Our glossary for guidance - Letter S

Shortcut for Serious Adverse Event

Any adverse event that led to any of the following:
a) death,
b) serious deterioration in the health of the subject, that resulted in any of the following:

• i. life-threatening illness or injury,
• ii. permanent impairment of a body structure or a body function,
• iii. hospitalisation or prolongation of patient hospitalisation,
• iv. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body
• function,
• v. chronic disease,

c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect

[Definition of the term according to MDCG 2020-10/1, entspricht auch Begriffsdefinition gemäß (EU) 2017/745 Artikel 2 Nr. 58]

One or more units of product, either components or finished devices, drawn from a batch without regard to the quality of the units [refer to EN 13975:2003]

[Definition according to MDCG 2022-3 No. 3.6]

‘Scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state.

[Definition according to (EU) 2017/746 Article 2 No. 38]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 38]

This terminology is used in the MDR in reference to clinical data planning, evaluation and conclusions12. Clinical evaluations must follow a “defined and methodologically sound procedure”13, for which expectations of scientific validity are implicit. Embedded in the term ‘scientific validity’ are concepts including adequacy of study design and controls for bias, appropriateness and relevance of research questions, adequacy of sample sizes and statistical analyses, completeness of data, adequacy of follow up period, and appropriateness of conclusions on the basis of objective evidence. Section 9.3.1 of MEDDEV 2.7/1 rev. 4 provides guidance for the evaluation of methodological quality and scientific validity under the MDD/AIMDD which are equally valid under the MDR which can be considered to apply when referencing ‘Scientific validity’ in this guidance.

[Definition according to MDCG 2020-6 No. 1.2]

Supply Chain Management

Overcoming the inner pig.

device intended by the manufacturer to be used by lay persons in a home environment.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

Mentor/ Guardian.

‘Serious adverse event’ means any adverse event that led to any of the following:

(a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,

(b) death,

(c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:

• (i) life-threatening illness or injury,
• (ii) permanent impairment of a body structure or a body function,
• (iii) hospitalisation or prolongation of patient hospitalisation,
• (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
• (v) chronic disease,

(d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

[Definition according to (EU) 2017/746 Article 2 No. 61]

‘Serious adverse event’ means any adverse event that led to any of the following:

(a) death,

(b) serious deterioration in the health of the subject, that resulted in any of the following:

• (i) life-threatening illness or injury,
• (ii) permanent impairment of a body structure or a body function,
• (iii) hospitalisation or prolongation of patient hospitalisation,
• (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
• (v) chronic disease,

(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

[Definition according to (EU) 2017/745 Article 2 No. 58]

‘Serious incident’ means 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.

[Definition under (EU) 2017/745 Article 2 No. 65 also corresponds to definition under (EU) 2017/746 Article 2 No. 68]

‘Serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

[Definition under (EU) 2017/745 Article 2 No. 66 also corresponds to definition under (EU) 2017/746 Article 2 No. 69]

Dorian Shainin - an American statistician - developed quality control charts, Lot Plot method and the "Red X" concept.

Four practitioner methods to narrow down and identify influencing variables:

• Multi-variation maps
• Component exchange
• pairwise comparison
• Process comparison and variable search

Shopfloor, derived from factory, refers to the place of productivity / value creation. Shop floor management refers to the down-to-earth management on site, at the place of value creation.

Area of responsibility:

• Detection of deviations from the defined target state
• Sustainable elimination of problems (building up problem-solving competencies among employees)
• Order control
• Leading employees with the help of visualised KPIs

Normally intended for continuous use for between 60 minutes and 30 days.

[Definition of term as defined in MDCG 2021-24 No. 3.1.2]

Normally intended for continuous use for not more than 30 days.

[Definition according to (93/42/EEC) Annex IX No. 1.1]

‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 1.2]

The concept of significant change for energy includes changes in the nature, level and density of energy (see Rule 9). This means that for instance an electrode is not considered an active device under this classification system as long as the energy input is intended to be the same as the energy output. Resistance in a wire that causes minor changes between input and output cannot be considered to constitute ‘significant change’. However, electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

devices belonging to the same generic device group. The MDR defines this as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

[Definition according to MDCG 2020-6 No. 1.2]

‘Single-use device’ means a device that is intended to be used on one individual during a single procedure.

‘Single-use device’ means a device that is intended to be used during a single procedure.

[Definition under (EU) 2017/745 Article 2 No. 8 also corresponds to definition under (EU) 2017/746 Article 2 No. 9]

SPIOC or LIPOK diagrams are acronyms and stand for:

• Supplier
• Input
• Process
• Output
• Customer

Statistical process optimisation or method for quality management that describes the freedom from errors of processes with 99.99966% certainty and thus reduces the audit effort through robust processes.

SMART is used to define goals and is an acronym for:

• Specific
• Measurable
• Achievable
• Relevant
• Timely

Single Minute Exchange of Die - Set-up in the single-digit minute range.

Social competence.

A software FMEA (SW-FMEA for short) examines the risks related to the programme code to be generated.

Software is also an active device. Software should be reviewed not only in the context of Rule 11.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

SOS is an acronym, stands for "Safety, Order and Cleanliness" and refers to such a focused tour.

