Conformo.ai has launched an AI platform for Notified Bodies that checks medical device technical documentation against MDR, IVDR and ISO 13485 requirements at intake, helping reviewers identify deficiencies earlier and reduce repeated assessment rounds.

Platform cut time per technical assessment by 21.2% in deployments, ahead of binding EU review deadlines that take effect in February 2027

FRANKFURT, DE / ACCESS Newswire / October 21, 2026 / Conformo.ai today launched its AI platform for Notified Bodies, the independent organizations that certify medical devices for the European market. The platform checks a manufacturer’s technical documentation against MDR, IVDR and ISO 13485 requirements at intake, so reviewers can raise every deficiency in a single round instead of discovering gaps months into an assessment.

Most of a certification is waiting

Medical device certification in Europe remains slow. In the European Commission’s latest Notified Bodies Survey, 71% of Notified Bodies reported that an MDR product certificate takes more than 13 months. An estimated 15,000-plus applications sit in the pipeline across 51 active Notified Bodies.

Review effort is not the main cause. A technical documentation assessment may represent six to ten weeks of reviewer time. Most of the remaining months go to round-trips: a gap found mid-review, a question sent to the manufacturer, weeks waiting for a response, and the file re-entering the queue.

That pattern is about to become costly. From February 25, 2027, Commission Implementing Regulation (EU) 2026/977 sets binding maximum timelines for MDR and IVDR assessments and caps how many times a Notified Body can pause the clock for manufacturer questions. From 2028, every Notified Body must publish its median time from application to certification.

Most of an MDR certification isn’t review. It’s waiting. Every gap found in month four instead of day one adds another round-trip. Conformo checks the whole file up front, allowing reviewers to raise questions earlier and spend more of their time on expert judgment. When certification moves faster without lowering the bar, safe devices can reach patients sooner.

How Conformo shortens assessments

  • Complete files at intake. Documentation is screened against the full Annex II and III structure before assessment begins, flagging missing sections, outdated standards and unaddressed requirements on day one.
  • One consolidated set of findings. Potential non-conformities are identified across the entire file and traced to the exact requirement and evidence, so deficiencies go to the manufacturer in a single round rather than a series.
  • Assessment records that survive handovers. Requirements, evidence and open questions live in the assessment record, not in a reviewer’s notes, so work resumes without rework after a clock-stop or a change of reviewer.
  • Draft reports. Structured assessment reports are drafted directly from the findings.

Measured results

In deployments to date, Conformo has delivered:

  • 21.2% less time per technical assessment
  • 5.8% higher assessment throughput per review team
  • 7.3% higher internal auditor utilization, reducing reliance on subcontractors

Every finding Conformo suggests is reviewed by a qualified assessor, and all certification decisions remain with the Notified Body. Customer data is encrypted at rest and in transit.

Manufacturers preparing a submission can check their documentation with Conformo’s free MDR Document Evidence Checker. For a detailed look at what drives certification timelines, read Why MDR Assessments Still Take 13-18 Months.

About Conformo.ai

Conformo.ai builds AI-assisted review infrastructure for Notified Bodies, Certification Bodies and testing, inspection and certification (TIC) organizations, starting with medical devices. Every finding is traceable to its source in the technical file, and every conformity decision remains with a qualified reviewer. Learn more at conformo.ai.

Media Contact

Company – Conformo.ai
Contact Person – Conformo.ai Media Relations
Email – contact@conformo.ai
Address – Frankfurt, Germany
Website – https://conformo.ai

SOURCE: Conformo.ai

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