MDCG Pre-Registration Assessment key terms

An instrument, apparatus, appliance, software or other article intended by the manufacturer for human use for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, whose principal intended action is not achieved by pharmacological, immunological or metabolic means.

A device intended by the manufacturer for the in vitro examination of specimens derived from the human body, solely or principally to provide information on physiological or pathological states, congenital anomalies, safety and compatibility, or therapeutic response monitoring.

An expert committee of national competent authority representatives established under MDR Article 103 and IVDR Article 99, issuing guidance, position papers and technical documents that interpret but do not legally replace the Regulations.

The ordering of interpretive material by legal weight: the MDR/IVDR text and delegated or implementing acts prevail, followed by MDCG guidance, then notified body position papers and team-NB documents, which carry no independent legal force.

The national body designated under MDR Article 101 or IVDR Article 96 that oversees market surveillance, vigilance reporting, clinical investigation authorisation and device registration within its member state, distinct from the notified body performing conformity assessment.

An independent conformity assessment body designated by a member state and notified to the Commission to assess whether a manufacturer's quality system and technical documentation satisfy the applicable annexes of the MDR or IVDR.

The use for which a device is intended according to the data supplied by the manufacturer on the label, in instructions for use or in promotional material, and the reference point for classification, clinical claims and conformity assessment scope.

One of the numbered criteria in MDR Annex VIII or IVDR Annex VIII that assigns a device to a risk class based on invasiveness, duration of contact, anatomical site, energy delivery or diagnostic consequence, applying the strictest applicable rule.

The lowest MDR risk class, covering non-invasive, short-duration devices with limited hazard, generally permitting self-declaration of conformity, except for surgical and reusable instruments and devices placed on the market sterile or with a measuring function.

An MDR risk class covering devices such as short-term invasive devices, long-term surgically invasive devices in certain sites, and diagnostic devices with moderate risk, requiring notified body involvement in conformity assessment.

An MDR risk class for higher-hazard devices including long-term surgically invasive devices, devices delivering ionising radiation, and devices intended to administer medicinal products, requiring notified body assessment of both quality system and technical documentation.

The highest MDR risk class, covering devices such as those with a medicinal product ancillary action, implantable devices in direct contact with the heart or central circulatory system, and devices with a substantial diagnostic or therapeutic impact.

The conformity assessment route in which the manufacturer issues the EU declaration of conformity and applies the CE marking without notified body involvement, permitted only for Class I devices that are not sterile and have no measuring function.

The demonstration, through a defined route in MDR Annex IX, X or XI or IVDR Annex IX, X or XI, that a device meets the applicable general safety and performance requirements before CE marking and placing on the market.

A document in which the manufacturer legally affirms that the device satisfies the applicable MDR or IVDR requirements, listing the device, the conformity assessment route applied and any notified body certificate number.

The symbol affixed to a device indicating conformity with applicable EU harmonisation legislation, allowing free movement within the internal market and accompanied by the notified body's four-digit identification number where one is involved.

The MDR Article 54 process in which the notified body submits its preliminary assessment of a Class III or certain Class IIb device to the competent authorities and Commission, who may request further review before certification.

The body of evidence in MDR Annex II and III or IVDR Annex II and III that demonstrates conformity, covering device description, design information, labelling, manufacturing, safety and performance requirements, risk analysis and verification and validation results.

The mandatory requirements in MDR Annex I or IVDR Annex I that a device must satisfy, covering design, risk control, performance, labelling and information supplied, and which the technical documentation must demonstrate conformity with.

The compilation of records produced under the manufacturer's risk management process, documenting hazard identification, risk estimation, risk control measures, residual risk evaluation and benefit-risk analysis across the device lifecycle.

The international standard specifying a risk management process for medical devices, covering hazard identification, risk estimation and evaluation, risk control, evaluation of overall residual risk and production and post-production monitoring.

The international standard for medical device quality management systems, specifying requirements for design and development, purchasing, production, monitoring and improvement, and used as the benchmark for notified body quality system audits.

The notified body assessment under MDR Annex IX that the manufacturer's quality management system adequately covers design, manufacture, inspection and post-market obligations, resulting in a certificate subject to surveillance audits.

