Product Devices Glossary
The gcrs group Product Devices Glossary explains the regulatory, technical and quality management terminology used throughout the cosmetic device and medical device sectors. Whether you are developing, manufacturing or placing cosmetic devices, beauty technology or medical devices on the UK, EU, USA or other international markets, this glossary provides a practical reference to support product compliance and successful market access.
The glossary covers terminology relating to cosmetic devices, beauty technology, medical devices, product classification, conformity assessment, technical documentation, quality management systems, clinical evaluation, risk management, post-market surveillance, international regulatory authorities and globally recognised safety standards. It has been developed as a valuable resource for manufacturers, brand owners, importers, distributors and regulatory professionals navigating the increasingly complex regulatory landscape for product devices across global markets.
A
An Accessory for a Medical Device is a product that is not itself a medical device but is specifically intended by the manufacturer to be used together with one or more medical devices to enable them to function as intended or to directly support their medical purpose. Accessories are generally regulated under the same legislation as the associated medical device and may require conformity assessment before being placed on the market.
Related terms: Medical Device, Medical Device Regulation (MDR), Technical Documentation
An Active Medical Device is a medical device that relies on electrical energy, batteries or another external power source to perform its intended medical function. Examples include infusion pumps, patient monitoring systems, diagnostic imaging equipment and laser devices. Active devices are subject to additional electrical, performance and safety requirements depending on their classification and intended purpose.
Related terms: Electrical Safety, EMC Testing, Risk Assessment
An Authorised Representative is a natural or legal person established within a regulatory jurisdiction who acts on behalf of a medical device manufacturer located outside that jurisdiction. The representative supports regulatory compliance, maintains communication with competent authorities and may retain technical documentation and regulatory records where required by legislation.
Related terms: Manufacturer, Medical Device Regulation (MDR), Declaration of Conformity
B
A Beauty Device is an electronic, mechanical or manual product intended to improve or maintain the appearance of the skin, hair or body through cosmetic or aesthetic treatments. Depending on its intended purpose and marketing claims, a beauty device may be regulated as a cosmetic product, a medical device or a general consumer product. Correct regulatory classification is essential before market entry.
Related terms: Cosmetic Device, Borderline Product, Product Classification
A Borderline Product is a product whose regulatory status is not immediately clear because its intended purpose, claims or mode of action may place it between two or more regulatory categories, such as cosmetics, medical devices, medicinal products or general consumer products. Regulatory authorities assess borderline products on a case-by-case basis.
Related terms: Product Classification, Intended Purpose, Cosmetic Device
C
Corrective and Preventive Action (CAPA) is a structured quality management process used to investigate non-conformities, identify their root causes and implement actions that prevent recurrence. CAPA forms a core element of medical device quality management systems and supports continuous improvement, regulatory compliance and product safety.
Related terms: Quality Management System (QMS), Root Cause Analysis, Risk Management
CE Marking indicates that a medical device complies with the applicable European Union regulatory requirements before being placed on the EU market. Depending on the device classification, manufacturers may require assessment by a Notified Body before applying the CE mark. CE Marking demonstrates conformity with the Medical Device Regulation (MDR), IVDR and other applicable legislation where required.
Related terms: Declaration of Conformity, Medical Device Regulation (MDR), Notified Body
Change Control is the documented process used to evaluate, approve, implement and record changes that may affect a medical device, manufacturing process, software, labelling or quality management system. Effective change control ensures that modifications are assessed for regulatory impact and do not compromise product safety, quality or compliance.
Related terms: CAPA, Quality Management System (QMS), Technical Documentation
Clinical Evaluation is the systematic assessment of clinical evidence demonstrating that a medical device achieves its intended purpose while maintaining an acceptable level of safety and performance. Clinical evaluation is a continuous regulatory requirement throughout the product lifecycle and must be updated as new evidence becomes available.
Related terms: Clinical Evidence, PMCF (Post-Market Clinical Follow-up), Medical Device Regulation (MDR)
Clinical Evidence is the collection of clinical data and scientific information demonstrating that a medical device performs as intended while maintaining an acceptable level of safety. Clinical evidence may be generated through clinical investigations, published literature, equivalent devices and post-market clinical follow-up activities.
Related terms: Clinical Evaluation, Clinical Investigation, PMCF (Post-Market Clinical Follow-up)
A Clinical Investigation is a systematic study involving human participants conducted to evaluate the safety, clinical performance and effectiveness of a medical device. Clinical investigations provide evidence to support regulatory submissions, product development and ongoing compliance with medical device legislation.
