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Guide · Running a clinical trial in Spain · Real Decreto 192/2023 How to run a medical device clinical trial in Spain. Spain runs under
Guide · Running a clinical trial in the UK · UK MDR 2002 How to run a medical device clinical trial in the UK. Since
Insight · Market access · Germany How the G-BA, NUB and Paragraph 137h decide whether your device gets paid. Germany is the largest medical device
Insight · EU MDR · Japan-EU corridor From Japan to the EU: taking a device into Europe without restarting the evidence. A device approved in
Insight · Market Access · France CNEDiMTS: how France decides whether your device gets reimbursed. A CE Mark lets you sell a device in France;
Registry PMCF · Orthopaedic Implants · EU MDR Registry-based PMCF for orthopaedic implants. A short read on using the NJR and EPRD to build post-market
Insight · Clinical Operations · Italy How to Submit a Device Clinical Trial in Italy: Ministry of Health, Ethics Committee and Decreto 137/2022 Submitting a
Insight · Clinical Operations · France How to Submit a Device Clinical Trial in France: ANSM, CPP and the Jarde Framework Submitting a device investigation
Insight · Clinical Operations · United Kingdom How to Submit a Device Clinical Trial in the UK: MHRA, HRA and REC Submitting a device clinical
European CRO · EU MDR · ISO 14155 · Device clinical trials Outsource your device trial to one accountable European partner. Under EU MDR your
Insight · Clinical Operations · ISO 14155 CRO Clinical Monitoring Under ISO 14155: What Good Practice Looks Like Monitoring is where a clinical investigation either
European CRO · EU MDR · ISO 14155 · Device clinical trials Outsource your device trial to one accountable European partner. Under EU MDR your
Medical Device CRO · France · EU MDR · ANSM & CPP · CNEDiMTS One study for France, CE marking and reimbursement. France is Europe’s
Sweden & the Nordics · EU MDR · Läkemedelsverket · registries Your MedTech CRO in Sweden and the Nordics, one EU MDR programme. The Nordics
Insight · EU MDR · Orthopaedics Orthopedic implant CERs under MDR, when market history is no longer enough. For decades, an orthopaedic implant’s long, clean
Insight · EU MDR · WET Device List MDR update of the WET device list: what the 2026 delegated regulation means for your clinical evidence.
Insight · EU MDR · Wound Care Clinical Evaluation Reports for wound dressings: when claims, classification and evidence no longer match. Wound dressings were, for
Insight · EU MDR · Cardiology CER Clinical Evaluation Report Cardiology: how to secure your CER before it blocks CE marking. For a cardiac device,
Medical Device CRO · Italy · EU MDR · D.Lgs. 137/2022 Your MedTech CRO in Italy, built to Ministero della Salute expectations. Italy is the
Buyer guide · EU MDR · 2026 How to select a medical device CRO in Europe, in 2026. Choosing a CRO for a device is
Exclusive Whitepaper Mastering EU MDR Clinical Evidence with BSI & Eclevar. Co-authored by BSI Group and Eclevar MedTech. Discover how to align your clinical evaluation,