Medical Device & IVD Clinical Trials
Specialised clinical trial support for medical devices, in-vitro diagnostics, and combination products. MTK delivers end-to-end clinical evidence generation across the full device lifecycle — from first-in-human feasibility studies through post-market clinical follow-up — navigating the distinct regulatory pathways that separate device development from pharmaceutical programmes.
Purpose-Built Expertise for Device Development
Medical device and IVD clinical investigations operate under regulatory frameworks that differ fundamentally from pharmaceutical trials. Risk classification drives study requirements, performance endpoints replace traditional efficacy measures, and post-market obligations extend well beyond initial approval. MTK's device trial specialists understand these nuances and build clinical programmes accordingly.
Our team brings hands-on experience across Class I through Class III devices, active implantables, software as a medical device (SaMD), and companion diagnostics. We partner with manufacturers, notified bodies, and regulatory authorities to design investigations that generate the clinical evidence required for CE marking, FDA clearance, and global market access.
Comprehensive Device Trial Services
Six specialised capability areas addressing the unique requirements of medical device and IVD clinical investigations — from regulatory strategy and study design through post-market surveillance and PMCF planning.
EU MDR / IVDR Compliance
Comprehensive support for clinical investigations conducted under the EU Medical Device Regulation and In-Vitro Diagnostic Regulation, including clinical evaluation report authoring and literature reviews.
- Clinical Evaluation Reports (CER)
- Systematic literature reviews
- Notified body interaction support
- Technical documentation alignment
510(k) & PMA Support
Clinical data strategy and study execution for FDA premarket submissions, covering substantial equivalence demonstrations, premarket approval applications, and De Novo classifications.
- Predicate device analysis
- Clinical study design for clearance
- PMA clinical module preparation
- De Novo pathway navigation
Post-Market Clinical Follow-Up
PMCF study design, execution, and reporting that fulfils ongoing obligations under EU MDR Article 61 to confirm device safety and performance throughout its commercial lifecycle.
- PMCF plan development
- Registry-based PMCF studies
- PMCF evaluation reports
- Periodic safety update reports
Device-Specific CRF Design
Case report form design tailored to device investigations, capturing performance endpoints, usability assessments, implant tracking data, and device-related adverse event reporting fields.
- Performance endpoint capture
- Usability data collection
- Device malfunction reporting
- Implant tracking fields
UDI Integration & Traceability
Unique Device Identifier integration into clinical data systems, enabling complete traceability from manufacturing lot through implantation and long-term follow-up.
- UDI-DI and UDI-PI capture
- GUDID / EUDAMED alignment
- Lot-level accountability
- Explant and revision tracking
Risk Classification & GSPR Mapping
Systematic mapping of clinical evidence to General Safety and Performance Requirements, ensuring every GSPR is substantiated by appropriate clinical data throughout the device lifecycle.
- GSPR checklist development
- Clinical evidence gap analysis
- Risk–benefit determination
- State-of-the-art benchmarking
Navigating Global Device Approval Routes
Each regulatory pathway imposes distinct clinical evidence requirements. MTK's regulatory affairs and clinical operations teams collaborate from the outset to ensure your investigation is designed to satisfy the specific data expectations of every target market.
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EU MDR — CE Marking
Clinical investigations and clinical evaluation strategies aligned with EU MDR Annex XV requirements, supporting notified body review and CE marking across all device classes.
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FDA 510(k) — Substantial Equivalence
Clinical study design demonstrating substantial equivalence to predicate devices, with performance testing protocols and biocompatibility assessment support.
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FDA PMA — Premarket Approval
Pivotal clinical investigations for Class III devices requiring the highest level of regulatory scrutiny, including IDE submission preparation and FDA interaction management.
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FDA De Novo — Novel Device Classification
Clinical evidence strategies for novel devices without a predicate, establishing new regulatory classifications with appropriate performance standards and controls.
Why Choose MTK for Device Trials
Medical device clinical investigations demand a partner who understands the regulatory landscape, the evidence requirements, and the operational realities that distinguish device programmes from pharmaceutical trials.
Device Expertise
Dedicated device trial specialists with deep knowledge of ISO 14155, EU MDR clinical investigation requirements, and FDA device submission pathways across all risk classifications.
Unified Platform
Device-optimised EDC, UDI-integrated data capture, and CTMS modules built into a single eClinical platform that manages every aspect of your clinical investigation.
Global Reach
Multi-country investigation management with local regulatory expertise across the EU, US, UK, and Asia-Pacific markets, enabling parallel submissions for faster global market access.
Regulatory Navigation
Strategic guidance through complex and evolving device regulations, from initial classification and pathway selection through notified body interactions and post-market obligations.
Discuss Your Device Trial
Whether you are planning a first-in-human feasibility study, a pivotal investigation for CE marking, or a post-market clinical follow-up programme, our device trial specialists are ready to help. Connect with us to explore how MTK can accelerate your path to market approval.