Related terms: Clinical Evaluation, Clinical Evidence, Medical Device Regulation (MDR)
Complaint Handling is the documented process used to receive, investigate, evaluate and resolve complaints relating to the safety, quality or performance of medical devices. Manufacturers must assess complaints to determine whether corrective action, vigilance reporting or product improvements are required.
Related terms: CAPA, Vigilance Reporting, Post-Market Surveillance
A Competent Authority is the government body responsible for implementing and enforcing medical device legislation within a particular country or jurisdiction. Competent Authorities oversee manufacturer compliance, market surveillance, product registration, vigilance reporting and regulatory enforcement activities.
Related terms: MHRA, Market Surveillance, Vigilance Reporting
Conformity Assessment is the process used to demonstrate that a medical device satisfies all applicable regulatory requirements before being placed on the market. Depending on the device classification, conformity assessment may involve internal quality procedures or independent review by a Notified Body.
Related terms: CE Marking, Declaration of Conformity, Notified Body
A Cosmetic Device is a product intended solely to improve or maintain a person’s appearance without making medical claims. Examples include facial cleansing brushes, LED beauty devices and skin massage equipment. Regulatory requirements vary depending on the intended purpose, technology used and marketing claims made by the manufacturer.
Related terms: Beauty Device, Borderline Product, Product Classification
D
A Declaration of Conformity (DoC) is a formal legal document issued by a manufacturer confirming that a medical device complies with all applicable regulatory requirements before being placed on the market. The declaration demonstrates that the manufacturer has completed the appropriate conformity assessment procedures and prepared the required technical documentation. It is a mandatory requirement for CE Marking and UKCA Marking and must be made available to regulatory authorities upon request.
Related terms: CE Marking, UKCA Marking, Technical Documentation
Design Validation is the documented process of confirming that a finished medical device fulfils its intended purpose and meets the needs of its intended users under actual or simulated conditions of use. Validation provides objective evidence that the device performs safely and effectively before commercial release and supports regulatory approval.
Related terms: Design Verification, Intended Purpose, Risk Assessment
Design Verification is the process of confirming that design outputs satisfy the specified design input requirements established during product development. Verification activities may include inspections, laboratory testing, engineering analysis and document reviews to demonstrate that the product has been designed correctly before validation begins.
Related terms: Design Validation, Technical Documentation, Risk Assessment
A Device History Record (DHR) is the documented evidence demonstrating that an individual medical device or production batch has been manufactured in accordance with the approved Device Master Record and quality management procedures. The DHR typically includes production records, inspection results, testing documentation and release approvals that support product traceability and regulatory compliance.
Related terms: Device Master Record (DMR), Quality Management System (QMS), Technical Documentation
A Device Master Record (DMR) is the complete collection of documents and specifications required to consistently manufacture a medical device. It typically contains product drawings, manufacturing instructions, quality procedures, packaging specifications, labelling information and acceptance criteria used throughout production.
Related terms: Device History Record (DHR), Technical Documentation, Design Verification
A Distributor is a natural or legal person within the supply chain, other than the manufacturer or importer, who makes a medical device available on the market. Distributors are responsible for ensuring that products bear the correct conformity markings, are accompanied by the required documentation and have been stored and transported in accordance with the manufacturer’s instructions.
Related terms: Importer, CE Marking, Market Surveillance
E
Electrical Safety refers to the measures implemented to ensure that electrically powered medical devices operate safely without creating unacceptable risks to patients, users or healthcare professionals. Manufacturers must demonstrate compliance through testing and risk management to verify protection against electric shock, overheating, electrical faults and other hazards before products are placed on the market.
Related terms: EMC Testing, Low Voltage Directive (LVD), Risk Assessment
Electromagnetic Compatibility (EMC) Testing evaluates whether a medical device can operate correctly within its intended electromagnetic environment without causing or being affected by electromagnetic interference. EMC testing is essential for ensuring the safe and reliable performance of electronic medical devices and forms part of regulatory conformity assessment.
Related terms: Electrical Safety, CE Marking, Technical Documentation
Essential Principles are the fundamental safety and performance requirements adopted within several international medical device regulatory frameworks. They establish the baseline criteria that manufacturers must satisfy to demonstrate that a medical device is safe, performs as intended and meets applicable regulatory obligations before being placed on the market.