SPA is an English acronym and stands for "Second Party Audit".

Path diagram for visualising paths and distances travelled during a process.

Statistical Process Control - a visual representation of statistical processes developed by Walter A. Shewhart.

‘Specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

[Definition according to (EU) 2017/746 Article 2 No. 3].

Is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

[Definition according to MDCG 2022-2 No. 4]

Small portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole.

[Definition according to MDCG 2022-3 No. 3.7]

‘Sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study.

[Definition according to (EU) 2017/746 Article 2 No. 57]

‘Sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation.

[Definition according to (EU) 2017/745 Article 2 No. 49]

Explosives Storage Guidelines.

Shortcut for Single Registration Number

Shortcut for Single Registration Number.

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

A SRN is the Single Registration Number that is issued through EUDAMED to manufacturers, authorised representatives and importers by the competent authority in accordance with Article 31 MDR and 28 IVDR.

[Definition according to MDCG 2021-13 rev.1 Terminology]

Shortcut for Summary of Safety and Clinical Performance.

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

Internal analysis of the balance of power and its impact on the project, which should be done by the project leader, for himself.

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

A standard corresponds to a recognised and established standard with a scope and agreement on firmly defined processes. For standards, there are different areas of validity in which this standard can be valid, e.g. DIN standards, which are valid throughout Germany.

IMDRF/GRRP WG/N47 provides the following definition: Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant
consolidated findings of science, technology and experience. Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the “generally acknowledged state-ofthe-art“.

[Definition according to MDCG 2020-6 No. 1.2]

Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience.
Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the “generally acknowledged state-of-the-art” Source: Modified from IMDRF/GRRP WG/N47 FINAL:2018

[Definition according to MDCG 2022-2 No. 4]

State of affairs.

The term sterilisation is used to describe processes that free materials from living microorganisms as well as their resting stages through various influences - such as physical or chemical. This state is generally referred to as sterile.

Strategic indicators control effectiveness, e.g. profit, sales growth, profitability,...

‘Subject’ means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes.

[Definition according to (EU) 2017/746 Article 2 No. 47]

‘Subject’ means an individual who participates in a clinical investigation;

[Definition under (EU) 2017/745 Article 2 No. 50]

Substitution, i.e. the replacement of e.g. a substance, is carried out according to the STOP(V) rule, whereby the prioritisation is now shown as decreasing:

1. Substitution / replacement
2. technical solution
3. organisational solution
4. personal solution
5. behavioural solution

Article 29 specifies the information, including data on performance evaluation and respective conclusions, which manufacturers have to provide to notified bodies for validation and to make available to the public in the “Summary of safety and performance” in the EUDAMED database.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 29]

The supermarket principle is the regular replenishment of stock and shelf space with their allocated items, managed via min and max stocks.

2nd-party audit; usually carried out by a client's management representative or similarly trained person at their supplier's premises.

This is a cross-organisational, systematic value creation system with suppliers in a network-like structure in which processes are interlinked and exchanged via flows of goods, finance and information.

Support processes include all supporting processes (e.g. waste management, complaints management, technology, maintenance and repair, purchasing, etc.).

An invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and a device which produces penetration other than through a body orifice.
The term surgical operation used in this definition includes all clinical interventional procedures in which a device is placed into the body through the surface of the body. A surgically invasive device always implies that it enters through an artificially created opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening made by a needle. Therefore surgical gloves and needles used with syringes are surgically invasive.
In this context the following should be noted:

• a surgically created stoma used in urostomy, colostomy and ileostomy or permanent tracheostomy is considered to be a body orifice; therefore devices introduced into such a stoma are not surgically invasive.
• in contrast, a surgically created opening to allow access to the circulatory system should not be considered to be a body orifice. Devices introduced into such an opening are surgically invasive.

The concept of surgically invasive should be understood to cover also liquids that are in invasive contact with organs, tissues or other parts of the body if the access for such liquids is through a surgically created opening.
For a device that administers a substance, such a substance must be assessed in its own right (e.g. substances administered by a jet injector).

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

‘Surgically invasive device’ means:

(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and

(b) a device which produces penetration other than through a body orifice.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.2]

The SWOT analysis (acronym for Strengths, Weaknesses, Opportunities and Threats) is a business analysis method.

The internal analysis refers to the two points "strengths" and "weaknesses", the external analysis to "opportunities" and "threats". After these points have been worked out, these findings are transformed into strategies in which the following points are combined:

• SO strategy (strengths & opportunities)
• ST strategy (strengths & threats)
• WO strategy (weaknesses & opportunities)
• WT strategy (weaknesses & risks)

A system audit deals with conformity, related to the designated management system.

A system FMEA (S-FMEA) examines the influences and potential failure opportunities in the interaction of subsystems in a system network. However, special attention is paid to the interfaces of the individual components and the effects of their interaction.

A system means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

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

‘System’ means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.

[Definition according to (EU) 2017/745 Article 2 No. 11]

The process by which substances or their metabolites enter the body (e.g. by crossing mucous membranes) and are distributed into the body via the blood and/or lymphatic system.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]