Directive (EU) 2017/1572
1 entryPrinciples and guidelines of good manufacturing practice for medicinal products
Norms and regulations
Every standard and law our glossaries cite.
Glossary entries name the standard or legal act that defines them. This index collects those references in one place — from ISO 12100 and IEC 61508 to the AI Act and 21 CFR Part 11 — so you can start from a norm and find every term that depends on it.
The index is compiled automatically from the reference field of each glossary entry and grows with the glossaries. It shows where a document is cited, not whether it applies to your product: naming a standard or law never implies compliance, and status and dates are stated in the entries themselves.
- Regulations and legal acts
- 52
- Norms, standards and guidelines
- 213
- Citing glossary entries
- 736
Regulations and legal acts
European Union29
Regulations, directives, decisions and the EU guidance they rely on
Directive (EU) 2022/2555
1 entryNIS 2 Directive (NIS2)
Glossary entry: NIS 2 DirectiveDirective 1999/92/EC
2 entriesATEX workplace directive (ATEX 137)
Directive 2001/83/EC
1 entryCommunity code relating to medicinal products for human use
Directive 2004/10/EC
1 entryGood Laboratory Practice Directive (GLP Directive)
Directive 2011/65/EU
1 entryRestriction of Hazardous Substances Directive (RoHS)
Glossary entry: RoHSDirective 2014/30/EU
1 entryElectromagnetic Compatibility Directive (EMC Directive)
Directive 2014/35/EU
1 entryLow Voltage Directive (LVD)
Glossary entry: Low Voltage DirectiveEMA GVP modules
1 entryGood pharmacovigilance practices (GVP)
Glossary entry: Good pharmacovigilance practices (GVP)EU GMP Annex 1
1 entryManufacture of sterile medicinal products
Glossary entry: EU GMP Annex 1 (sterile medicinal products)EU GMP Annex 11
2 entriesComputerised systems
Glossary entry: EU GMP Annex 11 (computerized systems)EU GMP Annex 15
3 entriesQualification and validation
Glossary entry: EU GMP Annex 15 (qualification and validation)EU GMP Annex 16
1 entryCertification by a Qualified Person and batch release
EU GMP Annex 22
1 entryArtificial intelligence (draft)
Cited as EudraLex Volume 4, draft Annex 22 (July 2025)
Glossary entry: EU GMP Annex 22 (artificial intelligence, draft)EudraLex Volume 4
5 entriesEU guidelines for good manufacturing practice (EU GMP)
Cited as EudraLex Volume 4 Part II · EudraLex Volume 4, Part I, Chapter 1 · EudraLex Volume 4, Part I, Chapter 4
Guidelines 2013/C 343/01
1 entryGuidelines on good distribution practice of medicinal products for human use (GDP)
Pharmacovigilance Implementing Regulation
MDCG 2019-11
1 entryRegulation (EU) 2017/745
28 entriesMedical Device Regulation (MDR)
Glossary entry: Medical Device Regulation (MDR)- AI in medical devices (MDR, IVDR and AI Act)
- Clinical evaluation (MDR)
- Clinical investigation (MDR)
- Conformity assessment (MDR)
- Device classification (MDR)
- Drug-device combination (MDR Article 117)
Show all 28 entries
- Economic operators (MDR and IVDR)
- EUDAMED
- General safety and performance requirements (GSPR)
- In-house devices (MDR and IVDR Article 5(5))
- Labeling and instructions for use (MDR and IVDR)
- MDCG guidance
- Medical device (MDR)
- Medical Device Regulation (MDR)
- Medical device software (MDSW)
- Medical device vs. IVD: MDR vs. IVDR
- Notified body (MDR and IVDR)
- Periodic safety update report (PSUR)
- Person responsible for regulatory compliance (PRRC)
- Post-market clinical follow-up (PMCF)
- Post-market surveillance (MDR and IVDR)
- Rule 11: software classification (MDR)
- Summary of safety and clinical performance (SSCP)
- Targeted revision of the MDR and IVDR (proposal)
- Technical documentation (MDR and IVDR)
- Transition periods (MDR and IVDR)