The set of purchasing and evaluation activities, including supplier qualification, agreed specifications, incoming inspection and written quality agreements, by which a manufacturer ensures that purchased components and services do not compromise device conformity.

A supplier whose delivered product, process or service has a direct effect on device safety or performance, such as sterilisation services, contract manufacturers or software developers, requiring documented qualification and periodic re-evaluation.

The systematic and planned process in MDR Article 61 and Annex XIV to continuously generate, collect, appraise and analyse clinical data to verify the safety and performance, including clinical benefit, of a device.

The document recording the clinical evaluation's scope, literature and data appraisal, analysis and conclusions, forming part of the technical documentation and requiring update throughout the device lifecycle.

A systematic study involving human subjects intended to assess the safety or performance of a device, subject to MDR Articles 62 to 80 and Annex XV, requiring authorisation by the member state concerned.

The documented voluntary agreement of a subject to participate in a clinical investigation after receiving adequate information on its nature, objectives, risks, benefits and rights, as required by MDR Article 63 and Annex XV.

The IVDR process in Articles 56 and 57 and Annex XIII assessing scientific validity, analytical performance and clinical performance of an in vitro diagnostic device, supported by a performance evaluation report.

An IVDR study assessing analytical performance, clinical performance or scientific validity of an in vitro diagnostic device, including studies using leftover specimens, subject to the requirements of Articles 57 to 77 and Annex XIII.

The systematic and proactive collection and analysis of data from the market about device quality, performance and safety, used to update risk analysis, clinical evaluation and the technical documentation throughout the device lifetime.

The document required by MDR Article 84 and Annex III defining the methods, data sources, indicators, responsibilities and evaluation thresholds used to conduct post-market surveillance for a given device.

A report required by MDR Article 86 summarising post-market surveillance results, benefit-risk conclusions and any corrective actions, with frequency depending on device class and submitted to the notified body for higher classes.

The framework in MDR Articles 87 to 92 and IVDR Articles 77 to 82 requiring manufacturers to report serious incidents, deaths and field safety corrective actions to competent authorities within defined timelines.

An event that led, could have led or may lead to death or serious deterioration in health, or a serious public health threat, that is directly or indirectly associated with a device, triggering reporting obligations.

A corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident, such as device recall, modification, software update or revised instructions for use, and which must be reported.

The communication sent by a manufacturer to users and customers to inform them of a field safety corrective action, describing the risk, the action required and the contact point, coordinated with the competent authority.

The proactive collection and evaluation of clinical data from the use of a device after CE marking, intended to confirm safety and performance, detect emerging risks and update the clinical evaluation, documented in a PMCF plan and report.

A system under MDR Article 27 and Annex VI assigning a device identifier and production identifier to each device and its packaging, recorded in EUDAMED and on labels to enable traceability and post-market identification.

The primary identifier of a device model or family sharing intended purpose, risk class and essential design characteristics, used as the key linking entry in EUDAMED and in certificates and declarations of conformity.

The machine-readable representation of the UDI placed on the label or device, using AIDC technology such as a linear barcode, Data Matrix or RFID, with human-readable interpretation required for certain use environments.

The European database on medical devices established under MDR Article 33, comprising modules for actors, UDI and devices, certificates, clinical investigations, vigilance and market surveillance, used to register devices and economic operators.

A manufacturer, authorised representative, importer or distributor as defined in MDR Article 2, each carrying specific registration, verification and traceability obligations within the supply chain.

A unique identifier issued to an economic operator or device once its EUDAMED actor registration is validated by a competent authority, used in certificates, declarations and communications.

The competent authority activity under MDR Articles 93 to 98 of monitoring devices on the market, reviewing documentation and post-market data, and taking measures for non-compliant or unsafe devices.

The individual within a manufacturer or authorised representative who fulfils MDR Article 15 duties, including checking conformity before release, maintaining technical documentation and post-market obligations, and managing vigilance reporting.

The package of information a manufacturer assembles before entering a device in a register or database, typically including device identification, classification rationale, conformity route and economic operator details, ready for authority review.