Leveraging Device Clinical Data in Great Britain for IVDR Performance Evaluations

One of the challenges being experienced by IVD manufacturers, in meeting the requirements of the IVDR, is ensuring (and justifying) that an appropriate level of clinical evidence has generated enough data for their devices for a performance evaluation. For example:

• • The defined clinical benefit is achieved; 
  • If the IVD is safe; 
  • The IVD is in conformity with the applicable GSPRs; 
  • The intended purpose and performance of the IVD, as stated by the manufacturer, is supported while addressing the residual risks to patients, users, or other persons associated with device use. 

Utilizing clinical experience for IVDR performance evaluation in Great Britian

With the extension of the UK MHRA’s transition timeframe for CE-marked devices under The Medical Devices (Amendment) (Great Britain) Regulations 2023 and the UK Medical Device Regulations 2002 (UK MDR 2002) maintaining alignment with the IVDD (while the MHRA works on finalizing its new regulatory framework), there is a window of opportunity for manufacturers of IVDs self-certified under the UK MDR 2002 which require Notified Body involvement under the IVDR to utilize clinical experience in Great Britain in their IVDR performance evaluations. 

Forms of IVD clinical evidence under the IVDR 

Under the IVDR, IVD clinical evidence is established, assessed, and analyzed through the collection of data in the process of performance evaluation. When determining and justifying the level of clinical evidence, the amount and quality of supporting data should be evaluated following the principles of evidence-based medicine, including an assessment that considers data strength, robustness, and quality. [1] 

As we’ve covered previously, data on IVD scientific validity, analytical performance, and clinical performance are the foundation of IVDR performance evaluation. However, it’s important for manufacturers to also remember that under Section 1.2, Part A, Annex XIII of the IVDR, to demonstrate the scientific validity, the analytical and clinical performance of an IVD: 

“As a general methodological principle the manufacturer shall: 

–         Appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device; 

–         Generate any new or additional data necessary to address outstanding issues.” 

While there is no definition for “clinical data” established in the IVDR, under Article 2(48) of the MDR such data includes “information concerning safety or performance that is generated from the user of a device and is sourced from…clinically relevant information coming from post-market surveillance…”, so it is reasonable for such data on IVDs to be considered clinical data for such devices. Furthermore, MDCG 2020-6 includes complaints and vigilance data (curated data) and proactive PMS data, and while there is no equivalent guidance for legacy IVD devices, it is also reasonable to assume that such data would also be considered similar to the hierarchy of clinical evidence provided as an example of Annex III of this guidance. 

  [1] For example, through the utilization of critical appraisal tools established by the University of Oxford Centre for Evidence-Based Medicine. 

Using notified bodies within an IVDR performance evaluation

We also know from experience with Notified Bodies that data on vigilance reporting are viewed as “other clinical evidence” under the IVDR, and that manufacturers are encouraged to use data such as PMS data to support the argument that the device is safe and effective, as well as demonstrating that the device is state-of-the-art in medicine.   

Therefore, vigilance reporting and PMS data for a CE-marked device placed on the Great Britain market could be used when compiling an IVDR performance evaluation report (as justified by the manufacturer). 

Valid CE marking for IVDs marketed in Great Britain

The MHRA, after industry consultation, is still in the process of preparing its new device regulatory framework – another impact of Brexit and the EU’s transition to the IVDR. While the MHRA had previously announced its transition timeframe extension for CE-marked devices to July 2024, it has only just in June 2023 established a longer timeframe during which CE-marked IVDs can be placed on the Great Britain market. 

The Medical Devices (Amendment) (Great Britain) Regulations 2023 provide that CE-marked IVDs compliant with the IVDD which require Notified Body involvement under the IVDR can be placed on the UK market up until the sooner of expiry of the certificate or 30 June 2030. [2] As approximately 90% of IVDs are self-certified under the IVDD and approximately the same percentage of IVDs require Notified Body involvement under the IVDR, these measures recently established by the MHRA for self-certified IVDD devices requiring Notified Body involvement under the IVDR, may be placed on the Great Britain market before the manufacturers can achieve CE certification under the IVDR. As indicated above, such data can be used within the IVDR performance evaluation process. However, this potential will only be able to be properly assessed once the proposed measures have been approved by the British parliament. 

[2] https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

Learn more about Great Britian IVDR performance evaluation requirements with MedEnvoy

If you have any questions regarding transitioning your devices to the IVDR within Great Britian or for further understanding of the IVDR performance evaluation requirements, get in touch. 

Related articles

• • Linking IVDR Performance Evaluations and Risk Management
  • PMPF Under the IVDR: Methods, Justifications, and Triggers
  • What is the Difference Between PMS and PMPF Under the IVDR?