Manufacturers prepare structured regulatory data on CertHub. You engage either by running reviews inside CertHub, or by receiving a digital transmission into your own system. Human judgment stays yours.
Assessment pipeline
Sterilizator 20A · Intake → review → decision
Completeness check
96% · 2 gaps
GSPR mapping
Awaiting validation
Why data-driven assessment
The sources are public. The direction is clear. CertHub connects manufacturers and Notified Bodies on that path — and we do the work with you.
The Commission’s Horizon Health 2025 call states conformity assessment still relies on continuous exchange of complex technical documentation as PDF or Excel. Digitalisation means moving from document to data-driven processes — and we build that path with you, not around you.
Team-NB surveys show incomplete submissions remain common: in October 2025, only 14 of 51 MDR-designated Notified Bodies reported that more than half of submissions were complete before content review. That is public industry data — we use it openly when we design intake with partner bodies.
DIGICAP (CORDIS 101288338), coordinated by TEAM-NB, runs 2026–2029 toward an open framework with structured machine-readable data. CertHub is not a consortium beneficiary. We cite the project because the direction is public — and we already build manufacturer-side structured data and NB transmission with partners who want to move with it.
The Commission has proposed (COM(2025) 1023) that manufacturers may draw up technical documentation in digital form, including structured machine-readable formats, agreed with the Notified Body. That is a proposal, not yet adopted law — we say so plainly, and we prepare the exchange with you before it becomes mandatory.
Why now
Hiring alone will not close the gap. Experienced MDR and IVDR reviewers take years to develop. Added capacity has to come from reviewer leverage.
From 25 February 2027, EU 2026/977 sets binding maximum timelines per assessment phase. From 2028, annual timeline and cost reports must be published. Manufacturers will compare bodies on throughput you can no longer hide — we help you meet the clock with them.
In CertHub’s process model (anchored to NB interview data, pilot validation ongoing), most reviewer time goes to locating evidence across unstructured ZIP archives. Mapping moves upstream so expert time returns to assessment.
AI structures evidence and keeps the audit trail. Findings and conformity decisions stay with your experts. CertHub never takes a conformity decision.
Two ways to work with us
Same manufacturer-side structured data. Two engagement models for the assessment side.
Experts are not the bottleneck. Unstructured files, incomplete intake, and manual evidence hunting are. CertHub changes what arrives — and how you review it.
Document structuring
Sterilizator 20A · MDR Annex II
Drop the full technical file
GSPR and Essential Principles mappings are generated from the TechDoc, manufacturer-confirmed, instead of lengthy forms.
Completeness and consistency are checked before an expert opens the case. Gaps are flagged on entry.
Document structuring
Sterilizator 20A · MDR Annex II
Drop the full technical file
Named review steps: completeness, evidence mapping, findings and queries, report draft, human decision.
Not a generic LLM on PDFs. Not a reviewer chat. Experts judge. The system fetches. CertHub never takes a conformity decision.
Assessment review
Sterilizator 20A · MDR · Assessor workspace
48
AI mapped
31
Validated
6
Open queries
GSPR 1
Device description §4.2
GSPR 4
Risk management file · ISO 14971
GSPR 10.1
Clinical evaluation · CER ch.6
Today: complete, mapped document packages — not an unstructured ZIP dump — into the intake format you define.
Long term: machine-readable exchange aligned with the DIGICAP direction. Same channel routes matching manufacturer demand to you.
Digital transmission
Sterilizator 20A · Manufacturer → partner NB
From CertHub manufacturer
MDR Class IIb · Your intake format
Documents now
Mapped package · completeness-checked
Selected for this filing
Structured data
Machine-readable exchange · long-term
Route to partner Notified Body
Your review system stays · no rip-and-replace
How we engage
Three steps at your pace. Your decision on measured numbers.
01
Interface and referrals. We route matching manufacturers to you and align on your digital intake format. No cost, no procurement, no committee for the channel step.
02
Proof of Value on your real cases. Time saved and error reduction measured before any rollout decision. Your checklists, your report formats, your VPC if required.
03
Configuration and rollout at your pace, expert by expert. Optional Co-Pilot adoption with per-case pricing that scales with volume.
Why not the alternatives
Every alternative starts too late. CertHub starts at the manufacturer source.
Digitizes the notified body's process, but intake still begins with unstructured files. CertHub structures documentation in the manufacturer source system before it reaches you.
No MDR or IVDR substance. The limitation appears exactly where conformity assessment gets serious. CertHub ships MedTech-native checklists and GSPR logic.
Internal AI builds succeed far less often than specialized partnerships, and they tie senior reviewers to permanent engineering liability. Prove CertHub on your cases first.
Trust and control
EU-hosted in Germany (Frankfurt). Tenant isolation. No training on customer data. Your checklists, configurations, and assessment scheme remain your IP. CertHub never takes a conformity decision. ISO/IEC 27001 certification underway. Full posture in the Trust Center.
Cannot find the answer you need? Book a demo and we will route you to the right person.
Next step
Thirty minutes. We route you to The Bridge or Auditor Co-Pilot based on how you assess today.
