Home › Legislation
UK UK IVD (designated)
UK designated — 57 entries. Source: ds-medical-devices-ivd-list-v02.ods. Snapshot: 2026-08-16.
| Annex | Reference | Title | Withdrawal |
|---|---|---|---|
| S.I. 2002/618 | EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medica | 17/01/2026 |
| S.I. 2002/618 | EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medica | |
| S.I. 2002/618 | EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medica | 17/01/2026 |
| S.I. 2002/618 | EN 556-2:2024 | Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 2: Requirements for aseptically processed medica | |
| S.I. 2002/618 | EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process fo | 30/09/2021 |
| S.I. 2002/618 | EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process fo | |
| S.I. 2002/618 | EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | |
| S.I. 2002/618 | EN ISO 11137-2:2015 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose | |
| S.I. 2002/618 | EN ISO 11737-2:2009 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a s | 17/01/2026 |
| S.I. 2002/618 | EN ISO 11737-2:2020 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance o | |
| S.I. 2002/618 | EN 12322:1999 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media | |
| S.I. 2002/618 | EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) | 17/01/2026 |
| S.I. 2002/618 | EN ISO 13408-1:2024 | Aseptic processing of health care products - Part 1: General requirements | |
| S.I. 2002/618 | EN ISO 13408-2:2011 | Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) | 30/09/2021 |
| S.I. 2002/618 | EN ISO 13408-2:2018 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) | |
| S.I. 2002/618 | EN ISO 13408-3:2011 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) | |
| S.I. 2002/618 | EN ISO 13408-4:2011 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) | |
| S.I. 2002/618 | EN ISO 13408-5:2011 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) | |
| S.I. 2002/618 | EN ISO 13408-6:2011 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) | 17/01/2026 |
| S.I. 2002/618 | EN ISO 13408-6:2021 | Aseptic processing of health care products - Part 6: Isolator systems | |
| S.I. 2002/618 | EN ISO 13408-7:2015 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) | |
| S.I. 2002/618 | EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 30/09/2021 |
| S.I. 2002/618 | EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 17/01/2026 |
| S.I. 2002/618 | EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes | |
| S.I. 2002/618 | EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing | |
| S.I. 2002/618 | EN 13612:2002 | Performance evaluation of in vitro diagnostic medical devices | |
| S.I. 2002/618 | EN 13641:2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents | |
| S.I. 2002/618 | EN 13975:2003 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects | |
| S.I. 2002/618 | EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures | |
| S.I. 2002/618 | EN 14254:2004 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans | |
| S.I. 2002/618 | EN 14820:2004 | Single-use containers for human venous blood specimen collection | |
| S.I. 2002/618 | EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine c | |
| S.I. 2002/618 | EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | |
| S.I. 2002/618 | EN ISO 14971:2019 | Medical devices – Application of risk management to medical devices | |
| S.I. 2002/618 | EN ISO 15193:2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of referen | |
| S.I. 2002/618 | EN ISO 15194:2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and t | |
| S.I. 2002/618 | EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) | |
| S.I. 2002/618 | EN ISO 15223-1:2016 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1: | 17/01/2026 |
| S.I. 2002/618 | EN ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | |
| S.I. 2002/618 | EN ISO 17511:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators an | 17/01/2026 |
| S.I. 2002/618 | EN ISO 17511:2021 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control mate | |
| S.I. 2002/618 | EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO | |
| S.I. 2002/618 | EN ISO 18113-2:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use | |
| S.I. 2002/618 | EN ISO 18113-3:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional | |
| S.I. 2002/618 | EN ISO 18113-4:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (IS | |
| S.I. 2002/618 | EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing | |
| S.I. 2002/618 | EN ISO 18153:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentratio | |
| S.I. 2002/618 | EN ISO 20776-1:2006 | Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimi | |
| S.I. 2002/618 | EN ISO 20916:2024 | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice | |
| S.I. 2002/618 | EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) | |
| S.I. 2002/618 | EN ISO 25424:2019 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a ste | |
| S.I. 2002/618 | EN ISO 25424:2019 | Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a ste | |
| S.I. 2002/618 | EN 61010-2-101:2002 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnosti | |
| S.I. 2002/618 | EN 61326-2-6:2006 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) me | |
| S.I. 2002/618 | EN 62304:2006 | Medical device software - Software life-cycle processes (IEC 62304:2006) | |
| S.I. 2002/618 | EN 62366:2008 | Medical devices - Application of usability engineering to medical devices | 17/01/2026 |
| S.I. 2002/618 | EN 62366‑1:2015 | Medical devices - Application of usability engineering to medical devices |