IVDReady webinar series
COMING SOON 26/05/2024 4:07 am
Jun 20, 2023
IVDReady by May 2024 with Platomics

Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.

6. Juli 2023
1. Let’s talk strategy

Das erste, was Ihr Labor braucht, ist eine Strategie für die Dokumentation von Workflows, egal ob Sie 50 oder 250 interne Tests haben. In diesem Webinar werden mehrere mögliche Ansätze vorgestellt.

Jul 25, 2023
2. Give it a purpose

The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.

Aug 29, 2023
3. Perplexity is the beginning of knowledge

This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.

Oct 12, 2023
4. Gate Opening: Introducing the Workflow Studio

Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.

Jan 30, 2024
5. GSPRs are challenging, standards are beautiful

GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done. 

Mar 5, 2024
6. An ounce of validation

We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.

2024
7. The real risk is not managing risk

Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation. 

2024
8. Product excellence: Everything, everywhere, all at once

We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.

2024
9. Vigilance: The shield, sword and light

Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.

2024
10. IVDReady at last

Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.

An annotated
rundown of IVDR
requirements for labs

December 5, 2023
2024 brings a new set of challenges

The IVDR was written primarily with IVD manufacturers in mind, but notably Article 5.5 also makes demands on in-house diagnostic tests developed by labs. And 2024 will bring another round of IVDR rollout for labs.   

Before you fill your lab calendar for the new year, here’s an annotated review of what the IVDR has set out for labs to do—and by when it needs doing. 

As of May 2022:

Labs may not transfer in-house devices to another entity. 

This means you may not for example “borrow” a bioinformatics pipeline created by another lab, nor lend out or sell your homemade analysis software.  

One potentially tricky aspect here is that lab groups need to clarify their legal entities—a concept that differs in each country. Try checking with your national competent authority to see if they have clarified the meaning of “legal entity.”  

Labs may not “manufacture” diagnostic tests on an industrial scale.  

The meaning of this seems obvious for most labs despite the lack of an IVDR definition for “industrial scale.” The purpose here is to hinder loopholes around the obligation to CE-mark devices produced at scale. 

The MDCG has issued the following guidance: Industrial scale is not synonymous with “mass-produced” and does not rule out a high number of a given diagnostic test within one lab. The general rule: your lab should not produce more than you would use to fulfil the projected needs of the patients at your health institution. 

Labs must ensure that each in-house test fulfills Annex I of the IVDR, which entails the General Safety and Performance Requirements (GSPRs). 

The GSPRs represent the meat of the IVDR and this requirement has been in full force since May 2022. All IVDs—whether industrially manufactured or lab-developed—must meet the nearly 200 requirements and sub-requirements. Responsibility for the implementation and documentation of in-house devices lies with the laboratory.  

This applies also to CE-marked products used in your lab if you modify their use from that intended by the manufacturer, as well as to your in-house developed workflows with multiple components and steps.  

GSPRs are typically documented with a GSPR checklist for each in-house device, whereby there are different strategies available to labs regarding how to group in-house devices.

Starting May 2024 labs must also:

Implement a quality management system “appropriate” for the manufacture and use of in-house devices, and additionally fulfill ISO 15189 or a similar standard accepted by their national competent authority.

The IVDR requires labs to implement a quality management system that can jump through two hoops at once.  

On the one hand, this system must fulfill the lab quality requirements of ISO 15189 or a similar nationally accepted framework. ISO 15189 accreditation is a reliable way to demonstrate conformity and therefore expected in many EU countries.

On the other hand, processes specific to in-house manufacturing must also be considered—an aspect not necessarily covered by ISO 15189. This manufacturing aspect must therefore be supplemented on top of the standard lab quality requirements. Perhaps the easiest route is to create procedures based on development processes from ISO 13485, which specifies QMS requirements for medical device manufacturers.

The take-home message here is that ISO 15189 is not enough now that labs are considered the quasi-manufacturer of their in-house devices.  

Provide authorities with information and a rationale on the manufacture, modification and use of in-house devices.  

In other words: You need to justify why you have developed and use a given in-house test. 

File extensive technical documentation on the design, manufacture and performance of high-risk class D devices. 

National competent authorities may extend this to other risk classes as well. Switzerland has already enshrined this in national law for all risk classes, and Germany is on track to require it for class B and higher. Other countries are expected to follow suit.  

Collect and review experiences from clinical use and undertake corrective action as necessary.  

Labs are newly required to monitor clinical use of their lab-developed tests and apply corrective action when necessary.  

This is the lab corollary of manufacturers’ obligation under IVDR to perform post-market surveillance. Note that this new IVDR demand on manufacturers means that they will likely expect labs to set up procedures for reporting back to them regarding clinical use of their products.  

The final hurdle starting in 2028

Labs must justify how patients’ needs are better met with an in-house test over a comparable CE-IVD-marked device on the market.  

This is perhaps the most contentious single aspect of the entire regulation. The idea boils down to this: In the future labs may only use in-house tests if they monitor the market and do not find an “equivalent” CE-marked assay to fulfil target patient needs.  

But the idea of “equivalence” is not easy to interpret. According to the MDCG, “non-equivalence” can be based on technical, biological or clinical aspects, including for example differences in intended purpose, clinical conditions, patient groups, critical technical specifications or performance characteristics. 

For more information regarding the points raised here, see MDCG 2023-1 

Now take a few deep breaths before it’s time to ring in the New Year!

 

* Disclaimer: We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.