Approved Body:

A conformity assessment body appointed by a UK Competent Authority to undertake conformity assessment activities for the purposes of UKCA marking of products to be placed on the GB market. Note: The term Approved Body is used generically in this document and should be read to include other categories of appointment such as Designated Body, Technical Assessment Body (TAB) and Recognised Third-Party Organisation (RTPO).

UK Notified Body:

A conformity assessment body appointed by the UK Government to undertake conformity assessment activities for the purpose of Notified Body activity in Northern Ireland. Note: The term UK Notified Body is used generically in this document and should be read to include other categories of appointment such as Designated Body, Technical Assessment Body (TAB) and Recognised Third-Party Organisation (RTPO).

Clinical Data:

The safety and/or performance information that is generated from the use of a device. Clinical data are sourced from: — clinical investigation(s) of the device concerned; or — clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or — published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Clinical Evaluation:

The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.

Clinical Evidence:

The clinical data and the clinical evaluation report pertaining to a medical device. Clinical Investigation: Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device. Clinical Investigation Plan: Document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation.

Clinical Performance:

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

Clinical Safety:

The absence of unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.

Conformity Assessment:

The systematic examination of evidence generated, and procedures undertaken by the manufacturer, according to Article 9 of directive 90/385/EEC and Article 11 of directive 93/42/EEC, to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Requirements according to Annex 1 of directive 90/385/EEC and Annex I of directive 93/42/EEC.

Device intended for Clinical Investigation:

Any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Sections 2.1 of Annex 7 of directive 90/385/EEC and section 2.1 of Annex X of directive 93/42/EEC in an adequate human clinical environment.

Designated standards:

Standards designated by the UK government that can confer a presumption of conformity with relevant UK regulations, including the ISO/IEC 17000 series of standards used for the purposes of accreditation. Note: These replace the harmonised standards published by the European Commission in the Official Journal of the EU.

Medical device:

Any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis, prevention, monitoring, treatment or alleviation of disease.

Quality Management System (QMS):

A system intended to ensure that the manufacturer has the appropriate infrastructure and procedures in place to consistently manufacture medical devices which meet the requirements of the Medical Devices Regulations 2002 (as amended) (UK medical devices regulations).