IVDR Strategy & Gap Analysis
Review the intended purpose, device classification and existing evidence to define the conformity assessment options. The work identifies gaps, priorities and documentation needs for the next stage of the project.
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 regulatory starting point
Share the device type, available documentation and target market so we can agree the review scope.
Discuss gap analysis