MedTech and pharma regulation glossary: MDR, IVDR, ISO standards, GxP and ICH

Medical Device Regulation (MDR)

The EU Medical Device Regulation, Regulation (EU) 2017/745, is the EU law that sets the requirements for placing medical devices and certain products without a medical purpose on the EU market. It has applied since May 26, 2021 and replaced the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC.

EU · MDR

Medical device (MDR)

Under the EU Medical Device Regulation (EU) 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for a specific medical purpose, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. It does not achieve its principal intended action by pharmacological, immunological or metabolic means, although such means may assist its function.

EU · MDR

Medical device vs. IVD: MDR vs. IVDR

In EU law, medical devices fall under the Medical Device Regulation (EU) 2017/745 and in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. An IVD is a device intended for the in vitro examination of specimens derived from the human body; all other medical devices are governed by the MDR.

EU · MDR · IVDR

Economic operators (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and the IVD Regulation (EU) 2017/746, economic operators are the manufacturer, the authorized representative, the importer and the distributor. Each has its own obligations: manufacturer (Article 10), authorized representative (Article 11), importer (Article 13) and distributor (Article 14).

EU · MDR · IVDR

Person responsible for regulatory compliance (PRRC)

Under Article 15 of the EU Medical Device Regulation (EU) 2017/745 and of the IVD Regulation (EU) 2017/746, the person responsible for regulatory compliance (PRRC) is a person with the required expertise whom manufacturers and authorized representatives must have available. The PRRC is responsible at least for checking conformity before release, keeping technical documentation and the declaration of conformity up to date, and fulfilling post-market surveillance and vigilance obligations.

EU · MDR · IVDR

Device classification (MDR)

Under the EU Medical Device Regulation (EU) 2017/745, device classification assigns each medical device to class I, IIa, IIb or III according to its intended purpose and inherent risks, using the 22 classification rules in Annex VIII. Class I includes the subgroups Is (sterile), Im (measuring function) and Ir (reusable surgical instruments).

EU · MDR

Rule 11: software classification (MDR)

Under Rule 11 of Annex VIII of the EU Medical Device Regulation (EU) 2017/745, software intended to provide information used to take decisions with diagnosis or therapeutic purposes is class IIa, rising to class IIb or III depending on the possible impact of those decisions, and software intended to monitor physiological processes is class IIa or IIb. All other software is class I.

EU · MDR

Medical device software (MDSW)

Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, medical device software (MDSW) is software intended by its manufacturer to be used, alone or in combination, for a purpose that falls within the definition of a medical device or an in vitro diagnostic medical device. The term is used in MDCG 2019-11, the guidance on qualification and classification of software.

EU · MDR · IVDR

General safety and performance requirements (GSPR)

Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, the general safety and performance requirements (GSPR) in Annex I are the requirements every device must meet, taking into account its intended purpose. Annex I has three chapters: general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.

EU · MDR · IVDR · Technical documentation

Technical documentation (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, technical documentation is the set of documents the manufacturer draws up and keeps up to date to show that a device conforms to the regulation. Annex II lists its content; Annex III sets out the technical documentation on post-market surveillance.

EU · MDR · IVDR · Technical documentation

Notified body (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, a notified body is a conformity assessment body designated by a member state authority under the regulation to carry out third-party conformity assessment of devices. Notified bodies are identified by a four-digit number and listed in the European Commission’s NANDO database.

EU · MDR · IVDR

Conformity assessment (MDR)

Under the EU Medical Device Regulation (EU) 2017/745, conformity assessment is the process that shows whether a device meets the regulation’s requirements before it is placed on the market. Article 52 sets the procedure per device class, using Annex IX (quality management system and assessment of technical documentation), Annex X (type examination) and Annex XI (production quality assurance or product verification).

