For MedTech manufacturers navigating EU MDR, IVDR, UKCA and global regulatory frameworks, Eclevar MedTech provides the strategic architecture to secure your approvals, built by former Notified Body reviewers.
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 EU MDR strategy and Notified Body engagement. Read all client success stories.
Eclevar's regulatory strategy is built by people who assessed technical files from inside a Notified Body. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that knows what triggers a Major NCR and designs a cohesive regulatory narrative where every document, from the CER to the risk file, reinforces your safety claims.
In the EU MDR era, compliance is no longer a static goal. It is a continuous cycle of clinical evidence generation and risk management. Eclevar does not just fill forms: we architect technical documentation that withstands the most rigorous audits.
The core insight. Most Major NCRs are not caused by a lack of data, but by a lack of narrative alignment. A CER that does not talk to your risk management file, or a technical file that misses the state-of-the-art context, is a red flag. We build a cohesive regulatory story where every document reinforces your safety claims.
Mock-audit against Annex II and III, GSPR mapping and technical writing to close every gap before your Notified Body finds it.
NB liaison, NCR defense, audit support and EC query management, led by former Notified Body reviewers.
Rule 11 software guidance, classification strategy and clinical pathway planning aligned to your intended purpose.
Global regulatory roadmaps with UKCA and PMDA bridging and FDA 510(k)/PMA alignment.
Analysis of existing documentation, clinical data and risk files.
CEP structuring and GSPR requirement mapping.
CER and technical documentation drafting optimised for NB acceptance.
Query management through to certificate issuance.
| Focus area | Old directive (MDD) | New regulation (MDR) |
|---|---|---|
| Clinical evidence | Equivalence default; light data. | Mandatory clinical data; strict equivalence limits (Annex XIV). |
| Technical documentation | Siloed; minimal lifecycle focus. | Unified technical file; dynamic lifecycle integration (PMS/PMCF). |
| NB scrutiny | Sampling audits; predictable timelines. | Unannounced audits; deep technical and clinical review. |
| Post-market | Passive complaint reporting. | Active PMS and PMCF; continuous data collection. |
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any technical file and regulatory strategy.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
Rule 11 has moved almost all software as a medical device to Class IIa or higher. We help you define your intended purpose carefully to secure the correct classification while preparing the rigorous clinical data now required.
Yes. Legacy MDD devices have no grandfathering under the EU MDR. We conduct a gap analysis of your current data and build a clinical bridging strategy to minimise new trial requirements.
Yes. We act as your technical experts during audits and lead the response strategy to Notified Body questions, significantly reducing the risk of a Major NCR.
Talk to our team for a technical file gap analysis, a classification strategy or a Notified Body defense plan built by former reviewers.
Book a strategy call