU MDR protocol across Sweden, Denmark, Norway and Finland, with Läkemedelsverket and ethics submissions, registry integration and in-house Swedish CRAs.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar for clinical evidence across Sweden and the Nordics. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that reads the Nordics as one coordinated EU MDR problem rather than four separate markets. We build a single protocol that runs across Sweden, Denmark, Norway and Finland, integrate national quality registries such as Swespine into the PMCF plan, and monitor with in-house Swedish CRAs rather than outsourced staff.
The Nordic countries combine high-quality, well-organised healthcare systems with a deep culture of clinical research and some of the most complete patient registries in the world. That structure supports MDR clinical evidence, PMCF and long-term real-world follow-up when it is designed in from the start.
Some of the world's most complete national patient and quality registries, such as the Swespine spine register, are ideal anchors for PMCF, long-term outcomes and real-world evidence.
Strong cultural and infrastructural alignment with source-data integrity and audit-trail standards, so datasets stand up to Notified Body and competent-authority scrutiny.
High English proficiency and mature digital healthcare infrastructure mean low friction for international sponsors setting up and running studies.
Well-organised academic and hospital centres support multi-country studies, with efficient ethics review through the Swedish Ethical Review Authority.
Two Swedish authorities govern device clinical investigations within the EU MDR framework. We manage both submissions and keep them aligned with your EU MDR regulatory strategy.
The Medical Products Agency (Läkemedelsverket), the Swedish Medical Products Agency, is the competent authority for medical device clinical investigations under EU MDR 2017/745.
The Swedish Ethical Review Authority handles ethics review, with an efficient, well-organised process that supports multi-site and multi-country studies.
Both submissions operate inside the EU MDR framework, so a Swedish study feeds directly into your technical documentation and CE file.
We treat the Nordics as one coordinated strategy rather than isolated markets: one protocol, harmonised sites and registry integration designed in from the start, so a single MDR study serves clinical evidence, PMCF and real-world follow-up together and streamlines ethics and monitoring across the region.
A full-service Nordic CRO offering, from feasibility to post-market surveillance, with registry integration where it adds the most value.
Nordic registries provide revision, survival and outcome data at a scale and completeness few other regions match. We integrate them into your PMCF plan from the outset.
One EU MDR protocol scoped across Sweden and the Nordics.
Läkemedelsverket and Swedish Ethical Review Authority submissions.
Feasibility, site selection and registry integration designed in.
Harmonised sites monitored by in-house Swedish CRAs.
Registry data feeds the CER, PMCF and PSUR over time.
The Medical Products Agency (Läkemedelsverket), the Swedish Medical Products Agency, is the competent authority for medical device clinical investigations, with ethics review by the Swedish Ethical Review Authority (Etikprövningsmyndigheten), operating within the EU MDR 2017/745 framework.
The Nordic countries combine well-organised healthcare systems, a deep clinical research culture and some of the most complete national patient and quality registries in the world. That makes them a strong fit for EU MDR clinical evidence and long-term PMCF, especially when designed as a coordinated regional study rather than isolated markets.
Yes. A single EU MDR protocol can run across Sweden, Denmark, Norway and Finland with harmonised sites, which a regional CRO coordinates to streamline ethics submissions and monitoring.
Yes. National quality registries such as Swespine provide long-term revision and outcome data that, integrated into a PMCF plan, become quantitative real-world evidence for the Clinical Evaluation Report and the PSUR.
Yes. Eclevar deploys in-house Swedish CRAs, so site initiation, ethics submissions and monitoring across the Nordic hospital network are handled by our own team rather than outsourced.
Talk to our team about your device, your Nordic sites and how to anchor PMCF in Swedish quality registries under EU MDR. Compare it with a UK market access route if you need both.
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