EU · MDR

Unique Device Identification (UDI)

Under the EU Medical Device Regulation (EU) 2017/745 (Article 27) and IVD Regulation (EU) 2017/746 (Article 24), Unique Device Identification (UDI) is the system that identifies devices through a code made of a device identifier (UDI-DI) and a production identifier (UDI-PI). The UDI is assigned using the standards of an issuing entity designated by the Commission and is carried on the label in machine- and human-readable form.

EU · USA · MDR · IVDR

EUDAMED

EUDAMED is the European database on medical devices set up under Article 33 of the EU Medical Device Regulation (EU) 2017/745, which also serves the IVD Regulation (EU) 2017/746. It consists of modules for actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.

EU · MDR · IVDR

Clinical evaluation (MDR)

Under the EU Medical Device Regulation (EU) 2017/745, clinical evaluation is the systematic and planned process to continuously generate, collect, analyze and assess the clinical data on a device in order to verify its safety and performance, including its clinical benefits, when used as intended. It is required for every device class, follows Article 61 and Annex XIV Part A and is documented in a clinical evaluation report.

EU · MDR · Technical documentation

Clinical investigation (MDR)

Under the EU Medical Device Regulation (EU) 2017/745, a clinical investigation is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. Articles 62 to 82 and Annex XV set the requirements for its application, conduct, sponsor duties, safety reporting and results.

EU · MDR

Post-market surveillance (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, post-market surveillance is the set of activities by which manufacturers, together with other economic operators, proactively collect and review experience gained from devices they have placed on the market, in order to identify any need for corrective or preventive action. Every manufacturer must run a PMS system proportionate to the risk class, as part of its quality management system.

EU · MDR · IVDR

Post-market clinical follow-up (PMCF)

Under the EU Medical Device Regulation (EU) 2017/745, post-market clinical follow-up is a continuous process that updates the clinical evaluation, in which the manufacturer proactively collects and evaluates clinical data from the use of a CE-marked device within its intended purpose. It is planned in a PMCF plan and reported in a PMCF evaluation report under Annex XIV Part B.

EU · MDR

Periodic safety update report (PSUR)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the periodic safety update report is the document in which manufacturers of class IIa, IIb and III medical devices and of class C and D IVDs summarize the results and conclusions of their post-market surveillance data, with the rationale for and description of any preventive and corrective actions taken.

EU · MDR · IVDR · Technical documentation

Vigilance (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, vigilance is the system for reporting and analyzing serious incidents and field safety corrective actions concerning devices made available on the EU market. Manufacturers report serious incidents to the competent authorities within fixed deadlines, investigate them and inform users of corrective actions through field safety notices.

EU · MDR · IVDR

Summary of safety and clinical performance (SSCP)

Under the EU Medical Device Regulation (EU) 2017/745, the summary of safety and clinical performance is a public document that manufacturers of implantable and class III devices, other than custom-made or investigational devices, draw up for each device. It is validated by the notified body, made available through EUDAMED and written so that the intended user and, where relevant, the patient can understand it.

EU · MDR · IVDR · Technical documentation

Labeling and instructions for use (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the label and the instructions for use are the information supplied by the manufacturer with the device, as set out in Annex I Chapter III (Section 23 MDR, Section 20 IVDR). The label identifies the device and manufacturer and carries safety-relevant information; the instructions for use tell the user how to use the device safely and as intended.

EU · MDR · IVDR · Technical documentation

Drug-device combination (MDR Article 117)

Under the EU Medical Device Regulation (EU) 2017/745, a drug-device combination is a product that combines a medical device and a medicinal product. Where device and medicinal product form a single integral product intended exclusively for use in that combination and not reusable, such as a prefilled syringe or pen, it is regulated as a medicinal product under Directive 2001/83/EC, and Article 117 MDR requires the marketing authorization application to include evidence that the device part meets the relevant general safety and performance requirements.

EU · MDR · Pharma

MDCG guidance

MDCG guidance documents are endorsed by the Medical Device Coordination Group, the group of member-state experts established by Article 103 of the EU Medical Device Regulation (EU) 2017/745, which also acts under the IVDR. They explain how the MDR and IVDR are to be applied; they are not legally binding, but notified bodies and competent authorities use them as the reference interpretation.

