--- title: UK increases approved body capacity for IVDs description: MHRA confirms that UL International UK Limited's designation as a UK approved body for medical devices has been expanded to include the majority of IVDs image: https://www.regtik.com/hubfs/testalize-me-0jE8ynV4mis-unsplash%202.jpg --- [Skip to content](https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds#main-content) [![LOGO with text Syntacog](https://www.regtik.com/hs-fs/hubfs/LOGO%20with%20text%20Syntacog.png?width=200&height=141&name=LOGO%20with%20text%20Syntacog.png)](https://www.regtik.com) - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) Open main navigation Close main navigation - [Medical Devices](https://www.regtik.com/medical-devices) - [Blog](https://www.regtik.com/mdrblog) - [Newsletter](https://www.regtik.com/news) - [Contact Us](https://www.regtik.com/contact-us) - [Sign Up](https://app.regtik.com/users/log_in) [Sign Up](https://app.regtik.com/users/log_in) [Medical Device](https://www.regtik.com/mdrblog/tag/medical-device) [UK](https://www.regtik.com/mdrblog/tag/uk) [MHRA](https://www.regtik.com/mdrblog/tag/mhra) # UK increases approved body capacity for IVDs Published by [Isabella Greenock, Medical Device Paralegal](https://www.regtik.com/mdrblog/author/isabella-greenock-medical-device-paralegal) on Feb 14, 2023 2:34:50 PM ![](https://www.regtik.com/hs-fs/hubfs/testalize-me-0jE8ynV4mis-unsplash%202.jpg?width=1024&height=450&name=testalize-me-0jE8ynV4mis-unsplash%202.jpg) The MHRA has extended the scope of UL International UK Limited’s approved body designation to include almost all types of in vitro diagnostic medical devices. Previously UL had only been designated to assess a single category of IVD devices - those for evaluating the risk of trisomy 21. However, the organisation’s scope has now been widened to cover the majority of IVDs. The only categories of IVD devices which UL is *not* designated to assess are: - Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation - Reagents and reagent products for diagnosing the hereditary disease phenylketonuria - Reagents and reagent products for determining the HLA tissue groups DR, A and B - Haematology self-testing devices.1 By extending UL’s scope, the MHRA has taken further steps towards increasing the UK’s approved body capacity. This has been a priority post-Brexit since the UK is no longer able to rely on the EU’s wider network of notified bodies. As a result, the UK is currently experiencing an approved body bottleneck, with manufacturers facing lengthy delays in the certification process. Approved bodies play a vital role in assessing the conformity of medical devices against the requirements of the UK Medical Device Regulations 2002. Undergoing an approved body evaluation is a requirement for all IVDs listed in Annex II of the [IVD Directive](https://www.legislation.gov.uk/eudr/1998/79/contents), as well as all IVD devices for self testing.  If you need help figuring out the legal requirements for your medical device, please consider registering your interest in Regtik - our healthcare regulatory explorer tool.   \[1\]  Currently BSI Assurance UK Ltd. and SGS United Kingdom are the only UK approved bodies whose scope covers these types of devices (although SGS is not designated to assess vCJD assays) ###### Related News Articles [![](https://www.regtik.com/hs-fs/hubfs/Risk%20Ahead%20blue%20road%20sign.jpeg?width=624&height=427&name=Risk%20Ahead%20blue%20road%20sign.jpeg)](https://www.regtik.com/mdrblog/june-2023-target-date-for-new-uk-medical-devices-regulations-looking-ever-more-unrealistic-warns-head-of-abhi) [Medical