Related terms: General Safety and Performance Requirements (GSPR), Risk Management, Technical Documentation
The European Database on Medical Devices (EUDAMED) is the European Union’s central electronic database supporting the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). It improves transparency and traceability by providing information relating to manufacturers, authorised representatives, device registrations, certificates, clinical investigations and vigilance activities.
Related terms: UDI (Unique Device Identifier), Medical Device Regulation (MDR), Market Surveillance
F
FDA Medical Device Regulations establish the legal framework governing the manufacture, marketing and distribution of medical devices within the United States. Devices are regulated according to their risk classification, with manufacturers required to comply with applicable requirements relating to quality systems, product registration, premarket submissions, labelling and post-market surveillance before commercial distribution.
Related terms: Medical Device, UDI (Unique Device Identifier), Quality Management System (QMS)
A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer to reduce or eliminate the risk of serious incidents associated with a medical device that has already been placed on the market. FSCAs may include product recalls, software updates, field modifications, revised Instructions for Use or safety notices issued to customers.
Related terms: Vigilance Reporting, Product Recall, Post-Market Surveillance
G
The General Product Safety Regulation (GPSR) establishes safety requirements for consumer products placed on the European Union market that are not fully covered by sector-specific legislation or where additional consumer safety obligations apply. Although most medical devices are regulated under dedicated medical device legislation, certain accessories, connected products or consumer products may also fall within the scope of the GPSR depending on their intended purpose and regulatory classification.
Related terms: Product Classification, Market Surveillance, Intended Purpose
The General Safety and Performance Requirements (GSPR) are the core safety and performance requirements contained within the EU Medical Device Regulation (MDR). Manufacturers must demonstrate that their medical devices satisfy these requirements relating to design, construction, risk management, clinical evidence, usability and product performance before CE Marking can be applied.
Related terms: Medical Device Regulation (MDR), Risk Assessment, Technical Documentation
Good Documentation Practice (GDP) refers to the principles governing the creation, review, approval, maintenance and storage of regulatory and quality documentation. GDP ensures that records remain accurate, complete, legible and traceable throughout the product lifecycle and supports regulatory inspections, audits and quality management activities.
Related terms: Technical Documentation, Quality Management System (QMS), CAPA
H
Human Factors Engineering is the process of designing medical devices to minimise user error and improve safety by considering how healthcare professionals, patients and other users interact with a product under real-world conditions. Human factors studies help manufacturers identify potential usability risks and optimise product design before market release.
Related terms: Usability Testing, Intended Purpose, Design Validation
I
An Importer is a natural or legal person established within a regulatory jurisdiction who places a medical device from another country onto that market. Importers have specific regulatory responsibilities, including verifying product conformity, ensuring appropriate documentation accompanies the device and cooperating with regulatory authorities when required.
Related terms: Distributor, Authorised Representative, Market Surveillance
Intended Purpose is the specific medical use or function assigned to a product by its manufacturer based on the product’s labelling, Instructions for Use, technical documentation and promotional material. Intended purpose is one of the most important factors used by regulatory authorities when determining product classification and the applicable regulatory pathway.
Related terms: Product Classification, Borderline Product, Medical Device
ISO 10993 is the internationally recognised series of standards governing the biological evaluation of medical devices. It provides manufacturers with a structured framework for assessing the biocompatibility of materials that come into direct or indirect contact with the human body, helping demonstrate that products are safe for their intended use.
Related terms: Risk Assessment, Clinical Evaluation, Technical Documentation
ISO 13485 is the internationally recognised quality management system standard developed specifically for organisations involved in the design, manufacture and distribution of medical devices. It establishes requirements for quality management processes that support regulatory compliance, product consistency and continual improvement throughout the product lifecycle.
Related terms: Quality Management System (QMS), ISO 14971, CAPA
ISO 14971 is the internationally recognised standard specifying the process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle. It provides manufacturers with a systematic framework for implementing effective risk management as part of regulatory compliance.
Related terms: Risk Assessment, Risk Management, Quality Management System (QMS)
The In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 establishes the regulatory framework governing in vitro diagnostic medical devices within the European Union. The regulation introduces enhanced requirements for product classification, performance evaluation, clinical evidence, conformity assessment, technical documentation and post-market surveillance to improve patient safety and regulatory oversight.