EU · MDR · IVDR

Transition periods (MDR and IVDR)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the transition periods allow legacy devices covered by certificates or declarations under the former directives to be placed on the market for a limited time after the regulations became applicable, provided set conditions are met. As amended by Regulations (EU) 2023/607 and 2024/1860, they run until December 31, 2027, 2028 or 2029, depending on the risk class.

EU · MDR · IVDR

Targeted revision of the MDR and IVDR (proposal)

The targeted revision of the MDR and IVDR is a legislative proposal the European Commission made in December 2025 to simplify the EU Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 and to make them more proportionate and predictable. As of September 2026 it is in the legislative procedure and not applicable law.

EU · MDR · IVDR

AI in medical devices (MDR, IVDR and AI Act)

Under the EU AI Act (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744), an AI system that is a medical device or IVD, or a safety component of one, and that requires notified-body conformity assessment under the MDR or IVDR is a high-risk AI system under Article 6(1), because both regulations are listed in Annex I Section A. The AI Act requirements apply to such systems from August 2, 2028 and are assessed within the MDR or IVDR conformity assessment by the notified body.

EU · MDR · IVDR · AI

In Vitro Diagnostic Medical Devices Regulation (IVDR)

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 is the EU regulation that sets the requirements for placing in vitro diagnostic medical devices and their accessories on the EU market. It applies since May 26, 2022, replaced Directive 98/79/EC and introduced a risk-based classification into classes A to D, with notified-body involvement for all classes except non-sterile class A.

EU · IVDR

In vitro diagnostic medical device (IVD)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, an in vitro diagnostic medical device is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system intended by the manufacturer to be used in vitro to examine specimens derived from the human body, solely or principally to provide information on a physiological or pathological state, congenital impairments, predisposition, safety and compatibility with potential recipients, treatment response, or to define or monitor therapeutic measures. Specimen receptacles are also IVDs.

EU · IVDR

Device classification (IVDR)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, device classification assigns each IVD to one of four risk classes, A (lowest) to D (highest), by applying the seven classification rules of Annex VIII to the device’s intended purpose and inherent risks. The class determines the conformity assessment route and the depth of evidence and post-market obligations.

EU · IVDR

Performance evaluation (IVDR)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, performance evaluation is the assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. It follows Article 56 and Annex XIII, is documented in a performance evaluation report and is updated throughout the device’s life.

EU · IVDR · Technical documentation

Performance study (IVDR)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, a performance study is a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 set the requirements; studies that pose additional risks to subjects, such as interventional clinical performance studies, need authorization by the member states concerned.

EU · IVDR

Post-market performance follow-up (PMPF)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, post-market performance follow-up is a continuous process that updates the performance evaluation, in which the manufacturer proactively collects and evaluates performance and relevant scientific data from the use of a CE-marked device within its intended purpose. It is planned in a PMPF plan and reported in a PMPF evaluation report under Annex XIII Part B.

EU · IVDR

Companion diagnostic (IVDR)

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, a companion diagnostic is a device that is essential for the safe and effective use of a corresponding medicinal product, to identify, before or during treatment, patients who are most likely to benefit from it or who are likely to be at increased risk of serious adverse reactions. Companion diagnostics are class C, and the notified body must consult the European Medicines Agency or a national medicines authority on the device’s suitability for use with the medicinal product.

EU · IVDR · Pharma

In-house devices (MDR and IVDR Article 5(5))

Under Article 5(5) of the EU Medical Device Regulation (EU) 2017/745 and of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, devices manufactured and used only within health institutions established in the EU are exempt from most requirements of the regulations, provided set conditions are met. The general safety and performance requirements still apply.

EU · MDR · IVDR

ISO 13485

ISO 13485 is the international standard for quality management systems of organizations involved in the lifecycle of medical devices. It sets requirements for regulatory purposes: documented processes for design, production, supplier control, complaint handling, corrective action and post-market feedback, applied in proportion to risk.

