/**
 * MHRA UK Software as a Medical Device (SaMD) + UKCA marking Compliance Pack
 *
 * Regulation:
 *   - UK Medical Devices Regulations 2002 (as amended) — primary statute
 *   - MHRA Software and AI as a Medical Device Change Programme (active
 *     2021–present), including the AI Airlock pilot pathway (2024+).
 *   - MHRA SaMD guidance (IMDRF-aligned: SaMD risk class I, IIa, IIb, III)
 *   - UKCA marking (UK Conformity Assessed) — replacing CE marking for
 *     Great Britain post-Brexit (Northern Ireland still uses CE/UKCA-NI
 *     under the Windsor Framework)
 *
 * Jurisdiction: GB (Great Britain) primary; UKCA marking applies in
 *   England, Scotland, Wales. Northern Ireland operates a parallel
 *   CE/UKNI regime.
 * Authority: MHRA (Medicines and Healthcare products Regulatory Agency)
 *
 * Why this pack:
 *   - Required for any AI-based or software-based product placed on the
 *     UK market that meets the medical-device definition. Distinct from
 *     EU MDR / IVDR (separate pack: eu-mdr-ivdr).
 *   - SaMD AI products are increasingly the customer profile for UK
 *     Wave 1 NHS sales. MHRA reform is fast-moving (UKCA timelines,
 *     Future Regulations, AI Airlock); this pack tracks the operational
 *     evidence customers need.
 *   - Depends on Pack 7 (NHS Clinical Safety DCB0129/0160, shipped PR #400)
 *     for the clinical-safety-case spine — MHRA SaMD evidence inherits
 *     the DCB0129 hazard log + CSCR.
 *
 * Key obligations encoded in this pack:
 *   1. SaMD risk classification (I, IIa, IIb, III) recorded; classification
 *      rationale documented and reviewed at every product change.
 *   2. UKCA marking attestation — Declaration of Conformity, Technical
 *      Documentation file, applicable harmonised standards (ISO 13485,
 *      ISO 14971, IEC 62304, IEC 82304, ISO 14155 where clinical
 *      investigation applies).
 *   3. Clinical evaluation evidence (per UK MDR Schedule 2A) and
 *      clinical investigation records where required by class.
 *   4. Post-market surveillance plan (active for the device lifetime),
 *      Periodic Safety Update Report (PSUR) cadence by class:
 *      Class I — every 5 years; IIa — every 2 years; IIb / III — annually.
 *   5. Vigilance / incident reporting:
 *      - Serious incidents: report to MHRA within 15 days (10 days for
 *        immediate threat to life)
 *      - Field Safety Corrective Actions (FSCA) + Field Safety Notices
 *        (FSN) workflow
 *   6. UK Responsible Person (UKRP) designation for non-UK manufacturers.
 *   7. Device registration with MHRA before placing on UK market.
 *   8. AI-specific overlays (MHRA SaMD change programme + AI Airlock):
 *      - Algorithm change protocol (ACP) where applicable
 *      - Pre-determined Change Control Plan (PCCP) for "learning" models
 *      - Locked-vs-adaptive declaration
 *      - Real-world performance monitoring
 *
 * Out of scope:
 *   - EU MDR / IVDR (separate pack: eu-mdr-ivdr)
 *   - DCB0129 / DCB0160 NHS clinical-safety case (separate pack:
 *     nhs-clinical-safety, shipped PR #400) — MHRA evidence layers on top
 *   - NHS DSPT (separate pack: nhs-dspt)
 *   - FDA SaMD (separate pack: fda-samd)
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * MHRA SaMD / UKCA category classifiers.
 *
 * Pack scope is MHRA-specific evidence: device registration, risk class,
 * UKCA technical documentation, clinical evaluation, post-market
 * surveillance, vigilance / incident reporting, and AI-specific change-
 * control artefacts (ACP / PCCP). Personal-data classification is
 * delegated to nhs-dspt + uk-gdpr packs.
 */
export declare const MHRA_SAMD_UKCA_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const MHRA_SAMD_UKCA_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
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