The Regulation, which is replacing the Directive, will have significant impact on the use of research-use only (RUO) and In-House In Vitro Diagnostic (IH-IVD) products in clinical laboratories.
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OVERVIEW When will the IVDR be implemented?
When the IVDR document was published in 2017 full application of the IVDR was scheduled for 26 May 2022. However, enforcement of the IVDR is the responsibility of individual countries national competent authorities, in the UK this is MHRA. In the UK, as in the EU, guidance documents are still pending. It has to be noted that in 2017 the UK was still a member of the EU. Under the IVDR, use of CE-IVDs is the default option, The continued use of IH-IVDs will only be acceptable when a number of specific conditions are met. This entails that from the date of application of the IVDR onward, all diagnostic laboratories in the EU that implement IH-IVDs for diagnostic patient care are obliged to be in compliance What impact will the switch from In Vitro Diagnostics Directive (IVDD) to In Vitro Diagnostics Regulation (IVDR) have on the use of RUO controls? • RUO controls will not be acceptable for use in an IVD process. • Dilution of CE-IVD products turns them into RUO products, this is not acceptable
When it comes to Quality Controls – what is the difference between CE-IVD and RUO?
The simple answer of course is RUO products are developed for research use only and IVD products are developed for use with in-vitro diagnostics. |
LIBRARY There are many documents and webinars on-line. Some are authoritative some educational. These are just a few
click for links 
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What gives IVD products the edge over RUO products when it comes to choosing quality controls for use in the clinical laboratory?
CE-IVD products require regulation to ISO 13485 - RUO products do not.
• CE-IVD products require extensive validations including scientific validity, analytical performance, and clinical performance.
• RUO products are not regulated and do not require validation
• CE-IVD products require a Notified Body to grant conformity certificates. RUO products are not regulated.
• CE-IVD products are developed for IVD use - RUO products are designed for research and development
CE-IVD products require regulation to ISO 13485 - RUO products do not.
• CE-IVD products require extensive validations including scientific validity, analytical performance, and clinical performance.
• RUO products are not regulated and do not require validation
• CE-IVD products require a Notified Body to grant conformity certificates. RUO products are not regulated.
• CE-IVD products are developed for IVD use - RUO products are designed for research and development
When are RUO products acceptable for controlling IVD tests?
• The only time a case for using a RUO control with an IVD test can be made is when no CE-IVD alternative is available.
• When a new diagnostic test is introduced to the market it is likely there is not yet a third-party CE-IVD product available. RUO controls can be brought to market much faster than CE-IVD controls because their validation requirements are lower.
• When a CE-IVD control becomes available this should replace the ‘stop-gap’ RUO.
• The only time a case for using a RUO control with an IVD test can be made is when no CE-IVD alternative is available.
• When a new diagnostic test is introduced to the market it is likely there is not yet a third-party CE-IVD product available. RUO controls can be brought to market much faster than CE-IVD controls because their validation requirements are lower.
• When a CE-IVD control becomes available this should replace the ‘stop-gap’ RUO.
What impact will the switch from In Vitro Diagnostics Directive (IVDD) to In Vitro Diagnostics Regulation (IVDR) have on the use of IH-IVD controls?
Only when no equivalent CE-IVD is available, or a target patient group’s specific needs cannot be met at the appropriate level of performance by an equivalent CE-IVD, is use of an IH-IVDs allowed.
The continued use of IH-IVDs will only be acceptable when a number of specific conditions are met. This entails that from the date of application of the IVDR onward, all diagnostic laboratories in the EU that implement IH-IVDs for diagnostic patient care are obliged to be in compliance
Under the IVDR, use of CE-IVDs is the default option.
- - The IVDR dictates requirements for use of IH-IVDs.
- - Only when no equivalent CE-IVD is available can an IH-IVD be used.
- - Exemptions only apply in specific cases and specific conditions must be met .
Only when no equivalent CE-IVD is available, or a target patient group’s specific needs cannot be met at the appropriate level of performance by an equivalent CE-IVD, is use of an IH-IVDs allowed.
The continued use of IH-IVDs will only be acceptable when a number of specific conditions are met. This entails that from the date of application of the IVDR onward, all diagnostic laboratories in the EU that implement IH-IVDs for diagnostic patient care are obliged to be in compliance
Under the IVDR, use of CE-IVDs is the default option.
References, Regulatory Agencies, Governing Bodies
In Vitro Diagnostic Regulation (IVDR) 2017/746 will fully replace Directive (IVDD) 98/79/EC on on May 26, 2022, in vitro diagnostic medical devices* after a transitional period of 5 years.
CE – under IVDR the conformity certificate will be issued by a registered Notified Body (eg BSI)
ISO 13485:2016 Medical Devices Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority in the UK.
(EU) MDR – Medical Devices Regulation
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/ EU. 2017. Available at: https://eur-lex.europa.eu/eli/ reg/2017/746
In Vitro Diagnostic Regulation (IVDR) 2017/746 will fully replace Directive (IVDD) 98/79/EC on on May 26, 2022, in vitro diagnostic medical devices* after a transitional period of 5 years.
CE – under IVDR the conformity certificate will be issued by a registered Notified Body (eg BSI)
ISO 13485:2016 Medical Devices Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority in the UK.
(EU) MDR – Medical Devices Regulation
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/ EU. 2017. Available at: https://eur-lex.europa.eu/eli/ reg/2017/746
