Scientific validity

Used in the MDR in relation to how clinical data is planned, evaluated and concluded upon, without being defined there. Guidance treats it as covering adequacy of study design, control of bias, relevance of the research question, and the soundness of the methodology used to reach conclusions. Distinct from the IVDR term scientific validity of an analyte, which is defined and means something narrower.

Reference: MDCG 2020-6

Serious public health threat

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.

Reference: MDR Article 2(66); IVDR Article 2(69)

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. Under the IVDR: 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, 02017R0746 — EN — 10.01.2025 — 005.001 — 10 (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.

Reference: MDR Article 2(58); IVDR Article 2(61)

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)

Shipping container

A container in relation to which traceability is controlled by a process specific to logistics systems.

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

Similar device

A device in the same generic device group as the subject device. Similarity supports contextual understanding, such as state of the art or safety and performance objectives, but it is not equivalence and does not permit another device’s clinical data to be used as if it were the subject device’s.

Reference: MDCG 2020-6

Single-use device

A device that is intended to be used on one individual during a single procedure. Under the IVDR: a device that is intended to be used during a single procedure; 02017R0746 — EN — 10.01.2025 — 005.001 — 5.

Reference: MDR Article 2(8); IVDR Article 2(9)

SOTA — State of the art

The developed stage of current technical capability and accepted clinical practice for a product, process or approach to patient management, based on consolidated findings of science, technology and experience. It is what is generally accepted as good practice now, not necessarily the most advanced technology available.

Reference: MDCG 2020-6; IMDRF GRRP WG N47

Sponsor

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. Under the IVDR: 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.

Reference: MDR Article 2(49); IVDR Article 2(57)

SRN — Single registration number

The identifier issued by a competent authority to a manufacturer, authorised representative or importer once its registration data has been verified. It is used when applying to a notified body and when accessing Eudamed.

Reference: MDR Article 31(2); IVDR Article 28(2)

SSCP — Summary of safety and clinical performance

A public-facing summary required for implantable and class III devices, other than custom-made or investigational devices. It is written for the intended user and, where relevant, the patient, is validated by the notified body during conformity assessment, and is published in Eudamed. The equivalent under the IVDR is the summary of safety and performance.

Reference: MDR Article 32

Subject

An individual who participates in a clinical investigation. Under the IVDR: 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.

Reference: MDR Article 2(50); IVDR Article 2(47)

System

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

Reference: MDR Article 2(11)

TD — Technical documentation

The manufacturer’s evidence file showing that a device meets the applicable requirements. Its contents are prescribed rather than optional: device description, design and manufacturing information, evidence against the general safety and performance requirements, risk management, verification and validation, and post-market surveillance documentation.

Reference: MDR Article 10(4) and Annexes II and III; IVDR Article 10(4) and Annexes II and III

Trend reporting

The obligation to report any statistically significant increase in the frequency or severity of incidents that are not themselves serious, or of expected undesirable side-effects, where that increase could materially affect the benefit-risk determination.

Reference: MDR Article 88; IVDR Article 83

UDI — Unique Device Identifier

A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.

Reference: MDR Article 2(15); IVDR Article 2(15)

UDI carrier

The means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID. 2. General requirements 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation. 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used. 3. The UDI 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements. 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. 3.4. The UDI-DI shall be unique at each level of device packaging. 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI. 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI. 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard. 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI: (a) name or trade name, (b) device version or model, (c) labelled as single use, (d) packaged sterile, (e) need for sterilization before use, (f) quantity of devices provided in a package, (g) critical warnings or contra-indications: e.g. containing latex or DEHP. 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI. 4. UDI carrier 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers. 4.2. In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level. 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.

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

UDI-DI — UDI device identifier

A unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.

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

UDI-PI — UDI production identifier

A numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

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

Unit of Use DI — Unit of Use device identifier

Serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.

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