--- title: DEKRA joins UK Approved Body list description: Blog post on the appointment of Dekra Certification UK as an Approved Body for medical devices in Great Britain image: https://www.regtik.com/hubfs/Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg --- [Skip to content](https://www.regtik.com/mdrblog/dekra-joins-approved-body-list#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) # DEKRA joins UK Approved Body list Published by [Isabella Greenock, Medical Device Paralegal](https://www.regtik.com/mdrblog/author/isabella-greenock-medical-device-paralegal) on Oct 10, 2022 8:00:00 AM ![](https://www.regtik.com/hs-fs/hubfs/Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg?width=1024&height=450&name=Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg) The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed the appointment of DEKRA Certification UK as an Approved Body for medical devices - making it the first organisation to obtain this designation since the new system was introduced after the UK’s withdrawal from the EU. Approved Bodies play a vital role in assessing the conformity of medical devices against the requirements of the UK Medical Device Regulations 2002. With the exception of low-risk Class I devices, all manufacturers must obtain certification from an Approved Body before placing their products on the market in Great Britain. DEKRA now joins three existing Approved Bodies - BSI Assurance UK, SGS United Kingdom and UL International - in being able to carry out this assessment. The type of devices that each of these organisations are able to assess varies. DEKRA is only permitted to issue certification for general medical devices (not in vitro diagnostic devices or active implantable devices). Its scope is also limited to applications for devices to be placed on the market in Great Britain (not Northern Ireland). The MHRA hopes that DEKRA’s appointment will substantially increase “the UK’s capacity to process conformity assessments for medical devices”.\[1\] This is an important priority post-Brexit as the UK is no longer able to rely on the EU’s larger network of Notified Bodies. That said, although the UK is currently experiencing an Approved Body bottleneck, the EU is also facing a similar challenge following the introduction of the EU Medical Device Regulations and In Vitro Device Regulations. Due to the more stringent requirements and limited conformity assessment capacity, medical device manufacturers in the EU have reported lengthy delays in the certification process.\[2\] The appointment of DEKRA is a welcome step towards addressing this issue for manufacturers in the UK. However, there is undoubtedly still room for more work to be done in increasing the UK’s capacity, especially as Brexit transition periods draw to a close and the number of manufacturers who will be required to obtain UK certification increases.  We are also keeping an eye out for future Approved Body appointments - the MHRA has stated that there are currently six organisations progressing through the assessment process and it is actively engaging with others preparing their initial submissions. Subscribe to our [newsletter](https://www.regtik.com/medical-device-newsletter-signup) to keep up to date on the most recent developments.   \[1\] MHRA Press Release, [MHRA appoints first new UK Approved Body to certify medical devices since Brexit, 29 September 2022](https://www.gov.uk/government/news/mhra-appoints-first-new-uk-approved-body-to-certify-medical-devices-since-brexit) \[2\] Team NB, [Notified Body position paper on MDR/IVDR Implementation, 1 December 2021](https://www.team-nb.org/wp-content/uploads/2021/12/Team-NB-PositionPaper-on-MDR_IVDR-Implementation-V3.pdf) ###### Related News Articles [![](https://www.regtik.com/hs-fs/hubfs/testalize-me-0jE8ynV4mis-unsplash%202.jpg?width=624&height=427&name=testalize-me-0jE8ynV4mis-unsplash%202.jpg)](https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds) [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](https://www.regtik.com/mdrblog/uk-increases-approved-body-capacity-for-ivds) The MHRA has extended the scope of UL International UK Limited’s approved body designation to... [![](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/Earth%20planet%20on%20grey%20background%20with%20pencil%20sketches.%20Elements%20of%20this%20image%20are%20furnished%20by%20NASA.jpeg?width=624&height=427&name=Earth%20planet%20on%20grey%20background%20with%20pencil%20sketches.%20Elements%20of%20this%20image%20are%20furnished%20by%20NASA.jpeg)](https://www.regtik.com/mdrblog/new-uk-proposals-on-international-recognition-expected-in-february) [UK](https://www.regtik.com/mdrblog/tag/uk), [Mutual Recognition Agreements](https://www.regtik.com/mdrblog/tag/mutual-recognition-agreements) #### [New UK proposals on international recognition expected in February](https://www.regtik.com/mdrblog/new-uk-proposals-on-international-recognition-expected-in-february) The UK Life Sciences Council has issued a [statement](https://www.gov.uk/government/news/life-sciences-council-joint-statement-on-medical-devices-regulatory-reform) concerning their agreement to publish proposals... [![](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... [![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" : "2022-10-10T07:00:00.909Z", "datePublished" : "2022-10-10T07:00:00.000Z", "headline" : "DEKRA joins UK Approved Body list", "image" : [ "https://www.regtik.com/hubfs/Flag%20of%20United%20Kingdom%20-%20Button%20on%20Black%20Computer%20Keyboard..jpeg" ], "mainEntityOfPage" : { "@id" : "https://www.regtik.com/mdrblog/dekra-joins-approved-body-list", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://www.regtik.com/hubfs/LOGO%20with%20text%20Syntacog-1.png" } } } ```