/**
 * EU MDR + IVDR Compliance Pack
 *
 * EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic
 * Regulation (IVDR) 2017/746 -- the joint EU medical device regulatory
 * framework governing placing medical devices and IVDs on the EU market.
 *
 * Regulatory authority:
 *   - MDR Regulation (EU) 2017/745: applicable from 26 May 2021
 *     (Class I May 2021; Class IIa/IIb/III per transition timeline).
 *     Replaces Medical Device Directive (MDD) 93/42/EEC and Active
 *     Implantable Medical Device Directive (AIMDD) 90/385/EEC.
 *   - IVDR Regulation (EU) 2017/746: applicable from 26 May 2022
 *     for Class D; Class C (May 2025); Class B (May 2026); Class A
 *     sterile (May 2026). Replaces IVD Directive 98/79/EC.
 *   - Both regulations share the same Notified Body / EUDAMED /
 *     UDI infrastructure and conformity assessment framework.
 *   - National competent authorities: BfArM (Germany), ANSM (France),
 *     MHRA (UK -- now separate post-Brexit), etc.
 *   - MDCG (Medical Device Coordination Group): joint guidance body
 *     for MDR/IVDR implementation.
 *
 * Key distinctions from FDA SaMD (fda-samd.ts):
 *   - EU: classification by MDR/IVDR classes (I, IIa, IIb, III / A, B, C, D)
 *     vs FDA: IMDRF SaMD categories (Category I-IV)
 *   - EU: Notified Body conformity assessment + CE marking
 *     vs FDA: 510(k) / De Novo / PMA clearance or approval
 *   - EU: EUDAMED registration database
 *     vs FDA: FDA GUDID / 510(k) database
 *   - EU: MDR/IVDR clinical evaluation + PMCF (Post-Market Clinical Follow-Up)
 *     vs FDA: PCCP (Predetermined Change Control Plan) + real-world evidence
 *   - UK post-Brexit: MHRA UKCA marking (not CE marking) required for
 *     Great Britain market; Northern Ireland follows EU rules (CE marking).
 *
 * AI/Software as Medical Device (SaMD) under MDR/IVDR:
 *   - MDCG 2019-16 (rev.1): guidance on qualification and classification
 *     of software under MDR/IVDR. Software driving or influencing clinical
 *     decisions may qualify as a medical device.
 *   - MDCG 2022-2: guidance on medical device standalone software and AI.
 *   - Learning algorithms: AI/ML models that continuously learn may
 *     require re-qualification if the change is significant.
 *   - Cybersecurity: MDCG 2019-16 and ENISA guidance on medical device
 *     cybersecurity apply to AI SaMD under MDR/IVDR.
 *
 * Current state (2026):
 *   - MDR fully applicable; EUDAMED fully operational.
 *   - IVDR Class C transition deadline May 2025 passed; Class B and
 *     A sterile transition May 2026 approaching.
 *   - Notified Body capacity constraint remains a practical concern
 *     for conformity assessment timelines.
 *   - MDCG 2024 AI guidance updates expected on adaptive algorithms.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * EU MDR + IVDR category classifiers.
 * Covers medical device classification data, IVD classification data,
 * clinical evaluation records, post-market surveillance data,
 * and vigilance reporting.
 */
export declare const EU_MDR_IVDR_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const EU_MDR_IVDR_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
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