- Unique Device Identification (UDI)
- Vigilance (MDR and IVDR)
Regulation (EU) 2017/746
22 entriesIn Vitro Diagnostic Medical Devices Regulation (IVDR)
Glossary entry: In Vitro Diagnostic Medical Devices Regulation (IVDR)- AI in medical devices (MDR, IVDR and AI Act)
- Companion diagnostic (IVDR)
- Device classification (IVDR)
- Economic operators (MDR and IVDR)
- General safety and performance requirements (GSPR)
- In vitro diagnostic medical device (IVD)
Show all 22 entries
- In Vitro Diagnostic Medical Devices Regulation (IVDR)
- In-house devices (MDR and IVDR Article 5(5))
- Labeling and instructions for use (MDR and IVDR)
- Medical device vs. IVD: MDR vs. IVDR
- Notified body (MDR and IVDR)
- Performance evaluation (IVDR)
- Performance study (IVDR)
- Periodic safety update report (PSUR)
- Person responsible for regulatory compliance (PRRC)
- Post-market performance follow-up (PMPF)
- Post-market surveillance (MDR and IVDR)
- Targeted revision of the MDR and IVDR (proposal)
- Technical documentation (MDR and IVDR)
- Transition periods (MDR and IVDR)
- Unique Device Identification (UDI)
- Vigilance (MDR and IVDR)
Regulation (EU) 2023/1230
10 entriesMachinery Regulation
Glossary entry: Machinery Regulation (EU) 2023/1230Regulation (EU) 2023/1542
1 entryBatteries Regulation
Regulation (EU) 2024/1689
21 entriesArtificial Intelligence Act (AI Act)
Glossary entry: EU AI Act- AI in medical devices (MDR, IVDR and AI Act)
- AI literacy (AI Act)
- AI risk planning
- AI system (AI Act)
- Annex I Section A and Section B (AI Act)
- Conformity assessment (AI Act)
Show all 21 entries
- Deployer (AI Act)
- EU AI Act
- Fundamental rights impact assessment (AI Act)
- General-purpose AI model (AI Act)
- GPAI Code of Practice
- High-risk AI system (AI Act)
- Human oversight (AI Act)
- Instructions for use (AI Act)
- Machinery AI timeline: 2027 vs. 2028
- Prohibited AI practices (AI Act)
- Provider (AI Act)
- Risk-based approach (AI Act)
- Safety component (AI Act)
- Technical documentation (AI Act)
- Transparency obligations (AI Act)
Regulation (EU) 2024/1781
7 entriesEcodesign for Sustainable Products Regulation (ESPR)
Glossary entry: Ecodesign for Sustainable Products Regulation (ESPR)Regulation (EU) 2024/2847
1 entryCyber Resilience Act (CRA)
Glossary entry: Cyber Resilience Act (CRA)Regulation (EU) 2026/1744
3 entriesRegulation (EU) No 536/2014
1 entryClinical Trials Regulation
Regulation (EU) No 1025/2012
1 entryRegulation on European standardisation
United States17
Federal statutes, the Code of Federal Regulations, executive orders, state laws and FDA guidance
21 CFR Part 11
2 entriesElectronic records; electronic signatures
Glossary entry: 21 CFR Part 11 (electronic records and signatures)21 CFR Part 58
2 entriesGood laboratory practice for nonclinical laboratory studies
21 CFR Part 210
2 entriesCurrent good manufacturing practice in manufacturing, processing, packing or holding of drugs
21 CFR Part 211
2 entriesCurrent good manufacturing practice for finished pharmaceuticals
21 CFR Part 807
1 entryEstablishment registration and device listing, premarket notification
21 CFR Part 814
1 entryPremarket approval of medical devices
21 CFR Part 820
1 entryQuality Management System Regulation (QMSR)
Glossary entry: Quality Management System Regulation (QMSR, 21 CFR Part 820)21 CFR Part 830
1 entryUnique device identification
Glossary entry: Unique Device Identification (UDI)29 CFR Part 1910
5 entriesOccupational safety and health standards (OSHA)
Cited as 29 CFR 1910.147 · 29 CFR 1910.212
California SB 53
1 entryTransparency in Frontier Artificial Intelligence Act
Glossary entry: California SB 53 (Transparency in Frontier AI Act)Colorado SB 24-205
1 entryColorado AI Act
Glossary entry: Colorado AI Act