Related terms: Medical Device Regulation (MDR), Performance Evaluation, CE Marking
L
Labelling Requirements are the regulatory rules governing the information that must appear on a medical device and its packaging before it is placed on the market. Depending on the jurisdiction, labels may include the manufacturer’s details, intended purpose, warnings, symbols, Unique Device Identifier (UDI), storage conditions and other mandatory information required for safe use.
Related terms: User Instructions (IFU), UDI (Unique Device Identifier), Product Classification
The Low Voltage Directive (LVD) establishes safety requirements for electrical equipment operating within specified voltage limits in the European Union. Although most medical devices are regulated primarily under the Medical Device Regulation (MDR), certain electrical equipment or accessories may also need to demonstrate compliance with the LVD where applicable.
Related terms: Electrical Safety, EMC Testing, CE Marking
M
A Manufacturer is the natural or legal person responsible for designing, manufacturing, refurbishing or having a medical device designed and manufactured before placing it on the market under its own name or trademark. The manufacturer is ultimately responsible for ensuring the device complies with all applicable regulatory requirements, including conformity assessment, technical documentation, quality management and post-market obligations.
Related terms: Authorised Representative, Declaration of Conformity, Quality Management System (QMS)
Market Surveillance is the process undertaken by regulatory authorities to monitor medical devices that have been placed on the market and verify that they continue to comply with applicable regulatory requirements. Activities may include inspections, product testing, document reviews, complaint investigations and enforcement actions where non-compliance is identified.
Related terms: Post-Market Surveillance, Vigilance Reporting, MHRA
A Medical Device is an instrument, apparatus, software, implant, reagent or other product intended by the manufacturer for medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis or treatment of disease or injury. Unlike medicinal products, medical devices achieve their primary intended action through physical or mechanical means rather than pharmacological, immunological or metabolic action.
Related terms: Medical Device Regulation (MDR), Intended Purpose, Product Classification
The Medical Device Regulation (EU) 2017/745 is the primary legislation governing medical devices within the European Union. The MDR establishes comprehensive requirements covering product design, conformity assessment, clinical evaluation, quality management, technical documentation, post-market surveillance and vigilance reporting throughout the device lifecycle.
Related terms: CE Marking, General Safety and Performance Requirements (GSPR), Technical Documentation
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government authority responsible for regulating medicines and medical devices throughout Great Britain. The MHRA oversees medical device registration, market surveillance, vigilance reporting and regulatory enforcement to help ensure products remain safe and effective throughout their lifecycle.
Related terms: UKCA Marking, Market Surveillance, Vigilance Reporting
N
A Notified Body is an independent conformity assessment organisation designated by an EU Member State to assess whether certain medical devices comply with the Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR). Depending on device classification, manufacturers may require certification from a Notified Body before CE Marking can be applied.
Related terms: CE Marking, Declaration of Conformity, Medical Device Regulation (MDR)
P
Packaging Validation is the documented process of demonstrating that a medical device’s packaging system consistently protects the product during transportation, storage and normal handling. For sterile devices, validation also confirms that the sterile barrier system maintains sterility until the point of use.
Related terms: Sterile Barrier System, Design Validation, Technical Documentation
Performance Evaluation is the systematic process of collecting and assessing scientific, analytical and technical evidence demonstrating that an in vitro diagnostic medical device performs as intended throughout its lifecycle. Performance evaluation forms a core regulatory requirement under the In Vitro Diagnostic Medical Device Regulation (IVDR).
Related terms: IVDR, Clinical Evaluation, Technical Documentation
Post-Market Clinical Follow-up (PMCF) is the continuous process of collecting and evaluating clinical data after a medical device has been placed on the market. PMCF enables manufacturers to confirm long-term safety and performance, identify emerging risks and maintain compliance with the Medical Device Regulation throughout the product lifecycle.
Related terms: Clinical Evaluation, Clinical Evidence, Post-Market Surveillance
Post-Market Surveillance is the ongoing process of monitoring the safety, quality and performance of medical devices after they have been placed on the market. Manufacturers are required to collect and analyse information from product use, investigate incidents and implement corrective actions where necessary to maintain regulatory compliance.
Related terms: Market Surveillance, PMCF, Vigilance Reporting
Product Classification is the process of determining the appropriate regulatory category and risk classification for a product based on its intended purpose, mode of action, technology and manufacturer claims. Correct classification establishes which legislation applies and determines the regulatory pathway before market entry.
