The European Parliament recently raised the blood pressure of numerous manufacturers by voting to approve two new sets of specifications for entities selling medical devices in Europe. The Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) will be implemented gradually over the next few years, but affected manufacturers will need to get started on compliance as soon as possible due to the significantly expanded requirements. For one thing, MDR and IVDR are bringing into their domain several classes of devices that previously went unregulated. They are also boosting the amount of clinical evaluation and quality management necessary for products to be acceptable. Given the scope of these regulations, it’s important for manufacturers to avoid underestimating the work that needs to be done.
No matter how challenging it may be to comply with these regulations, they are being implemented for a very good reason. Patients’ safety depends heavily on the accuracy of diagnostic testing equipment and the reliability of other complex medical devices. In some cases, like kidney dialysis, patients’ blood is run through a machine and then returned to them in a series of cycles lasting several hours. If this machine fails, or its self-cleaning mechanism turns out to be faulty, patients could die. That’s why MDR and IVDR are steadfast in the pursuit of exceptional quality and proven reliability.
Although it might not be immediately apparent, these new developments on the European market have a lot to do with Omron Microscan’s world of barcode scanning and imaging devices. One of the key aspects of medical device manufacturing that the new regulations seek to improve is traceability, and the main ingredient in a system that promotes traceability is the multitude of machine-readable codes adorning products and the individual parts that make them. MDR and IVDR decree that devices must comply with an upgraded traceability system based on Unique Device Identification (UDI) codes that will be recorded in a comprehensive EU database. This is very important for medical device safety because it ensures that devices will be tracked throughout the supply chain, allowing any defective ones to be quickly and easily recalled.
In addition to raising the bar on traceability, MDR and IVDR will require medical device manufacturers to establish systems (or upgrade existing ones) for quality and risk management. Devices will be subject to more rigorous clinical evaluation before they are considered market-ready, and more types of medical products will now be coming under the scope of the regulations. Newly regulated medical devices will include cosmetic implant devices and even colored contact lenses that are used for decorative purposes rather than for improving vision. After all, colored contact lenses do get placed upon the eyes just like prescription contact lenses, so safety is still important even if they don’t serve a medical purpose. All companies that make medical devices will need to designate at least one “qualified person” who will be responsible for directing compliance with the new MDR requirements, and organizations that are authorized to evaluate products to confirm compliance (known as EU Notified Bodies) will significantly ramp up their post-market oversight.
The new regulations were published earlier this year and a timeline has gone into effect to help manufacturers transition to their full implementation in 2022. Although this seems like a long way off, the demands on companies planning to continue selling medical devices in Europe are significant and it’s important to start working on compliance as soon as possible. A surge of work for the Notified Bodies is expected to occur, so any delay in submitting products for compliance evaluation increases the risk of not meeting the deadline.
Watch our on-demand webinar to learn more about European MDR and label compliance here.
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