IVDR consulting & CE marking roadmap.
Before any document is written, three regulatory questions decide what your IVDR project will actually cost: how is the device classified, what is its intended purpose, and what evidence is needed to meet IVDR Annex I GSPRs and Annex XIII performance evaluation? FirsTeckBio runs a structured Gap → Strategy → Roadmap → Notified-Body assessment that grounds the answers in IVDR 2017/746, MDCG guidance and Common Specifications 2022/1107.
The IVDR challenge
Why most IVD manufacturers now need structured regulatory support to reach or stay on the EU market.
- Risk-based classification: IVDR Annex VIII rules reclassify devices into classes A, B, C and D — most now require a notified body, unlike the old self-certification under the IVDD.
- Heavier evidence burden: Technical documentation must demonstrate scientific validity, analytical and clinical performance under Annex XIII.
- Limited notified-body capacity: Notified-body bottlenecks make early classification and a realistic timeline essential.
Our consulting services
Strategy and hands-on support across the conformity-assessment journey — engaged individually or as a bundle.
- Regulatory strategy & gap analysis: Gap analysis against IVDR, classification advice and selection of the conformity-assessment route for your device.
- Technical documentation: Preparation and review of IVDR Annex II & III technical files — design dossier, GSPR checklist, risk management (ISO 14971), IFU and labels.
- Notified Body interaction: Notified-body selection assistance and preparation for conformity assessment and audits.
- UDI & EUDAMED registration: Unique Device Identification assignment and EUDAMED actor, device and certificate registration.
- US FDA pathways: 510(k) and related US compliance routes for manufacturers targeting both the EU and US markets.
Quality Management System
A compliant QMS is the foundation of CE marking and a recurring notified-body expectation.
- ISO 13485:2016: Implementation, gap assessment and audit-readiness support for IVD manufacturers and their EU operations.
- Document control: Procedures, records and design-control structures that withstand notified-body scrutiny.
- Audit support: Preparation for certification, surveillance and MDSAP-style audits.
Why FirsTeckBio
Three things that change the outcome of an IVDR engagement.
- Italy-based, EU-qualified: Italian legal address and PRRC-eligible team — your registered EU Authorized Representative without a third-party intermediary.
- Real IVD workflow understanding: Our regulatory work is grounded in real laboratory workflows, sample handling and instrument integration. The protocols we write are executable in clinical labs, not theoretical.
- Pre-NB pressure-test: Before the technical file leaves your desk, we stress-test the classification, the GSPR mapping and the performance plan — to catch the issues that delay notified-body submissions.
Discuss your IVDR pathway
Tell us your device category and current stage. We will frame the classification, documentation and conformity-assessment route, with a realistic timeline.
Request a gap memo