Performance

The ability of a device to achieve its intended purpose as stated by the manufacturer.

Reference: MDR Article 2(22)

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)

PMCF — Post-market clinical follow-up

The continuous process of proactively collecting and evaluating clinical data from a device already on the market, in order to confirm safety and performance across its expected lifetime, identify previously unknown side effects, and check that the benefit-risk position still holds. It is a planned activity, not a reaction to complaints.

Reference: MDR Annex XIV Part B

PMCF plan — Post-market clinical follow-up plan

The document specifying the methods, rationale and time schedule for PMCF activities, including the general and specific methods to be used, references to the relevant parts of the clinical evaluation report, and the objectives the activities are meant to address.

Reference: MDR Annex XIV Part B point 6

PMCF evaluation report — Post-market clinical follow-up evaluation report

The manufacturer’s analysis of the findings of PMCF activities. It forms part of both the clinical evaluation report and the technical documentation, and its conclusions feed back into the clinical evaluation and the benefit-risk determination.

Reference: MDR Annex XIV Part B point 7

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

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)

Procedure pack

A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Reference: MDR Article 2(10)

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)

Reprocessing of single-use devices

The process applied to a used device to allow safe reuse, permitted only where national law allows it and only in accordance with the regulation and the relevant common specifications. Anyone reprocessing a single-use device is treated as the manufacturer of the reprocessed device.

Reference: MDR Article 17

Reprocessing

A process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.

Reference: MDR Article 2(39)

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 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

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)

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