Evidence scatter
Test reports, risk files, and legacy documents drift apart after every design change. Reviewers ask 'where's the source?' — and the answer is in three places.
Regulatory intelligence for MedTech
Build MDR and UK MDR submission documentation that withstands regulatory review
VitaRegX is decision-support software for Regulatory Affairs and Quality teams at Class IIa and IIb medical device manufacturers. It provides structured drafting, GSPR-to-evidence mapping, and citation traceability across EU MDR 2017/745 and UK MDR 2002 (SI 2024/1368).
Why MedTech teams come to VitaRegX
Regulatory work isn’t blocked by missing data. It’s blocked by missing traceability.
EU / UK divergence
Post-Brexit, the same device often classifies differently under EU MDR 2017/745 and UK MDR 2002. Rule 11 and Rule 14 upgrade risks are easy to overlook.
Review-cycle cost
Notified Body and reviewer questions cost weeks because the citation trail has to be rebuilt by hand each time.
What the platform does
Four modules, one regulatory file.
Gap Scout
Dual-track classification for EU MDR 2017/745 and UK MDR 2002. Maps applicable GSPRs and Essential Requirements. Flags evidence gaps before submission.
Learn moreDossier Architect
Drafts technical documentation aligned to EU MDR Annex II / III. Every assertion links to its source — test report, risk file, clinical reference, or regulation.
Learn moreClinical Synthesizer
Structures clinical evaluation: state-of-the-art review, equivalent device search, evidence indexing, and CER section drafts. Human review required before sign-off.
Learn moreWatchtower
Monitors MHRA CAS, FDA MAUDE, EUDAMED vigilance, and Field Safety Notices. Flags signal candidates and prompts PMS / PSUR updates.
Learn moreHow it works
From intake to post-market surveillance, in one traceable file.
- 01
Intake
Device or product description, intended purpose, target markets, active substances.
- 02
Boundary
Determine the regime: medical device under EU MDR 2017/745 vs biocidal product under EU BPR 528/2012.
- 03
Classify
Apply EU MDR and UK MDR 2002 rules, or BPR active-substance and product-type analysis.
- 04
Map
Applicable GSPRs and Essential Requirements identified; evidence gaps surfaced before they become reviewer findings.
- 05
Draft
Technical documentation generated with citation traceability back to source — every assertion linked.
- 06
Review & Monitor
Human approval, followed by continuous PMS or post-authorisation monitoring throughout the product lifecycle.
Every output is reviewable
If a reviewer asks “why”, the answer is one click away.
Medical device · MDR trackEU MDR 2017/745 · Annex I, Section 14.1
Generated GSPR justifications, with the cited regulation surfaced alongside them.
Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible the risks associated with the use of materials, substances and gases.
View sourceBiocidal product · BPR trackEU BPR 528/2012 · Article 95
Active-substance check resolves directly to the ECHA Article 95 entry.
The Agency shall make publicly available a list including the names of suppliers of active substances, distinguishing between substance suppliers and product suppliers.
View sourceEvery assertion VitaRegX generates is linked to the specific regulation, standard, or evidence file it came from — whether that's an EU MDR annex or an ECHA Article 95 listing. Audit-ready by construction.
What VitaRegX covers today
Medical devices and biocides. EU, UK, and Northern Ireland.
European Union
- EU MDR 2017/745Medical devices · Annex I (GSPR), Annex II / III (tech docs), Annex VIII (classification)
- EU BPR 528/2012Biocidal products and treated articles
- MDCG guidance setClassification (MDCG 2021-24) · Clinical (MDCG 2020-13) · PMS (MDCG 2020-7)
- ECHA Article 95 listActive substance supplier register
- EUDAMEDMandatory from 28 May 2026 — registration, certificates, vigilance
- IVDR 2017/746Classification, performance evaluation — phased rollout
United Kingdom
- UK MDR 2002Including SI 2024/1368 amendments · reg. 7 (classification) · Schedule 2A
- GB BPRAdministered by HSE post-Brexit
- MHRA guidanceSoftware, IVDs, transitional pathways
- Northern IrelandEU MDR + EU BPR via Windsor Framework · NI_AR / EU_AR routes · CE + UKNI
- GB CE acceptanceMDD / AIMDD through 30 June 2028 · EU MDR / IVDR through 30 June 2030
FDA and other regimes on the roadmap.
Built for regulated workflows
AI you can defend in a Notified Body audit.
Cited sources
Every regulatory assertion links to the article, annex, or guidance section it draws from.
Human-in-the-loop
High-stakes outputs require sign-off by a qualified RA / QA reviewer before they leave the platform.
Audit trail
Every draft, edit, citation, and approval is recorded and exportable as a regulatory record.
No training on customer data
Your regulatory files are never used to train shared models.
See VitaRegX on your device.
Send us your intended purpose and target markets. We'll show you a sample classification and traceability output in 30 minutes.