IVDR

Beginning on May 26, 2022, in vitro diagnostic medical devices to be sold in the European Union must comply with the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Following the implementation of MDR, HARTMANN now shifts focus to handling this next regulation phase.

IVDR represents several changes, the biggest one is the assignment of products to one of four risk categories ranging from class A (lowest risk) to class D (highest risk). This means that around 85% of all IVDs will need Notified Body oversight under the new IVDR, compared to 20% under the previous IVDD. Additionally, an effective quality management system must be established and certified that documents, maintains, and updates regulatory compliance for applicable products.

Similar to new standards such as MDR, the IVDR will usher in increased transparency, with information on IVD devices and ‘higher risk’ performance studies being made public. Once IVDR is in place, a unique device identifier (UDI) for every IVD device will then significantly enhance traceability and support post-market safety activities.

As with any new regulation, gaining compliance presents a challenge to the health sector – primarily because so much documentation needs to be provided through several rounds of approval. These changes could adversely affect the availability of medical devices for health institutions. Manufacturers may even choose to stop the production of certain medical devices. Additionally, the insufficient number of Notified Bodies means there are often long waiting times, which may ultimately disrupt supply chain lines.

Happily, HARTMANN has a strong and longstanding partner with Notified Body TÜV SÜD who is already accredited not only against the MDR but also against the IVDR. Unlike with MDR, when it comes to IVD products, HARTMANN is a distributor only, for example of self-tests, and not a manufacturer. As distributor, HARTMANN needs to make sure by representative sampling that the devices they distribute are compliant with the obligations described in IVDR. This means our work lies less in development and research and more with procurement.

Rather than wait for our partners for IVD products to come forth, HARTMANN’s Procurement team has already begun to proactively communicate with its contacts. We plan to identify trouble spots well in advance. If we can no longer guarantee that certain IVD products are regulatory compliant, we will offer customers suggestions for replacements or similar products. HARTMANN will help ensure that customers do not experience any supply shortages in the IVD products we distribute.

While our portfolio is broad, we stay on top of developments. The company actively cooperates with regulatory bodies in Germany, the European Union, and even abroad, so we know early on what to expect. With IVDR and other upcoming regulations like BPR, we are not caught by surprise by changes and instead are prepared early on to react and share that knowledge with partners and suppliers. Whether MDR, IVDR or BPR and beyond, HARTMANN has got this!