Our glossary for guidance - Letter P

Bottleneck process that stops production altogether or sets the maximum flow.

Pareto analysis separates the "important" from the "less important" causes of problems. It thus presents the causes of problems in order of the importance of their effect.

The Pareto principle - also known as the "80-20 rule" - states that often problems can be solved with 20% to 80% of the resources, or that 80% of the resources must be used to solve the remaining 20%.

‘Particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries.

[Definition according to (EU) 2017/745 Article 2 No. 19]

PDCA stands for Plan, Do, Check, Act, formerly also PDSA (Plan, Do, Study, Action) and is number 5 of the 14 points of the management programme according to Deming. In Germany, PDCA stands for continuous planning, implementation, control and correction, or improvement of the management programme. More precisely, "P" stands for the planning of the improvement, "D" for the execution of the improvement measure, "C" for the review of the effectiveness and "A" for the implementation, standardisation or adaptation.

The PDCA scheme is carried out in four steps:

1. Problem analysis
2. Solution finding
3. Review
4. Implementation

A performance audit deals with the conformity related to the objective and systematic review of the set goals, their achievement (effectiveness) in relation to the resources used to achieve the goals - or whether these were used economically and efficiently.

‘Performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.

[Definition according to (EU) 2017/746 Article 2 No. 44].

An assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 44]

‘Performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

[Definition according to (EU) 2017/746 Article 2 No. 39].

Performance of a device means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 39]

‘Performance study plan’ means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

[Definition according to (EU) 2017/746 Article 2 No. 43].

A document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 43]

‘Performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device.

[Definition according to (EU) 2017/746 Article 2 No. 42].

A study undertaken to establish or confirm the analytical or clinical performance of a device.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 42]

‘Performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer.

[Definition according to (EU) 2017/745 Article 2 No. 22]

‘Placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished.

[Definition according to (98/79/EC) Article 1 No. 2i]

‘Placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market.

[Definition according to (EU) 2017/746 Article 2 No. 21]

'Placing on the market' means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished.

[Definition according to (93/42/EEC) Article 1 No. 2h]

‘Placing on the market’ means the first making available of a device, other than an investigational device, on the Union market.

[Definition according to (EU) 2017/745 Article 2 No. 28]

Private Label Manufacturer.

Shortcut for Post-Market Clinical Follow-up.

[Definition of terms according to MDCG 2021-6 Abbreviations, MDCG 2021-08 Acronyms, MDCG 2021-28 Acronyms, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Short cut for Post-Market-Surveillance

Shortcut for Post-Market-Surveillance

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Avoiding unintentional mistakes (Japanese) - System for preventive mistake avoidance.

So-called portfolio matrices, on which a large number of so-called tools are based, are structured as follows:

• 2-dimensional
• internal dimension on the abscissa
• external dimension on the ordinate - dividing lines (2; 4,...) to separate matrix segments

POSDCoRB is an acronym for:

• Planning
• Organizing
• Staffing
• Directoring
• Coordination
• Reporting
• Budgeting

‘Positive predictive value’ means the ability of a device to separate true positive results from false positive results for a given attribute in a given population.

[Definition according to (EU) 2017/746 Article 2 No. 52].

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 52]

‘Post-market surveillance’ means 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.

[Definition under (EU) 2017/745 Article 2 No. 60 also corresponds to definition under (EU) 2017/746 Article 2 No. 63]

acronym for parts per billion and represents the number 10^-9

acronym for parts per million and represents the number 10^-6.

acronym parts per trillion and represents the number 10^-12.

‘Predictive value’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 51].

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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 51]

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

[Definition of term as defined in MDCG 2021-24 No. 3.1.7]

‘Procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

[Definition according to (EU) 2017/745 Article 2 No. 10]

A process is a system of activities that turns inputs into outputs with the help of resources.

A process audit deals with conformity, related to a specific core process and the input and output processes aligned to it.

A process FMEA (P-FMEA for short), based on the design FMEA, investigates the influences and potential failure opportunities in the production or performance process.

The process map is a geographical division into management processes, core processes and support processes. It describes the structure of the company processes and the interaction of the sub-processes.

Process performance types are roughly divided into two categories: good processes and bad processes:

• Good processes are those that create and enable value.
• Bad processes are processes that perform blindly and processes that perform incorrectly. (Approach with CIP, possibly Six Sigma).

In the process view, a process is considered from beginning to end.

A product audit deals with conformity, related to a specific product/series and the input and output processes oriented to it. Mostly with a focus on the presumed customer expectations.

In 2007, the VDA combined the system FMEA and the HW/SW/design FMEA to form the so-called product FMEA, since the system under consideration cannot usually be resolved unambiguously.

In the product view, the entire path is considered, starting from the product, including the input and output processes.

A project audit deals with the status analysis (progress) of a project.

shortcut for Periodic Safety Update Report

Shortcut for Post-Market Surveillance Update Report.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Opposite of PUSH system - refers to production according to the customer's needs (customer cycle).

Opposite of pull system - refers to production according to planning.

'Putting into service' means making available to the medical profession for implantation.

[Definition according to (90/385/EEC) Article 1 No. 2g]

‘Putting into service’ means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose.

[Definition according to (98/79/EC) Article 1 No. 2j]

‘Putting into service’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 22]

'Putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.

[Definition according to (93/42/EEC) Article 1 No. 2i]

‘Putting into service’ means 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.

[Definition according to (EU) 2017/745 Article 2 No. 29]