The biggest myths about IVDR

As of 27 May 2022, the new Regulation (EU) 2017/746 (IVDR) is in full force. Due to the last-minute amendment of the Regulation, there are a lot of myths associated with the current IVDR status. What are the most widespread?

Myth #4: IVDR requirements do not apply to deliveries under former contracted tenders

Laboratories often believe that if a contract for the supply of IVD products was entered into prior to 27 May 2022, they do not need to check the product documentation for the entire duration of the contract. However, if Class A IVDR products are also supplied as part of the tender, then those manufactured after 26 May 2022 are subject to the new IVDR. The laboratory must therefore ensure that it has valid EU Declarations of Conformity for these products so that it can demonstrate compliance of its quality management system with the applicable legislation when audited by an accreditation or certification body. Failure to do so could put your lab at risk of potential NON-CONFORMITY (as we explained in Myth #2).

We can assure our customers that whether we supply our products under tenders or not, new EU declarations of conformity for all our instruments and extraction kits have been available since May 2022!

Myth #3: IVDR does not affect labs running  

Despite the extension of the deadlines for the use of in-house manufactured products (IVDR amendment No (EU) 2022/112), the new IVDR is very strict on this issue. Currently, IVDR applies to devices that are manufactured and used within a single legal entity. This means that laboratories may not share their internally manufactured devices, even between entities that are related in some way.

In addition, beginning in 2024, laboratories using in-house methods must ensure:

• appropriate quality management system covering production of this device
• the laboratory of the healthcare facility must comply with EN ISO 15189, including national provisions on accreditation
• a publicly available statement that IVD device meets the General Safety and Performance Requirements (GSPR) set out in Annex I
• reviewing the experience gained from the clinical use of devices and taking any necessary corrective action (Post-Market Surveillance - PMS)
• Class D products - documentation of manufacturing equipment, manufacturing processes, design data and functional capability of the device, including the intended purpose.

At GeneProof, we know that the role of laboratories is to perform tests and that time is valuable. Leave all IVDR duties to us by choosing from our  wide range of compliant products and save your lab’s time for the tasks that matter most. 

Myth #2: IVDR does not currently apply to laboratories

False. It is a common misconception among laboratories that they are not affected by the new IVDR and that the responsibility for any mistakes in compliance lies solely with the IVD product manufacturer.

However, each laboratory must be accredited (e.g. according to EN ISO 15189:2012) and, where applicable, have a certified quality management system. If the accreditation or certification body finds during a periodic audit that the laboratory does not have valid documentation for the products used, the laboratory may be found to be in NON-CONFORMITY. In this case, the lab is fully accountable and risks all the consequences that this implies.

If a laboratory is currently using, for example, nucleic acid extraction kits manufactured after 26^th May 2022, and does not have a valid EU Declaration of Conformity according to the IVDR for these products, it runs the risk that examinations performed during the reporting period will not follow their quality management system. According to it, these examinations may have been carried out in breach of the applicable legislation by using a non-certified product.

At GeneProof, we value our customer partnership and would never compromise the operation of their laboratories. You can download the valid EU Declarations of Conformity for “A” Class products on the respective product pages.

Myth #1: Required adherence to the new IVDR has been postponed.

False. As of 27 May 2022, the new Regulation (EU) 2017/746 (IVDR) is fully applicable. Even though transitional provisions have been adopted for some IVDs, Class “A” IVD devices (non-sterile) are fully subject to Regulation 2017/746 (IVDR) - there is no deferral or transition period.

This means that all nucleic acid extraction kits and IVD instruments must be CE IVD certified according to the IVDR from May 2022. The new EU Declaration of Conformity must be issued and all General Safety and Performance Requirements must be met.

You can rely on GeneProof! All our extraction kits and instruments are of course IVDR certified! See a full listing here.

Follow us – to be continued soon!