EU MDR 2017/745 demands a different kind of CRO. One where the clinical evidence strategy is designed the way regulators expect to see it — from protocol version 1.
EUCROF, Amsterdam 2026. Ranked first among all European CROs for clinical innovation, real-world evidence strategy, and EHDS-aligned data architecture.
Under the MDD, many relied on generalist pharmaceutical CROs. Under EU MDR Article 61, treating a device like a drug leads to protocol rejections.
Most CROs build clinical programs and adapt them to regulators. Because our team includes former Notified Body reviewers from TÜV SÜD, we know what assessors look for—and we design programs to pass scrutiny from day one.
The result is clinical evidence that withstands scrutiny because it was designed by people who once performed that scrutiny professionally.
Founded Eclevar MedTech to bring the regulatory perspective inside the CRO model — eliminating the gap between what manufacturers submit and what assessors expect.
Former Senior Reviewer at TÜV SÜD. Expert in Class IIb and III implantable device clinical evidence and Annex XIV compliance.
Generic CRO experience is not sufficient. Each therapeutic area has specific Notified Body expectations. Our teams are structured by vertical.
No outsourcing. Clinical ops, medical writing, and data management by one integrated team.
In-house clinical research associates. Geographic coverage built for EU-Japan PMDA corridors, MHRA post-Brexit pathways, and multi-country European investigations.
