IVD Regulations Within the UK: A Comprehensive Overview

Understanding the evolving landscape of UK IVD regulations as a manufacturer can be difficult when wanting to ensure the correct device regulatory requirements.

Navigating IVD devices within the UK market

Within this article, we provide a comprehensive overview of questions based on the prevailing controls governing the registration and distribution of IVDs. Additionally, we highlight the key elements pertaining to the requirements for IVDs as delineated in the UK Medical Devices Regulations 2002 (as amended).

Registration of IVDs under MHRA 

Do we need to register our IVD with the UK Medicines and Healthcare products Regulatory Agency (MHRA)?   

Indeed, following the Brexit transition period, it is imperative that all medical devices intended for sale in Great Britain undergo registration with the MHRA before they can be made available in the market.  It is important to clarify that this article is for IVD devices placed on the market in Great Britain (England, Wales, and Scotland).  

Who is eligible to register my IVD with the MHRA? 

The UK Responsible Person serves a role comparable to the European Authorized Representative, assuming key responsibilities such as the registration of your medical device or IVD with the MHRA, among other crucial duties. It is essential that the designated UK Responsible Person is located in the UK. Unlike your importer, your UK Responsible Person’s name will appear on your labeling, specifically if you opt for the UKCA mark instead of relying on the In Vitro Diagnostic Directive (IVDD). 

Which European Union (EU) directive can facilitate the approval process for IVDs under the UK MHRA medical device regulations?  

Fortunately, the existing regulations governing IVDs under the UK MHRA are rooted in the pre-Brexit European Union (EU) directives. Therefore, to obtain UKCA marking for marketing and selling in Great Britain, IVDs must adhere to the stipulations outlined in Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD). 

CE marked IVDs 

Until when is it permissible to export IVDs with a CE marking to the UK? 

You can export CE marked IVDs until 30 June 2030 or up until when your certificate expires as per The Medical Devices (Amendment) (Great Britain) Regulations 2023. It is important to mention that, general IVDs which are self-certified can only be placed on the UK market if the involvement of a notified body is required under the EU IVDR (i.e. if it is an up-classified device or a reusable surgical instrument Class I device).   

Can I continue to sell my IVD in the UK if my CE certificate expires? 

Expired CE certificates do not allow manufacturers to sell in the UK unless such certificates have been approved and validated by the EU.  

Conformity assessment route for different IVD classes 

Which regulation is relevant to understanding the conformity assessment route for various IVD classes? 

Regulation 40 (Part IV of the UK MDR 2002, [as modified by Part III of Schedule 2A to the UK MDR 2002]) helps manufacturers determine which conformity assessment route would best fit their IVD.  A summary is provided in the table below:  

Adhering to the UK MHRA regulations 

What are the responsibilities of an IVD manufacturer according to the MHRA regulations? 

As a manufacturer, you are responsible for following the UK Medical Devices Regulations 2002 (as amended). The device ought to meet the relevant and essential compliance requirements prior to being placed on the UK market, including accurate classification and implementation of an appropriate conformity assessment route. Maintenance of a quality management system (QMS), as well as conducting post-market surveillance activities, is also expected.  

It is crucial to emphasize that the declaration of conformity, technical documentation, decisions, reports, and certificates from UK-approved bodies must be retained and made readily available for future inspections. This obligation persists for a duration of five years from the date of manufacturing the final device.  

UKAB: assessing conformity and quality 

What is the role of the UK-approved body (UKAB)? 

The UKAB gives the manufacturer the type of conformity assessment for their IVD based on the requirements of the UK Medical Devices Regulations 2002 (as amended).This certificate is required for the IVDs to be placed on the market in the UK. 

Typically, the UKAB assesses conformity either through a design examination (review of design documents) or bases the conformity on the type of examination (sample testing). In addition,, UKABs also have a role  in monitoring the quality systems of manufacturers. 

UK IVD evaluations 

Do UK IVD manufacturers need to conduct a clinical evaluation?  

Manufacturers of IVDs are not required to conduct clinical evaluations. However, they are required to perform performance evaluations of their IVDs to ensure compliance with the essential requirements outlined in the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). 

What are some standards and tips for performance evaluation?  

Within the EN 13612 standard, titled “Performance evaluation of in vitro diagnostic medical devices,” published in October 2002, guidance is given on when performance evaluations should be performed.  

Also, with the introduction of ISO 20916 in 2019, definitions of different types of clinical performance studies that include roles, responsibilities, and all parties involved (such as sponsors, study sites, and ethical committees), are now available.   

Do I need to register for a performance evaluation?  

Indeed, there are two ways to register an IVD for a performance evaluation. IVDs are either already in existing and ongoing performance evaluations (started before 31/12/2020) or new studies must be registered with the UK MHRA via a UK Responsible Person (for overseas manufacturers). Also, a Declaration for Performance Evaluation – to UK MDR 2002 Regulation 43 Statement, Annex VIII of Directive 98/79/EC, or Part A of Annex XIII of EU regulation 2017/746 must be provided to register. 

UK IVD post market requirements 

Is it necessary to establish a vigilance system that is specifically designed for the UK MHRA? 

Indeed, as a manufacturer, it is required to establish and maintain a “vigilance system”. This system should be designed to notify the UK MHRA of any incidents that have the potential to cause or have already caused death, serious health consequences, or recalls. While the UK MHRA does not set specific post-market requirements in relation to IVD performance evaluations, changes are expected. Therefore, it is more than likely that manufacturers will have to update their SSCP and PMPF reports throughout the lifetime of the IVD.  

UKCA marking 

What are the steps involved in applying the UKCA marking and language requirements? 

The UKCA marking for an IVD should have the following requirements: 

• • The marking on the device should be visible 
  • The marking on the device should be legible  
  • The marking on the device should be lasting 
  • The marking on the device should have the instructions on how to use the device 

In addition, and if applicable, the corresponding UK-approved body number should be included alongside the UKCA marking, and as per Regulation 35(2), the labels and IFU for a device should be provided in English. 

What changes can we anticipate in the future regarding IVDs in the UK? 

Potential amendments to the UK IVD regulations might involve incorporating more comprehensive requirements regarding the process and documentation of performance evaluations conducted by manufacturers. Further detailing of clinical, scientific, and analytical data requirements and post-market requirements can also be expected.  

Use MedEnvoy as your UK responsible person for your IVDs 

Optimize your compliance requirements with MedEnvoy as your UK Responsible Person for IVD manufacturers. If you have any additional questions regarding UK IVD regulatory compliance, get in touch. 

Learn More about UK regulations regarding medical devices:

• • The Difference Between a UK Importer and Responsible Person 
  • EU Importation and Taxation Considerations: DDP vs DAP  
  • Leveraging Device Clinical Data in Great Britain for IVDR Performance Evaluations