--- title: "Life Sciences Regulatory Glossary | QbD Group" description: "Clear definitions of 40+ life sciences regulatory terms: EU MDR, IVDR, GMP, GCP, CSV, QPPV, CER, notified body and more, explained by QbD Group experts." url: https://qbdgroup.com/en/knowledge-center/glossary type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Life Sciences Regulatory Glossary | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary" --- Knowledge Center # Life Sciences Regulatory Glossary Plain-language definitions of the regulations, standards, and acronyms our experts use every day across pharma, biotech, medical devices, and IVD. 49 terms defined ## Most looked up CERCSVEU MDRGMPISO 13485IVDRNotified BodySaMD Search the glossary ## A ### [ANDA](https://qbdgroup.com/en/knowledge-center/glossary/anda) Regulatory Affairs Abbreviated New Drug Application The FDA pathway for generic medicines. Instead of repeating clinical efficacy trials, the applicant demonstrates that the generic is pharmaceutically equivalent and bioequivalent to an approved reference product, alongside a full quality and manufacturing dossier. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/anda) ## B ### [Batch Release](https://qbdgroup.com/en/knowledge-center/glossary/batch-release) CMC & Manufacturing The formal decision that a manufactured batch may be supplied. It follows review of the batch record, deviations, and test results, and in the EU requires certification by a Qualified Person against GMP and the marketing authorisation. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/batch-release) ## C ### [CAPA](https://qbdgroup.com/en/knowledge-center/glossary/capa) Quality & GMP Corrective And Preventive Action The quality process for investigating a problem, correcting it, addressing its root cause so it does not recur, and preventing similar issues elsewhere. Effectiveness checks close the loop, and CAPA records are a standard focus of inspections and audits. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/capa) ### [CE Marking](https://qbdgroup.com/en/knowledge-center/glossary/ce-marking) Regulatory Affairs The manufacturer's declaration that a product complies with the applicable EU legislation and may be placed on the European market. For medical devices and IVDs it follows a conformity assessment, usually involving a notified body outside the lowest risk classes. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/ce-marking) ### [CER](https://qbdgroup.com/en/knowledge-center/glossary/cer) Clinical Clinical Evaluation Report The MDR deliverable that documents the systematic appraisal of clinical data for a medical device. It weighs literature, clinical investigations, and post-market data against the intended purpose to confirm safety, performance, and an acceptable benefit-risk profile. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/cer) ### [Change Control](https://qbdgroup.com/en/knowledge-center/glossary/change-control) Quality & GMP The formal system for proposing, assessing, approving, implementing, and documenting changes to facilities, equipment, materials, processes, or documentation, including the regulatory impact assessment that determines whether a variation must be filed. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/change-control) ### [CQV](https://qbdgroup.com/en/knowledge-center/glossary/cqv) Quality & GMP Commissioning, Qualification and Validation The staged programme that brings facilities, utilities, equipment, and processes into GMP service: commissioning of the installation, qualification against design and operating requirements, and validation that the process reliably delivers the required quality. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/cqv) ### [CSV](https://qbdgroup.com/en/knowledge-center/glossary/csv) CMC & Manufacturing Computer System Validation Documented evidence that a computerised system used in a GxP process consistently does what it is specified to do. It covers requirements, risk assessment, supplier assessment, testing, data integrity, and controls under EU GMP Annex 11 and 21 CFR Part 11. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/csv) ### [CTA](https://qbdgroup.com/en/knowledge-center/glossary/cta) Clinical Clinical Trial Application The application seeking authorisation to run a clinical trial in a given territory. It bundles the protocol, investigator's brochure, IMP dossier, informed consent documents, and site and investigator information for regulatory and ethics review. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/cta) ### [CTIS](https://qbdgroup.com/en/knowledge-center/glossary/ctis) Clinical Clinical Trials Information System The single EU portal and database for clinical trial applications under CTR 536/2014. Sponsors submit one dossier for all concerned member states and manage the full lifecycle there: authorisation, substantial modifications, safety reporting, and results. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/ctis) ### [CTR 536/2014](https://qbdgroup.com/en/knowledge-center/glossary/ctr-536-2014) Clinical EU Clinical Trials Regulation The regulation harmonising clinical trial authorisation and supervision across the EU. It introduced a single submission through CTIS, coordinated assessment between member states, defined assessment timelines, and public transparency of trial information. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/ctr-536-2014) ### [Cybersecurity](https://qbdgroup.com/en/knowledge-center/glossary/cybersecurity) Devices & Software For regulated devices, the set of design and process controls protecting confidentiality, integrity, and availability, as described in MDCG 2019-16. It spans secure design, threat modelling, vulnerability handling, and security updates over the supported lifetime. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/cybersecurity) ## D ### [Deviation](https://qbdgroup.com/en/knowledge-center/glossary/deviation) Quality & GMP A departure from an approved procedure, specification, or standard during a GMP activity. Each deviation is documented, classified by impact, investigated for root cause, and assessed for product quality impact before batch disposition. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/deviation) ## E ### [EU AI Act](https://qbdgroup.com/en/knowledge-center/glossary/eu-ai-act) Devices & Software The European regulation on artificial intelligence, applying a risk-based framework. AI-enabled medical devices and IVDs generally fall in the high-risk category, adding requirements on data governance, transparency, human oversight, robustness, and post-market monitoring on top of MDR or IVDR. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/eu-ai-act) ### [EU MDR](https://qbdgroup.com/en/knowledge-center/glossary/eu-mdr) Regulatory Affairs Regulation (EU) 2017/745 on medical devices The European regulation governing the design, manufacture, and placing on the market of medical devices. It replaced the Medical Device Directive and tightened clinical evidence, technical documentation, traceability, and post-market surveillance requirements for all device classes. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/eu-mdr)[Related: MedTech Gateway to Europe](https://qbdgroup.com/en/industries/medical-devices/gateway-to-europe) ### [EUDAMED](https://qbdgroup.com/en/knowledge-center/glossary/eudamed) Regulatory Affairs European Database on Medical Devices The European Commission database supporting MDR and IVDR. Its modules cover actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/eudamed) ### [Extractables & Leachables](https://qbdgroup.com/en/knowledge-center/glossary/extractables-and-leachables) CMC & Manufacturing Extractables are compounds that can be drawn out of a container, device, or manufacturing material under exaggerated conditions; leachables are those that actually migrate into the product in normal use. Both are studied to support patient safety assessments. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/extractables-and-leachables) ## G ### [GCP](https://qbdgroup.com/en/knowledge-center/glossary/gcp) Clinical Good Clinical Practice The international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects, set out in ICH E6. Compliance protects participant rights and safety and makes trial data credible to regulators. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/gcp)[Related: Clinical Solutions](https://qbdgroup.com/en/services/clinical-solutions) ### [GDP](https://qbdgroup.com/en/knowledge-center/glossary/gdp) Quality & GMP Good Distribution Practice The quality standard for the storage, transport, and distribution of medicinal products. It covers wholesale licensing, qualified personnel, temperature control and mapping, supplier and customer qualification, and the handling of returns and falsified medicines. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/gdp) ### [GLP](https://qbdgroup.com/en/knowledge-center/glossary/glp) Quality & GMP Good Laboratory Practice The quality system governing how non-clinical safety studies are planned, performed, recorded, reported, and archived, so that regulators can rely on the data submitted in a marketing application. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/glp) ### [GMP](https://qbdgroup.com/en/knowledge-center/glossary/gmp) Quality & GMP Good Manufacturing Practice The set of rules ensuring medicinal products are consistently produced and controlled to the quality standards required by their intended use and marketing authorisation. In Europe it is set out in EudraLex Volume 4; in the US in 21 CFR Parts 210 and 211. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/gmp)[Related: Quality Assurance services](https://qbdgroup.com/en/services/quality-assurance) ### [GVP](https://qbdgroup.com/en/knowledge-center/glossary/gvp) Pharmacovigilance Good Pharmacovigilance Practices The EMA modules setting out how marketing authorisation holders and authorities must run pharmacovigilance: quality systems, the pharmacovigilance system master file, risk management, signal management, safety reporting, and post-authorisation safety studies. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/gvp)[Related: Pharmacovigilance services](https://qbdgroup.com/en/services/pharmacovigilance) ## I ### [ICH Q3C](https://qbdgroup.com/en/knowledge-center/glossary/ich-q3c) CMC & Manufacturing The ICH guideline on residual solvents in pharmaceuticals. It classifies solvents by toxicity, sets permitted daily exposures and concentration limits, and underpins the analytical control strategy, typically by gas chromatography. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/ich-q3c) ### [IEC 62304](https://qbdgroup.com/en/knowledge-center/glossary/iec-62304) Devices & Software The standard defining the software development lifecycle for medical device software: safety classification A to C, planning, requirements, architecture, verification, configuration management, problem resolution, and maintenance after release. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/iec-62304) ### [Informed Consent](https://qbdgroup.com/en/knowledge-center/glossary/informed-consent) Clinical The documented process by which a participant voluntarily confirms willingness to take part in a trial, after being informed of its purpose, procedures, risks, benefits, and their right to withdraw at any time without penalty. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/informed-consent) ### [Inspection Readiness](https://qbdgroup.com/en/knowledge-center/glossary/inspection-readiness) Quality & GMP The state of being able to host a regulatory inspection at short notice: current documentation, traceable records, trained staff, closed CAPAs, and a rehearsed front-room and back-room process for handling requests during the inspection. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/inspection-readiness) ### [Investigator's Brochure](https://qbdgroup.com/en/knowledge-center/glossary/investigators-brochure) Clinical The compilation of clinical and non-clinical data on an investigational product that is relevant to its study in humans. It gives investigators the dosing, safety, and monitoring information they need and is updated as new data emerge. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/investigators-brochure) ### [ISO 13485](https://qbdgroup.com/en/knowledge-center/glossary/iso-13485) Quality & GMP The international standard for quality management systems specific to medical devices. Certification is the practical route to demonstrating the QMS requirements of MDR Article 10 and IVDR Article 10, and is expected by most notified bodies and customers. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/iso-13485) ### [ISO 14971](https://qbdgroup.com/en/knowledge-center/glossary/iso-14971) Devices & Software The standard for applying risk management to medical devices across the lifecycle: risk analysis, evaluation, control, evaluation of overall residual risk, and production and post-production information feeding back into the risk file. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/iso-14971) ### [IVDR](https://qbdgroup.com/en/knowledge-center/glossary/ivdr) Regulatory Affairs Regulation (EU) 2017/746 on in vitro diagnostic medical devices The European regulation for in vitro diagnostic medical devices. It introduced a risk-based classification (A to D), moved most IVDs under notified body oversight, and requires performance evaluation covering scientific validity, analytical performance, and clinical performance. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/ivdr)[Related: Medical Devices & IVD](https://qbdgroup.com/en/industries/medical-devices) ## L ### [Lifecycle Management](https://qbdgroup.com/en/knowledge-center/glossary/lifecycle-management) Regulatory Affairs The ongoing regulatory maintenance of an authorised product: variations, renewals, labelling updates, new indications, site or supplier changes, and responses to authority requests, all managed so the authorisation stays valid and current. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/lifecycle-management) ## M ### [MAA](https://qbdgroup.com/en/knowledge-center/glossary/maa) Regulatory Affairs Marketing Authorisation Application The dossier submitted to EMA or a national authority requesting permission to market a medicinal product in Europe. It compiles quality, non-clinical, and clinical data in the Common Technical Document format, together with labelling and risk management documentation. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/maa) ### [MIA](https://qbdgroup.com/en/knowledge-center/glossary/mia) Quality & GMP Manufacturing and Importation Authorisation The licence a national competent authority grants for manufacturing, importing, or batch-releasing medicinal products in the EU. It names the authorised sites, activities, dosage forms, and the Qualified Persons attached to the licence. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/mia) ## N ### [NDA](https://qbdgroup.com/en/knowledge-center/glossary/nda) Regulatory Affairs New Drug Application The application through which a sponsor asks the FDA to approve a new medicinal product for the United States market. It presents the full development package: chemistry and manufacturing, non-clinical safety, clinical efficacy and safety, and proposed labelling. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/nda) ### [Notified Body](https://qbdgroup.com/en/knowledge-center/glossary/notified-body) Regulatory Affairs An independent organisation designated by an EU member state to assess whether medical devices and IVDs meet regulatory requirements before CE marking. Its conformity assessment covers the quality management system, technical documentation, and ongoing surveillance audits. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/notified-body) ## P ### [PMCF](https://qbdgroup.com/en/knowledge-center/glossary/pmcf) Clinical Post-Market Clinical Follow-up The proactive collection and evaluation of clinical data from a CE-marked device in normal use, planned to confirm safety and performance, keep the benefit-risk determination current, and detect emerging risks or off-label use. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/pmcf) ### [PMS](https://qbdgroup.com/en/knowledge-center/glossary/pms) Pharmacovigilance Post-Market Surveillance The systematic collection and review of experience gained from devices or medicines already on the market, feeding complaint handling, vigilance reporting, risk management, and the periodic safety update report or PSUR equivalent for devices. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/pms) ### [PSUR](https://qbdgroup.com/en/knowledge-center/glossary/psur) Pharmacovigilance Periodic Safety Update Report The periodic report in which a marketing authorisation holder re-evaluates the benefit-risk balance of an authorised medicine using cumulative safety data, exposure estimates, and signal evaluations over the reporting interval. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/psur) ## Q ### [QMS](https://qbdgroup.com/en/knowledge-center/glossary/qms) Quality & GMP Quality Management System The documented set of processes, responsibilities, and records through which an organisation plans, controls, and improves product quality and regulatory compliance, from design and supplier control through production, release, complaints, and CAPA. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/qms) ### [QPPV](https://qbdgroup.com/en/knowledge-center/glossary/qppv) Pharmacovigilance Qualified Person for Pharmacovigilance The individual a marketing authorisation holder must appoint in the EU to establish and maintain the pharmacovigilance system. The QPPV has oversight of the safety profile of all authorised products and is the authorities' round-the-clock point of contact. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/qppv) ### [Qualified Person](https://qbdgroup.com/en/knowledge-center/glossary/qualified-person) Quality & GMP The named individual legally responsible under EU law for certifying that each batch of a medicinal product was manufactured and tested in line with GMP and the marketing authorisation before it is released to the market. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/qualified-person) ## R ### [Risk Management Plan](https://qbdgroup.com/en/knowledge-center/glossary/risk-management-plan) Pharmacovigilance The document describing what is known and unknown about a medicine's safety, the measures planned to characterise and minimise its risks, and how the effectiveness of those measures will be measured over the product's lifecycle. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/risk-management-plan) ## S ### [SaMD](https://qbdgroup.com/en/knowledge-center/glossary/samd) Devices & Software Software as a Medical Device Software intended for a medical purpose that performs that purpose on its own, without being part of a hardware device. Under MDR and IVDR it is qualified and classified in its own right, with clinical evidence, usability, and cybersecurity requirements. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/samd)[Related: Medical Device Software](https://qbdgroup.com/en/industries/medical-devices/mdsw) ### [Scientific Advice](https://qbdgroup.com/en/knowledge-center/glossary/scientific-advice) Regulatory Affairs A formal consultation in which a developer asks a regulator, such as EMA or a national agency, for guidance on its development plan. Advice typically covers quality, non-clinical, and clinical strategy and reduces the risk of objections later in the procedure. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/scientific-advice) ### [Signal Detection](https://qbdgroup.com/en/knowledge-center/glossary/signal-detection) Pharmacovigilance The activity of identifying new or changed safety information from spontaneous reports, literature, studies, and other sources, then validating and prioritising it to decide whether the product's risk profile or labelling needs to change. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/signal-detection) ### [Stability Study](https://qbdgroup.com/en/knowledge-center/glossary/stability-study) CMC & Manufacturing A study following ICH conditions that measures how a product's quality attributes change over time under defined temperature and humidity, establishing the retest period or shelf life and the recommended storage conditions. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/stability-study) ### [SUSAR](https://qbdgroup.com/en/knowledge-center/glossary/susar) Pharmacovigilance Suspected Unexpected Serious Adverse Reaction A serious adverse reaction in a clinical trial that is suspected to relate to the investigational product and whose nature or severity is not consistent with the reference safety information. SUSARs are subject to expedited reporting to authorities and ethics committees. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/susar) ## T ### [Technical Documentation](https://qbdgroup.com/en/knowledge-center/glossary/technical-documentation) Regulatory Affairs The structured evidence file a device or IVD manufacturer maintains to demonstrate conformity, as set out in MDR/IVDR Annexes II and III. It covers device description, design and manufacturing information, risk management, verification and validation, clinical evidence, and post-market data. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/technical-documentation) ## U ### [UDI](https://qbdgroup.com/en/knowledge-center/glossary/udi) Regulatory Affairs Unique Device Identification A globally unique code carried on device labels and packaging so that a product can be identified and traced through distribution and use. It combines a device identifier for the model with a production identifier for batch, serial number, or expiry. [Read the full definition](https://qbdgroup.com/en/knowledge-center/glossary/udi) ## Need more than a definition? Our regulatory, quality, and clinical specialists turn these requirements into working submissions, systems, and studies. [Explore our services](https://qbdgroup.com/en/services)[Talk to an expert](https://qbdgroup.com/en/contact) [Back to the Knowledge Center](https://qbdgroup.com/en/knowledge-center) --- Source: https://qbdgroup.com/en/knowledge-center/glossary — © QbD Group. Quote freely with attribution and a link back.