Standards · MDR · IVDR

ISO 14971

ISO 14971 is the international standard for applying risk management to medical devices, including software and in vitro diagnostic devices. It defines a lifecycle process of risk analysis, risk evaluation, risk control, evaluation of overall residual risk against benefits, and the collection of production and post-production information.

Standards · MDR · IVDR

IEC 62304

IEC 62304 is the international standard for software life cycle processes of medical device software. It defines development, maintenance, software risk management, configuration management and problem resolution processes, scaled by software safety class A, B or C.

Standards · MDR · IVDR

IEC 62366-1

IEC 62366-1 is the international standard for applying usability engineering to medical devices. It requires a process to analyze, specify, design and evaluate the user interface so that risks related to use, in particular use errors, are identified and controlled.

Standards · MDR

IEC 60601-1

IEC 60601-1 is the international standard for the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is the general standard of the IEC 60601 family and is complemented by collateral standards (IEC 60601-1-x) and particular standards (IEC 60601-2-x).

Standards · MDR

IEC 81001-5-1

IEC 81001-5-1 is the international standard for security activities in the product life cycle of health software, including medical device software. It adds security requirements to the software development and maintenance processes, such as threat modeling, secure design and coding, security testing, vulnerability handling and security updates.

Standards · MDR · IVDR

ISO 10993-1

ISO 10993-1 is the international standard that sets the framework for the biological evaluation of medical devices within a risk management process. It requires manufacturers to assess the device's materials and body contact and to decide which data, such as chemical characterization, existing data or biological tests, are needed to evaluate biological safety.

Standards · MDR

ISO 14155

ISO 14155 is the international standard of good clinical practice for clinical investigations of medical devices in human subjects. It sets requirements for the design, conduct, recording and reporting of such investigations to protect the rights, safety and well-being of subjects and to ensure credible results.

Standards · MDR

ISO 15223-1

ISO 15223-1 is the international standard that specifies symbols for expressing information supplied by the manufacturer of a medical device, such as on labels and in instructions for use. Each symbol comes with a title and a description of its meaning and requirements for its use.

Standards · MDR · IVDR · Technical documentation

ISO 20417

ISO 20417 is the international standard for the information to be supplied by the manufacturer of a medical device or accessory. It specifies general requirements for identification, labels, instructions for use, other accompanying documents and their electronic forms.

Standards · MDR · IVDR · Technical documentation

ISO 15189

ISO 15189 is the international standard for quality and competence of medical laboratories. It sets requirements for impartiality, structure, resources, examination processes and the management system, and is the basis on which accreditation bodies accredit medical laboratories.

Standards · IVDR

ISO 20916

ISO 20916 is the international standard of good study practice for clinical performance studies of in vitro diagnostic medical devices using specimens from human subjects. It sets requirements for planning, conducting, recording and reporting such studies to protect subjects and to ensure reliable performance data.

Standards · IVDR

ISO 14644-1

ISO 14644-1 is the international standard for classifying the air cleanliness of cleanrooms and clean zones by airborne particle concentration. It defines ISO Class 1 to ISO Class 9 by maximum particle concentrations for particle sizes from 0.1 to 5 µm and specifies how classification tests are performed.

Standards · GxP · Pharma

ISO 11135 and ISO 11137

ISO 11135 and ISO 11137 are the international standards for the development, validation and routine control of sterilization processes for health care products: ISO 11135 for ethylene oxide, ISO 11137 for radiation such as gamma, electron beam and X-ray. They require the process to be validated because sterility can't be verified by testing the finished product.

Standards · MDR · Pharma

GxP

GxP is the umbrella term for the good practice regulations and guidelines that govern the development, testing, manufacture, distribution and monitoring of medicinal products, with the x standing for a specific field such as manufacturing (GMP), clinical (GCP) or laboratory (GLP). What unites them is the demand that quality, patient safety and data reliability be demonstrated by controlled processes and records.