Related terms: Borderline Product, Intended Purpose, Cosmetic Device
Product Lifecycle refers to the complete sequence of activities associated with a medical device, beginning with concept and design, continuing through manufacture, regulatory approval, market placement, post-market surveillance and finally product withdrawal or disposal. Effective lifecycle management supports continuous compliance, product quality and patient safety.
Related terms: Product Stewardship, Post-Market Surveillance, Technical Documentation
A Product Recall is the action taken to remove or recover a medical device from the market when it presents an unacceptable risk to health or no longer complies with applicable regulatory requirements. Recalls may be initiated voluntarily by the manufacturer or required by a regulatory authority as part of market surveillance activities.
Related terms: Field Safety Corrective Action (FSCA), Vigilance Reporting, Market Surveillance
Product Registration is the process of submitting required information about a medical device to the relevant regulatory authority before or after the product is placed on the market, depending on the applicable legislation. Registration requirements vary between jurisdictions and may include manufacturer information, device details, conformity certificates and technical documentation.
Related terms: Regulatory Submission, UDI (Unique Device Identifier), Market Surveillance
Q
Quality Assurance (QA) comprises the planned and systematic activities implemented within a quality management system to ensure medical devices consistently meet regulatory requirements and predefined quality standards. QA supports product consistency, continuous improvement and compliance throughout the design, manufacturing, distribution and post-market phases of the product lifecycle.
Related terms: Quality Management System (QMS), ISO 13485, CAPA
A Quality Management System (QMS) is a structured framework of documented policies, procedures and processes that enables a medical device manufacturer to consistently design, manufacture and supply products that meet regulatory and customer requirements. A QMS supports continual improvement, risk management and compliance with international standards such as ISO 13485.
Related terms: ISO 13485, CAPA, Risk Management
R
A Regulatory Submission is the package of documentation submitted to a regulatory authority or conformity assessment body to demonstrate that a medical device complies with applicable legislative requirements. Depending on the jurisdiction, submissions may include technical documentation, clinical evidence, risk management files, quality management information and product registration details.
Related terms: Technical Documentation, Declaration of Conformity, Product Registration
Risk Assessment is the systematic process of identifying hazards, estimating and evaluating associated risks, implementing appropriate risk control measures and monitoring their effectiveness throughout a medical device’s lifecycle. Risk assessment forms a fundamental requirement under the Medical Device Regulation (MDR) and ISO 14971.
Related terms: ISO 14971, Risk Management, Technical Documentation
Risk Management is the ongoing process of identifying, evaluating, controlling and reviewing risks associated with a medical device throughout its entire lifecycle. Manufacturers must establish documented risk management procedures to demonstrate that product risks have been reduced as far as possible while maintaining the intended clinical benefits.
Related terms: Risk Assessment, ISO 14971, General Safety and Performance Requirements (GSPR)
Root Cause Analysis is a structured investigation process used to identify the underlying cause of a quality issue, product defect, complaint or regulatory non-conformity. Identifying the true root cause enables manufacturers to implement effective corrective and preventive actions that reduce the likelihood of recurrence and support continuous improvement.
Related terms: CAPA, Change Control, Quality Management System (QMS)
The Restriction of Hazardous Substances (RoHS) Directive limits the use of specific hazardous materials, including lead, mercury, cadmium and certain flame retardants, in electrical and electronic equipment. Depending on the product type, manufacturers of electrically powered medical devices may also need to demonstrate compliance with RoHS requirements.
Related terms: WEEE, Electrical Safety, CE Marking
S
Software as a Medical Device (SaMD) is software intended by the manufacturer to perform one or more medical purposes without being part of a physical medical device. Examples include diagnostic software, clinical decision support systems and medical imaging analysis applications. SaMD is regulated as a medical device where it meets the applicable regulatory definition.
Related terms: Medical Device, Intended Purpose, Product Classification
A Sterile Barrier System is the packaging configuration designed to maintain the sterility of a medical device until the point of use. Manufacturers must validate the packaging system to demonstrate that it protects the device from contamination during storage, transportation and normal handling throughout its intended shelf life.
Related terms: Packaging Validation, Sterilisation Validation, Technical Documentation
Sterilisation Validation is the documented process of demonstrating that a sterilisation method consistently achieves the required sterility assurance level for medical devices intended to be supplied sterile. Validation provides objective evidence that the sterilisation process is effective, repeatable and suitable for routine manufacturing.
