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.
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