GxP · Pharma

Good manufacturing practice (GMP)

Good manufacturing practice (GMP) is the part of quality assurance that ensures medicinal products and active substances are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing or clinical trial authorization. In the EU it is laid down in Directive (EU) 2017/1572 and detailed in EudraLex Volume 4.

GxP · Pharma · EU · USA

Qualified Person (EU GMP)

Under Directive 2001/83/EC, the Qualified Person (QP) is the person whom every holder of an EU manufacturing or import authorization must have permanently and continuously available, and who certifies each batch of a medicinal product before it is released for sale or supply. The QP confirms that the batch was manufactured and checked in accordance with EU GMP and its marketing authorization.

GxP · Pharma · EU

Good distribution practice (GDP)

Good distribution practice (GDP) is the part of quality assurance that ensures the quality and integrity of medicinal products are maintained throughout the supply chain, from the manufacturer's release to the pharmacy or other person authorized to supply the public. In the EU it is set out in the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).

GxP · Pharma · EU

Good laboratory practice (GLP)

Good laboratory practice (GLP) is a quality system for the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. It is defined in the OECD Principles of Good Laboratory Practice (1997), applied in the EU through Directive 2004/10/EC and in the USA through 21 CFR Part 58.

GxP · Pharma

Good clinical practice (GCP)

Good clinical practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human participants. It protects the rights, safety and well-being of participants and the reliability of trial results; for medicinal products it is set out in ICH E6(R3), for medical devices in ISO 14155.

GxP · Pharma

Good pharmacovigilance practices (GVP)

Good pharmacovigilance practices (GVP) are the EU guidelines, organized in modules, on how marketing authorization holders, EMA and national authorities detect, assess, understand and prevent adverse effects of medicinal products. Their legal basis is Regulation (EC) No 726/2004, Directive 2001/83/EC and Implementing Regulation (EU) No 520/2012.

GxP · Pharma · EU

Good engineering practice (GEP)

Good engineering practice (GEP) is the use of established engineering methods and standards across the lifecycle of equipment and facilities to deliver solutions that are appropriate, cost-effective and documented. In the pharmaceutical industry it is described in the ISPE Good Practice Guide: Good Engineering Practice; it is not legally mandated by name but forms the basis on which GMP-critical aspects are then qualified.

GxP · Pharma

Good documentation practice (GDocP)

Good documentation practice (GDocP) is the set of rules for creating, reviewing, correcting and retaining GxP documents and records so that they are attributable, legible, contemporaneous, original and accurate. It is not a separate regulation but is derived from EU GMP Chapter 4 and from the data integrity guidance of MHRA, PIC/S, FDA and WHO.

GxP · Data integrity · Technical documentation

GAMP 5

German: GAMP 5

GAMP 5 is the ISPE guide “A Risk-Based Approach to Compliant GxP Computerized Systems”, whose second edition was published in July 2022. It describes a lifecycle approach to specifying, verifying, operating and retiring computerized systems used in GxP work, scaled to risk, system complexity and supplier involvement.

GxP · Pharma

Computerized system validation (CSV) and computer software assurance (CSA)

Computerized system validation (CSV) is the documented evidence that a computerized system used in GxP work does what it is intended to do, reliably and consistently, throughout its lifecycle. Computer software assurance (CSA) is the risk-based approach described in the FDA guidance “Computer Software Assurance for Production and Quality System Software”, finalized in September 2025, which directs assurance effort to software features that affect product quality and patient safety instead of exhaustive scripted testing.

GxP · Pharma · USA

Qualification: DQ, IQ, OQ and PQ

Under EU GMP Annex 15, qualification is the documented proof that premises, equipment, utilities and systems are properly designed, installed and work as intended. It proceeds in stages: design qualification (DQ) against user requirements, installation qualification (IQ), operational qualification (OQ) across the intended operating ranges, and performance qualification (PQ) under routine conditions.

