It’s been an extremely challenging process, but ECM Europe has now succeeded in submitting two MDR dossiers. This is a significant step towards full certification. Maarten Kanters, our Quality Assurance & Regulatory Affairs manager, explains what was necessary to accomplish this, and the consequences it will have.

The Medical Device Regulation (MDR) is the European legislation governing medical devices. It has been in place since 2021, but is unlikely to take full effect until after 2028. Maarten: “The MDR exceeds the old MDD regulations, which were far less stringent. By comparison, the MDR requires much more testing, substantiation and a greater burden of proof. While collecting all that data is an intensive process, it is a good development as far as patient safety is concerned.”

“In February, we submitted the technical dossier for Medical Tubing Sets (MTS) for review by SGS. A couple of months later, we also submitted our technical dossier for Extracorporeal Circuit System Packs (ECC SP). We’re very proud of this.”

Flexible MDR system

The first dossier was for a tubing set that we certify ourselves. This is used to connect the patient with a machine. The other was for the tubing set we manufacture in combination with other medical products that are certified by suppliers, such as a hemofilter, oxygenator or blood pump. “The first dossier was not easy, but the second one really took an enormous amount of work,” says Maarten. “It concerns a flexible MDR system for product families, which is set up to allow us to add new products and variants easily. This means we don't have to go through entire pathways each time, but can provide customization for almost any set, with certified components.”

Extensive testing, bulky reports

“In order to future-proof this system, we really pushed the absolute limits of the product families,” continues Maarten. “For this purpose, ECM carried out numerous tests and had them performed by others. Not only on the packaging, but also on the sets themselves, ranging from pressure and leakage tests to aging and biocompatibility tests. These investigations are costly, take a lot of time and produce bulky reports. We incorporated all of the results into our risk files and verification and validation documentation. That was quite a challenge.”

Freedom for clients

The intensive preparations are expected to pay off in the future, particularly for clients. Maarten: “Our MDR system gives clients and users a lot of freedom because we can add new variants quickly. This means clients can respond faster to changing wishes or requirements, and they retain their freedom of choice, speed and the certainty that everything is demonstrably compliant with the MDR. In other words, we continue to deliver safe, customized products quickly and flexibly, despite the stricter regulations. And we do so despite the fact that we are seeing increasing standardization in the field of medical devices.”

Certification in early 2026

The dossiers are now with the notified body, which may require a couple more rounds of questions before final approval. “We expect to receive our MDR certification early in 2026, which will position us well ahead of the market,” concludes Maarten. “Much more importantly, however, we are progressing in terms of reliability and future-proofing. For our customers, this is extra confirmation that they can continue to count on ECM in the future.”