IVDR - A WORK IN PROGRESS
This Library is a collection of documents, news items and useful links. We will try to keep it updated, like IVDR is is a work in progress!
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.
Here are three blog posts from Microbiologics' Optimal QC in the Clinal Laboratory series.
click on the graphic to access the documents.
click on the graphic to access the documents.
THE NECESSITY OF EXTERNAL CONTROLS
by Lindsey Drake PUBLISH DATE: MARCH 30, 2023
by Lindsey Drake PUBLISH DATE: MARCH 30, 2023
WHY THIRD-PARTY CLINICAL QC IS CRITICAL
by Lindsey Drake PUBLISH DATE: MAY 10, 2023
This blog post is the second in our Optimal QC in the Clinical Laboratory series.
by Lindsey Drake PUBLISH DATE: MAY 10, 2023
This blog post is the second in our Optimal QC in the Clinical Laboratory series.
IN VITRO DIAGNOSTIC USE (IVD) VERSUS RESEARCH USE ONLY (RUO) IN THE CLINICAL LABORATORY
by Lindsey Drake PUBLISH DATE: APRIL 3, 2023
This blog post is the third in our Optimal QC in the Clinical Laboratory series.
by Lindsey Drake PUBLISH DATE: APRIL 3, 2023
This blog post is the third in our Optimal QC in the Clinical Laboratory series.
Other items of interest
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IVDR NEWS ISO 15189:2022Medical laboratories —requirements for quality and competence
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). Publication date : 2022-12 Link https://www.iso.org/standard/76677.html Link IBMS http://bit.ly/3HhPsbW The UK Conformity Assessed (UKCA) mark is due to replace the European Union’s CE markings on products sold in England, Wales and Scotland.
The UKCA mark will come into force on 1 Jan 2021, although CE marking will continue to be recognized in the UK until the end of 2024. However, from the beginning of 2025 only products with UKCA marking will be accepted in Great Britain. On the 25th of October 2022 the MHRA (Medicines and Healthcare products Regulatory Agency) announced that the mandatory deadline to achieve UKCA marking is extended by 12 months to July 2024.
October 2022 -MedTech are now analysing a 2022 survey repeating the 2021 survey.
During the month of July 2021, MedTech Europe members participated in a survey assessing the availability of IVDs after the entry into full application of the In vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. This is the headline result of the 2021 survey: 'At least 22% of IVD tests on the market today will be discontinued for the IVD Regulation. In addition to this, many more IVDs will be lost if no urgent solutions are found to address the existing transition issues to the IVD Regulation. http://bit.ly/3Vpfu0F In July, certificates had not yet been issued for 88% of devices.' 5 August 2022
Directorate-General for Health and Food Safety - Call for EU reference laboratories sent to Member States. In July 2022, the European Commission sent a call for EU reference laboratories under Regulation (EU) 2017/746 to the EU Member States, as well as Iceland, Norway, Liechtenstein and Turkey. The deadline for Member States to submit nominations to the Commission is 31 March 2023. Interested candidate laboratories should contact their Member State for further information and instructions. Currently no EURLs are designated under Regulation (EU) 2017/746. In July 2022, the European Commission sent a call for applications to Member States for EURLs in 8 categories of class D devices:
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 current guidance is as follows: May 26, 2025 for Class D devices May 26, 2026 for Class C devices May 26, 2027 for Class B devices May 26, 2027 for Class A sterile devices May 26, 2022 for non-sterile self-declared devices May 26, 2022 for all new devices Guidance for Classifications relating to diagnostic devices: Class d is high risk eg. blood grouping and life threatening infections Class c covers sexually transmitted diseases amongst other Class b is where the majority of diagnostic tests fall Class a non-sterile - culture media 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 |
IVDR SOURCES There are many documents and webinars on-line. Some are authoritative some educational. Those below are just a few
click for links 
Future regulatory changes for medical devices and IVDs: the pathology edit
February 2023 A new series of articles on the changing state of regulation for medical devices and in vitro diagnostic equipment, Ashleigh Batchen, Head of Regulatory Affairs at BIVDA (the British In Vitro Diagnostics Association) writes for Pathology in Practice looking at the current situation and forthcoming changes as a result of Brexit. Are you up to speed on how these changes might impact you as a user? 
CE marking deadline
From the 1st January 2025, CE Marking will no longer be accepted on most new products placed on the market in Great Britain and UKCA will be required. The UKCA (UK Conformity Assessment) mark is the new UK product marking that will be required for certain products being placed on the market in Great Britain (England, Wales and Scotland). It covers most products that previously required the CE mark 
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IVDR Questions
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.
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.
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?
- - 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 .
- Under the IVDR, use of CE-IVDs is the default option.
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- 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.
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
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, 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.