GxP · Pharma

Process validation

Process validation is the documented evidence that a manufacturing process, operated within established parameters, consistently produces a product meeting its predetermined specifications and quality attributes. In pharma it is required by EU GMP (Annex 15) and US cGMP; for medical devices, ISO 13485 requires validation of processes whose output cannot be or is not verified by subsequent monitoring or measurement.

GxP · Pharma · MDR

Corrective and preventive action (CAPA)

Corrective and preventive action (CAPA) is the quality system process for investigating nonconformities, deviations, complaints and other quality problems, eliminating their causes to prevent recurrence (corrective action) and eliminating the causes of potential problems before they occur (preventive action). It is required in medical device quality management systems under ISO 13485 and the MDR and in the pharmaceutical quality system described in ICH Q10 and EU GMP.

GxP · MDR · Pharma

EU GMP Annex 1 (sterile medicinal products)

EU GMP Annex 1 is the annex of EudraLex Volume 4 on the manufacture of sterile medicinal products. Its revised version of 2022 applies since August 25, 2023 (one point on lyophilizers since August 25, 2024) and requires, among other things, a site-wide contamination control strategy (CCS) based on quality risk management.

GxP · Pharma · EU

EU GMP Annex 11 (computerized systems)

EU GMP Annex 11 is the annex of EudraLex Volume 4 that applies to all computerized systems used as part of GMP-regulated activities. It requires that such systems be validated and that their use does not reduce product quality, process control or quality assurance compared with a manual system, with risk management applied throughout the lifecycle. The version in force dates from 2011.

GxP · Pharma · EU · Data integrity

EU GMP Annex 15 (qualification and validation)

EU GMP Annex 15 is the annex of EudraLex Volume 4 that sets out the principles of qualification and validation for the facilities, equipment, utilities and processes used to manufacture medicinal products. The version in force dates from 2015 and asks that the scope and extent of qualification and validation be based on a justified and documented risk assessment.

GxP · Pharma · EU

EU GMP Annex 22 (artificial intelligence, draft)

EU GMP Annex 22 is a draft annex to EudraLex Volume 4, published for consultation in July 2025 by the European Commission, EMA and PIC/S, on artificial intelligence and machine learning models used in computerized systems in the manufacture of medicines and active substances where they affect patient safety, product quality or data integrity. The draft is limited to static, deterministic models and excludes dynamic, continuously learning models and generative AI or large language models from critical applications.

GxP · Pharma · EU · AI

Data integrity (GxP)

German: Datenintegrität

In GxP regulation, data integrity is the extent to which data are complete, consistent, accurate and trustworthy, and remain so throughout the data lifecycle, from creation through processing, review, reporting and archiving to destruction. It applies to paper, electronic and hybrid records alike.

GxP · Data integrity

ALCOA+

In GxP data integrity guidance, ALCOA+ is the set of attributes a record must have to be reliable: attributable, legible, contemporaneous, original and accurate (ALCOA), plus complete, consistent, enduring and available. Some guidance adds traceable, sometimes called ALCOA++.

GxP · Data integrity

21 CFR Part 11 (electronic records and signatures)

21 CFR Part 11 is the US FDA regulation, in effect since 1997, that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and generally equivalent to paper records and handwritten signatures. It applies to records required by other FDA regulations, such as drug and device GMP rules.

GxP · Data integrity · USA

International Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international association of medicines regulators and pharmaceutical industry bodies that develops harmonized guidelines on the quality, safety and efficacy of medicines. Its guidelines become binding expectations once regional regulators such as EMA and FDA implement them.

ICH · Pharma

ICH Q7 (GMP for active pharmaceutical ingredients)

ICH Q7 is the ICH guideline on good manufacturing practice for active pharmaceutical ingredients (APIs), adopted in 2000. It covers the manufacture of APIs from the point at which the API starting material enters the process and is implemented in the EU as Part II of EU GMP.