Related terms: Sterile Barrier System, Packaging Validation, Quality Management System (QMS)
Supplier Qualification is the documented process used to assess, approve and monitor suppliers providing materials, components or services used in the manufacture of medical devices. Qualification activities help ensure suppliers consistently meet regulatory, quality and performance requirements throughout the supply chain.
Related terms: Quality Management System (QMS), Risk Assessment, Technical Documentation
T
Technical Documentation is the comprehensive collection of documents demonstrating that a medical device complies with applicable regulatory requirements throughout its lifecycle. It typically includes product specifications, design records, risk management documentation, verification and validation reports, clinical evidence, manufacturing information, labelling, Instructions for Use, post-market surveillance procedures and declarations of conformity. Regulatory authorities may request access to technical documentation during inspections or conformity assessments.
Related terms: Design Verification, Design Validation, Declaration of Conformity
Traceability is the ability to identify and follow a medical device throughout every stage of its lifecycle, from raw materials and manufacturing through distribution, clinical use and post-market monitoring. Effective traceability enables manufacturers and regulators to identify affected products quickly during safety investigations, corrective actions or product recalls.
Related terms: UDI (Unique Device Identifier), Product Lifecycle, Market Surveillance
Traceability Records are the documented information used to identify the manufacture, distribution and location of medical devices throughout their lifecycle. Maintaining accurate traceability records supports recalls, post-market surveillance, regulatory inspections and patient safety by enabling affected devices to be located quickly.
Related terms: UDI (Unique Device Identifier), Product Recall, Product Lifecycle
U
A Unique Device Identifier (UDI) is a globally recognised identification system that enables medical devices to be uniquely identified and traced throughout their lifecycle. UDI improves product traceability, supports post-market surveillance, facilitates product recalls and enhances patient safety by allowing manufacturers and regulatory authorities to identify individual devices efficiently.
Related terms: EUDAMED, Post-Market Surveillance, FDA Medical Device Regulations
UKCA (UK Conformity Assessed) Marking demonstrates that a medical device complies with the regulatory requirements applicable within Great Britain. Following the UK’s departure from the European Union, UKCA Marking has become the conformity marking required for many regulated products, subject to current transitional arrangements and guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA).
Related terms: MHRA, Declaration of Conformity, CE Marking
Instructions for Use (IFU) are the documents supplied with a medical device that explain its intended purpose, installation, operation, maintenance, warnings, precautions, contraindications and safe disposal. Clear and accurate IFUs help ensure devices are used safely and effectively while meeting applicable regulatory requirements.
Related terms: Intended Purpose, Labelling Requirements, Technical Documentation
Usability Engineering is the process of designing and evaluating medical devices to ensure they can be used safely, effectively and efficiently by their intended users within their intended environment. It focuses on reducing user error through human-centred design principles and forms an important part of risk management and product development.
Related terms: Human Factors Engineering, Design Validation, Intended Purpose
Usability Testing evaluates how intended users interact with a medical device to confirm that it can be operated safely, effectively and as intended. Testing identifies potential user errors, usability issues and opportunities for design improvements before commercial release.
Related terms: Human Factors Engineering, Design Validation, Risk Assessment
V
A Validation Master Plan (VMP) is a high-level document describing an organisation’s overall strategy, responsibilities and approach for validating manufacturing processes, equipment, software, utilities and quality systems. It establishes how validation activities will be planned, executed, documented and maintained to demonstrate ongoing regulatory compliance.
Related terms: Quality Management System (QMS), Design Validation, Technical Documentation
Verification is the process of confirming through objective evidence that specified design or manufacturing requirements have been fulfilled. Verification activities may include inspections, laboratory testing, engineering analysis or documentation reviews to demonstrate compliance with predefined specifications before product validation.
Related terms: Design Verification, Design Validation, Technical Documentation
Vigilance Reporting is the process of notifying the appropriate regulatory authority about serious incidents, adverse events and Field Safety Corrective Actions associated with medical devices after they have been placed on the market. Vigilance systems enable regulators and manufacturers to monitor product safety and implement appropriate corrective actions where necessary.
Related terms: Field Safety Corrective Action (FSCA), Post-Market Surveillance, Market Surveillance
W
The Waste Electrical and Electronic Equipment (WEEE) Directive establishes requirements for the environmentally responsible collection, recycling and disposal of electrical and electronic equipment. Manufacturers of applicable medical devices must comply with WEEE obligations relating to product labelling, producer responsibility and end-of-life waste management.
Related terms: RoHS, Electrical Safety, Product Lifecycle