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Together with the value chain, Bormedâ„¢ supports implementation of new European regulations, IVDR and MDR

New European legislations, In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR), will come into force sooner rather than later for In Vitro Diagnostic Devices (IVD) and Medical Devices (MD). These new regulations have as an ultimate goal to care for the safety of patients when using medication and when receiving diagnosis.
The IDVR expects an increase from 20% under the current IVD Directive to 80% under the IVD Regulation. This means that devices of many IVD manufacturers, which were not previously certified, will now require certification to keep their products on the market. Hence, time to prepare and get ready for the new European regulations with the right raw materials.

A collaborative approach between IDV/MD manufactures and a reliable raw material supplier becomes important to encounter the changing regulatory market, which may affect your medical and in vitro diagnostics devices. In this changing environment, there will be a need for raw materials that are regulated and documented.
This webinar will bring a compelling case story of a successful collaboration with the IVD value chain, revealing how regulated polyolefin solutions contributed to achieve accurate results in in-vitro diagnostic tests. Accuracy is key in this market as nobody wants to be diagnosed with a false negative/positive result of a contagious disease, because of an unannounced change in the used raw materials.

Furthermore, the webinar will elaborate on the characteristics and properties of a new high flow heterophasic copolymer, recently launched to support developments for medical and in vitro diagnostic devices supporting IVDR and MDR compliance. Being part of the Bormed family of polyolefins, it promises the IVD and MD manufacturers a continuity of supply, change control and a superior product consistency, quality and purity.

With this webinar we will share the learnings from a collaborative approach between the value chain and a reliable raw material supplier supporting applications developments in the wake of the upcoming new European regulations, IVDR and MDR. As well as why the choice of the right partner is as important as the choice of the right material and what the importance of change control is when it comes to the resins you select for your Healthcare applications.