Placing on the market

The first making available of a device, other than an investigational device, on the Union market. Under the IVDR: the first making available of a device, other than a device for performance study, on the Union market.

Reference: MDR Article 2(28); IVDR Article 2(21)

PMPF — Post-market performance follow-up

The IVDR counterpart to PMCF: a continuous process of updating the performance evaluation using data gathered from the device in routine use, addressed in a PMPF plan and reported in a PMPF evaluation report that forms part of the performance evaluation report.

Reference: IVDR Annex XIII Part B

PMS plan — Post-market surveillance plan

The plan describing how the manufacturer will collect and analyse experience from devices on the market, what indicators and thresholds will be used, and how complaints, trends and field data feed into corrective action. It forms part of the technical documentation.

Reference: MDR Article 84 and Annex III; IVDR Article 79 and Annex III

PMS report — Post-market surveillance report

The lighter-touch reporting route for lower-risk devices, summarising the results and conclusions of post-market surveillance together with any preventive and corrective actions taken. It is updated as necessary and made available to authorities on request rather than routinely submitted.

Reference: MDR Article 85; IVDR Article 80

Positive predictive value

The ability of a device to separate true positive results from false positive results for a given attribute in a given population.

Reference: IVDR Article 2(52)

Post-market surveillance

All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

Reference: MDR Article 2(60); IVDR Article 2(63)

Predictive value

The probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition.

Reference: IVDR Article 2(51)

PRRC — Person responsible for regulatory compliance

The individual a manufacturer must have available with defined qualifications or experience, responsible for release checks, technical documentation and the declaration of conformity, post-market surveillance obligations and vigilance reporting. Micro and small enterprises need not employ the person directly but must have one permanently at their disposal.

Reference: MDR Article 15; IVDR Article 15

PSUR — Periodic safety update report

The recurring post-market report required for higher-risk devices, summarising surveillance findings, the conclusions of the benefit-risk determination, the main findings of post-market follow-up, and sales volume with an estimate of the population using the device. Update frequency depends on risk class.

Reference: MDR Article 86; IVDR Article 81

Putting into service

The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose. Under the IVDR: the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.

Reference: MDR Article 2(29); IVDR Article 2(22)

QMS — Quality management system

The documented system through which a manufacturer ensures ongoing compliance, proportionate to risk class and device type. The regulation lists the aspects it must cover, including regulatory compliance strategy, risk management, clinical evaluation or performance evaluation, product realisation, post-market surveillance and vigilance.

Reference: MDR Article 10(9); IVDR Article 10(8)

Recall

Any measure aimed at achieving the return of a device that has already been made available to the end user.

Reference: MDR Article 2(62); IVDR Article 2(65)

RFID — Radio frequency identification

A technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Risk

The combination of the probability of occurrence of harm and the severity of that harm.

Reference: MDR Article 2(23); IVDR Article 2(16)

Risk management

The continuous iterative process, run across the whole device lifecycle, of identifying hazards, estimating and evaluating risks, controlling them and monitoring the effectiveness of those controls. It must be established, documented, implemented and maintained, and updated with production and post-market information.

Reference: MDR Article 10(2) and Annex I Section 3; IVDR Article 10(2) and Annex I Section 3

RUO — Research use only

A product not intended for in vitro diagnostic examination and therefore outside the IVDR, unless the manufacturer specifically intends it for diagnostic use in view of its characteristics. Labelling a product research use only does not exempt it if its intended purpose is diagnostic.

Reference: IVDR Article 1(3)(a)

SaMD — Software as a medical device

The international term for software intended for a medical purpose that performs that purpose without being part of a hardware medical device. Broadly parallel to medical device software in EU guidance, but the definitions are not interchangeable and the EU term should be used in EU submissions.

Reference: IMDRF SaMD WG N41

Scientific validity of an analyte

The association of an analyte with a clinical condition or a physiological state.

Reference: IVDR Article 2(38)

Scientific validity report

The report demonstrating the association between an analyte and the clinical condition or physiological state it is intended to identify. It is one of the three inputs the manufacturer assesses when establishing clinical evidence for an IVD.

Reference: IVDR Annex XIII Part A points 1.2.1 and 1.3.1

Serious incident

Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat. Under the IVDR: any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; 02017R0746 — EN — 10.01.2025 — 005.001 — 11.

Reference: MDR Article 2(65); IVDR Article 2(68)