ICH · Pharma · GxP

ICH Q8(R2) (pharmaceutical development)

ICH Q8(R2) is the ICH guideline on pharmaceutical development, in its second revision since 2009. It describes how the development section of a marketing authorization dossier presents product and process knowledge and introduces quality by design, including the quality target product profile, critical quality attributes, design space and control strategy.

ICH · Pharma

ICH Q9(R1) (quality risk management)

ICH Q9(R1) is the ICH guideline on quality risk management for medicines, first revision adopted in January 2023. It describes a systematic process to assess, control, communicate and review risks to product quality across the product lifecycle, with the protection of the patient as the ultimate aim.

ICH · Pharma · GxP

ICH Q10 (pharmaceutical quality system)

ICH Q10 is the ICH guideline, adopted in 2008, that describes a model pharmaceutical quality system (PQS) for the whole product lifecycle, from development and technology transfer through commercial manufacturing to product discontinuation. It builds on GMP and ISO quality management concepts and complements ICH Q8 and Q9.

ICH · Pharma · GxP

ICH Q12 (product lifecycle management)

ICH Q12 is the ICH guideline on the technical and regulatory considerations for pharmaceutical product lifecycle management, adopted in 2019. It provides tools to manage chemistry, manufacturing and controls changes after approval more predictably, notably established conditions, post-approval change management protocols and the product lifecycle management document.

ICH · Pharma

ICH Q2(R2) and Q14 (analytical procedures)

ICH Q2(R2) and ICH Q14 are companion ICH guidelines on analytical procedures for medicines, both adopted in November 2023. Q14 covers the science- and risk-based development of analytical procedures and their lifecycle; Q2(R2) covers the validation of analytical procedures used for release and stability testing.

ICH · Pharma

ICH E6(R3) (good clinical practice)

ICH E6(R3) is the third revision of the ICH guideline for good clinical practice in clinical trials of medicines, adopted by ICH on January 6, 2025 and effective at EMA since July 23, 2025. It sets principles and responsibilities for sponsors, investigators and ethics committees to protect trial participants and to ensure reliable trial results, with a risk-proportionate approach.

ICH · Pharma · GxP

Common Technical Document (CTD, ICH M4)

The Common Technical Document (CTD), defined in ICH guideline M4, is the harmonized format for the quality, nonclinical and clinical information in marketing authorization applications for medicines. It is organized in five modules; module 1 holds regional administrative information, modules 2 to 5 are common across ICH regions.

ICH · Pharma · Technical documentation

Quality Management System Regulation (QMSR, 21 CFR Part 820)

The Quality Management System Regulation (QMSR) is the amended FDA regulation at 21 CFR Part 820 that sets quality system requirements for medical device manufacturers in the USA. Effective February 2, 2026, it incorporates ISO 13485:2016 by reference, adds FDA-specific requirements, and replaces the former Quality System Regulation (QSR).

USA · Standards

FDA premarket pathways: 510(k), De Novo and PMA

The FDA premarket pathways are the routes by which a medical device reaches the US market. A 510(k) shows substantial equivalence to a legally marketed predicate device, a De Novo request classifies a novel low- or moderate-risk device without a predicate, and premarket approval (PMA) is required for most class III devices on the basis of valid scientific evidence of safety and effectiveness.

USA

Drug cGMP (21 CFR Parts 210 and 211)

Drug cGMP are the US FDA's current good manufacturing practice regulations for medicines, set out in 21 CFR Part 210 (general provisions) and Part 211 (finished pharmaceuticals). They set minimum requirements for the methods, facilities and controls used to manufacture, process, pack or hold a drug; a drug not made in conformity with cGMP is deemed adulterated under the FD&C Act.

USA · GxP · Pharma

Predetermined change control plan (PCCP)

A predetermined change control plan (PCCP) is a plan, authorized by the US FDA as part of a device's marketing submission under section 515C of the FD&C Act, that describes specific planned modifications to the device and how they will be developed, validated and implemented. Modifications made in line with the authorized PCCP don't need a new marketing submission.

USA · AI