Device](https://www.regtik.com/mdrblog/tag/medical-device), [MDR](https://www.regtik.com/mdrblog/tag/mdr), [UK](https://www.regtik.com/mdrblog/tag/uk), [MHRA](https://www.regtik.com/mdrblog/tag/mhra) #### [ABHI: June target for new UK MDR looking "ever more unrealistic"](https://www.regtik.com/mdrblog/june-2023-target-date-for-new-uk-medical-devices-regulations-looking-ever-more-unrealistic-warns-head-of-abhi) Peter Ellingworth – Chief Executive of the [Association of British HealthTech Industries](https://www.abhi.org.uk/) (ABHI)... [![](https://www.regtik.com/hs-fs/hubfs/Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg?width=624&height=427&name=Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg)](https://www.regtik.com/mdrblog/dekra-joins-approved-body-list) [Medical Device](https://www.regtik.com/mdrblog/tag/medical-device), [UK](https://www.regtik.com/mdrblog/tag/uk) #### [DEKRA joins UK Approved Body list](https://www.regtik.com/mdrblog/dekra-joins-approved-body-list) The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed the appointment... [![](https://www.regtik.com/hs-fs/hubfs/Businessman%20on%20ladder%20pointing%20at%20sandglass%20picture%20on%20wall.jpeg?width=624&height=427&name=Businessman%20on%20ladder%20pointing%20at%20sandglass%20picture%20on%20wall.jpeg)](https://www.regtik.com/mdrblog/mhra-new-uk-mdr-now-postponed-to-july-2024) [Medical Device](https://www.regtik.com/mdrblog/tag/medical-device), [MDR](https://www.regtik.com/mdrblog/tag/mdr), [UK](https://www.regtik.com/mdrblog/tag/uk), [MHRA](https://www.regtik.com/mdrblog/tag/mhra) #### [MHRA: New UK MDR now postponed to July 2024](https://www.regtik.com/mdrblog/mhra-new-uk-mdr-now-postponed-to-july-2024) The Medicines and Healthcare products Regulatory Agency (MHRA) - the national regulator for medical... [![](https://www.regtik.com/hs-fs/hubfs/a%20dna%20in%20medical%20colour%20background.jpeg?width=624&height=427&name=a%20dna%20in%20medical%20colour%20background.jpeg)](https://www.regtik.com/mdrblog/changes-to-the-classification-rules-for-ivds-in-the-uk-expected-in-2023) [Medical Device](https://www.regtik.com/mdrblog/tag/medical-device), [UK](https://www.regtik.com/mdrblog/tag/uk), [IVD](https://www.regtik.com/mdrblog/tag/ivd), [EU](https://www.regtik.com/mdrblog/tag/eu), [IMDRF](https://www.regtik.com/mdrblog/tag/imdrf) #### [UK to align with IMDRF on IVD classification](https://www.regtik.com/mdrblog/changes-to-the-classification-rules-for-ivds-in-the-uk-expected-in-2023) On June 26 2022, the UK government published its response to the Medicines and Healthcare products... [![LOGO white](https://www.regtik.com/hs-fs/hubfs/LOGO%20white.png?width=200&height=141&name=LOGO%20white.png "LOGO white")](https://www.syntacog.com) Making regulatory compliance simple #### Services - Medical Device Qualification - Medical Device Classification - Regulatory Pathways - Regulatory Strategy - Consulting #### Contact - +44 (0) 203 026 5881 - info@syntacog.com - [7 Bell Yard, London WC2A 2JR, England, United Kingdom](https://goo.gl/maps/sdTcKjFxWk1ySx1UA) - [LinkedIn](https://www.linkedin.com/company/syntacog-ltd) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Isabella Greenock, Medical Device Paralegal", "url" : "https://www.regtik.com/mdrblog/author/isabella-greenock-medical-device-paralegal" }, "dateModified" : "2023-02-14T14:34:50.089Z", "datePublished" : "2023-02-14T14:34:50.000Z", "headline" : "UK increases approved body capacity for IVDs", "image" : [ "https://www.regtik.com/hubfs/testalize-me-0jE8ynV4mis-unsplash%202.jpg" ], "mainEntityOfPage" : { "@id" : "https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://www.regtik.com/hubfs/LOGO%20with%20text%20Syntacog-1.png" } } } ```