What VitaRegX covers — in regulatory detail
We track every framework we operate against to the article, annex, and amendment level. Below is exactly what is in scope today and what is on the roadmap.
EU MDR coverage
| Framework | What VitaRegX handles | Status |
|---|---|---|
| EU MDR 2017/745 | Classification (Annex VIII), GSPRs (Annex I), Technical documentation (Annex II/III), Clinical evaluation, PMS Articles 83–86, Vigilance Articles 87–92 | Live |
| MDCG guidance set | Classification (MDCG 2021-24), Clinical evaluation (MDCG 2020-13), PMS (MDCG 2020-7) | Live |
| EUDAMED | Device registration, certificates, vigilance modules — mandatory from 28 May 2026 | — |
| IVDR 2017/746 | Classification, performance evaluation | In scope, phased rollout |
UK MDR coverage
| Framework | What VitaRegX handles | Status |
|---|---|---|
| UK MDR 2002 (incl. SI 2024/1368) | Classification (Reg. 7), Essential Requirements (Schedule 2A), Registration (DORS) | Live |
| PSUR cadence | Annual for Class IIb under SI 2024/1368 reg. 44ZM(6); 3-working-day Approved Body access SLA | Live |
| GB CE acceptance | Through 30 June 2028 (MDD/AIMDD), 30 June 2030 (EU MDR/IVDR) | Tracked |
| MHRA guidance | Software, IVDs, transitional pathways | Live |
| MHRA SME fee waiver | Extended into 2026–27 (excluding active implantables) | Tracked |
Biocidal Products coverage
Some products that look like medical devices are regulated as biocidal products. Misclassification at this boundary costs months. VitaRegX models the BPR regime as a first-class track, not an MDR exception.
Biocidal Products coverage
| Framework | What VitaRegX handles | Status |
|---|---|---|
| EU BPR 528/2012 | Active substance approval, product authorisation, treated articles, Article 95 supplier listing | Live |
| GB BPR | Post-Brexit UK biocides regime administered by HSE; parallel to EU BPR but separate dossiers | Live |
| ECHA Article 95 list | Suppliers of active substances; required check before placing biocidal products on the EU market | Live |
| Treated articles | Articles 58 and 94 of BPR 528/2012; labelling requirements where antimicrobial claims are made | Live |
| HSE guidance | UK biocides post-Brexit, hand sanitisers, disinfectants, treated articles | Live |
MD / BPR boundary — worked example
A urinary catheter coated with silver nanoparticles is a medical device under MDR. A surface disinfectant containing the same silver active substance is a biocidal product under BPR. The intended purpose, not the active substance, drives the regime. VitaRegX surfaces this determination explicitly with a citation to BPR 528/2012 Article 3 (definitions) and MDCG 2022-5 (borderline manual).
Northern Ireland operates as a third regime — for both medical devices and biocides
Under the Windsor Framework, NI follows EU MDR for medical devices and EU BPR for biocidal products, with UK-specific overlays. NI requires NI_AR or EU_AR (not UKRP) for medical devices. CE marking is accepted via an EU Notified Body, with UKNI required for UK Approved Body conformity. For biocides, EU BPR active-substance approvals and product authorisations apply in NI; GB BPR (HSE) does not. VitaRegX models NI as a first-class third regime across both pathways — distinct from EU and GB — in classification, registrations, and export checks.
Standards in scope
- ISO 13485 — Quality management
- ISO 14971 — Risk management
- IEC 62304 — Software lifecycle
- IEC 62366-1 — Usability engineering
- ISO 10993 — Biocompatibility
- ISO 15223-1+A1:2025 — Symbols (incl. updated EU REP symbol)
Special device characteristics (within the MDR track)
Some device characteristics trigger specific obligations within the medical device regime. VitaRegX surfaces these automatically. The MD / BPR boundary is handled separately, in the Biocidal Products section above.
- Article 52(10) — Devices incorporating substances of human origin
- Rule 19 — Nanomaterials
- Annex I para 10.4 — CMR / ED substances above 0.1% by weight
- Animal tissue — 4-week consultation with TSE CEP; 12 weeks without
Roadmap
- FDA 510(k) and PMA pathways Roadmap
- Health Canada MDEL/MDL Roadmap
- TGA Australia Roadmap
- International Recognition Procedure once policy finalises Roadmap
Coverage refers to the regulatory frameworks VitaRegX indexes and operates against. It does not constitute legal advice or any guarantee of regulatory outcome. VitaRegX is NOT itself a medical device, NOT Software as a Medical Device (SaMD), and NOT a substitute for a Notified Body, UK Approved Body, or HSE conformity assessment. Final regulatory decisions remain with the manufacturer and their qualified RA/QA staff.