Glossary
MDR and medical device quality glossary
Short, precise definitions of the terms used in EU MDR technical documentation and ISO 13485 quality work. Each entry explains why the term matters and links to the workflow and guides where it is applied.
Terms
CAPA
Corrective and preventive action
Definition. The QMS process to eliminate the causes of existing nonconformities (corrective) and potential nonconformities (preventive), required by ISO 13485 clauses 8.5.2 and 8.5.3.
Why it matters. CAPA shows whether the QMS learns from problems; overdue or ineffective CAPAs are frequent audit findings.
Related workflow. CAPA software
Read more. Medical Device CAPA Guide
CER
Clinical evaluation report
Definition. The report documenting the clinical evaluation of a device: the clinical data identified, their appraisal and analysis, and the conclusion on safety, performance and benefit-risk.
Why it matters. It is part of Annex II Section 6 and is assessed by the notified body, often using the MDCG 2020-13 template.
Related workflow. Clinical evaluation software
Read more. Clinical Evaluation Report (CER) Guide
Clinical evaluation
Definition. The systematic and planned process to continuously generate, collect, analyse and assess clinical data on a device to verify its safety and performance, including clinical benefits (MDR Article 2(44)).
Why it matters. Article 61 requires it for every device, proportionate to the device and its risks, and it must be updated over the lifecycle.
Related workflow. Clinical evaluation software
Read more. Clinical Evaluation Report (CER) Guide · PMS and PMCF Explained
GSPR
General Safety and Performance Requirements
Definition. The requirements in MDR Annex I that every device must meet, covering general safety and performance, design and manufacture, and information supplied with the device.
Why it matters. The GSPR checklist in the technical documentation shows how each applicable requirement is met and where the evidence is.
Related workflow. GSPR compliance
Read more. What Is GSPR Compliance? · MDR Annex II and Annex III Explained
ISO 13485
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
Definition. The international QMS standard for organisations involved in the medical device lifecycle. It was confirmed in its 2025 systematic review and remains the current edition.
Why it matters. EN ISO 13485 is the harmonised standard most manufacturers use to demonstrate the MDR QMS requirements.
Related workflow. ISO 13485 software
Read more. ISO 13485 for Medical Device Manufacturers
ISO 14971
ISO 14971:2019 Medical devices — Application of risk management to medical devices
Definition. The international standard that specifies the risk management process for medical devices across the lifecycle, from planning to post-production.
Why it matters. EN ISO 14971:2019+A11:2021 is used to demonstrate the risk management requirements of MDR Annex I.
Related workflow. ISO 14971 software
Read more. ISO 14971 Risk Management Guide
IVDR
In Vitro Diagnostic Medical Devices Regulation, Regulation (EU) 2017/746
Definition. The EU regulation for in vitro diagnostic devices such as reagents, analysers and specimen containers. It has its own classification rules and performance evaluation requirements.
Why it matters. IVD manufacturers follow IVDR, not MDR. MDRpilot is built for MDR devices; IVDR is outside its regulatory content.
Related workflow. EU MDR software (scope)
Read more. What Is EU MDR 2017/745?
MDR
Medical Device Regulation, Regulation (EU) 2017/745
Definition. The EU regulation that governs medical devices and their accessories. It has applied since 26 May 2021 and replaced the MDD and AIMDD directives.
Why it matters. It defines who may place devices on the EU market and what documentation, systems and evidence they must maintain.
Related workflow. MDR software
Read more. What Is EU MDR 2017/745? · Software for the obligations in Regulation (EU) 2017/745
Notified body
Definition. An organisation designated by an EU Member State to assess the conformity of devices before they are placed on the market. Designated bodies are listed in the European Commission's NANDO database.
Why it matters. Except for most Class I devices, a notified body certificate is required before CE marking under MDR.
Related workflow. Audit readiness
Read more. MDR Audit Preparation Checklist · Medical device compliance software for the whole device lifecycle
PMCF
Post-market clinical follow-up
Definition. The continuous process, described in MDR Annex XIV Part B, of proactively collecting and evaluating clinical data on a CE-marked device used within its intended purpose.
Why it matters. It confirms safety and performance over the device lifetime and closes clinical gaps left at certification; it is required unless justified otherwise.
Related workflow. PMS and PMCF software
Read more. PMS and PMCF Explained · Clinical Evaluation Report (CER) Guide
PMS
Post-market surveillance
Definition. All activities a manufacturer carries out to collect and review experience from devices on the market, to identify the need for corrective or preventive action (MDR Articles 83–86).
Why it matters. PMS findings must feed the risk file, clinical evaluation and periodic reports; a device-specific PMS plan is part of the technical documentation.
Related workflow. PMS and PMCF software
Read more. PMS and PMCF Explained
Post-market surveillance system
Definition. The system required by MDR Article 83, integrated into the QMS and proportionate to the device risk class, that gathers, records and analyses data on quality, performance and safety throughout the device's lifetime.
Why it matters. Auditors check that the system exists, that it is actually run and that its conclusions lead to action.
Related workflow. PMS and PMCF software
Read more. PMS and PMCF Explained · CAPA software that closes the loop with complaints, audits and risk
PSUR
Periodic safety update report
Definition. A report required by MDR Article 86 for Class IIa, IIb and III devices that summarises PMS data, conclusions and actions. Class IIb and III devices update it at least annually, Class IIa at least every two years.
Why it matters. For Class III and implantable devices it is submitted to the notified body through EUDAMED and reviewed.
Related workflow. PMS and PMCF software
Read more. PMS and PMCF Explained
QMS
Quality management system
Definition. The organisational structure, responsibilities, procedures, processes and resources a manufacturer uses to achieve quality and regulatory compliance. MDR Article 10(9) lists the aspects it must cover.
Why it matters. The notified body assesses the QMS as part of conformity assessment for most devices.
Related workflow. Medical device QMS
Read more. ISO 13485 for Medical Device Manufacturers · ISO 13485 software for quality manuals, procedures and controlled records
Risk management
Definition. The systematic application of management policies, procedures and practices to analysing, evaluating, controlling and monitoring risk (ISO 14971). MDR Annex I Section 3 requires a risk management system for every device.
Why it matters. Risk management links design, verification, labelling and post-market data; it is reviewed in every technical documentation assessment.
Related workflow. ISO 14971 software
Read more. ISO 14971 Risk Management Guide · GSPR compliance with evidence you can trace
Technical documentation
Definition. The documents described in MDR Annexes II and III that demonstrate a device's conformity: description, labelling, design and manufacturing, GSPR, risk, verification and validation, and PMS.
Why it matters. It is reviewed by the notified body for devices that need one, and must be kept up to date and available to authorities.
Related workflow. Technical file software
Read more. EU MDR Technical Documentation: Complete Guide · MDR technical documentation under Annex II and Annex III
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.