Looking to understand the new EU rules for medical devices (“EU MDR”)? Check out the European Commission’s “Fact Sheet for Healthcare Professionals and Health Institutions.” The new regulation was adopted in May 2017. A three-year transition period ends in May 2020, meaning device companies and authorities need to be compliant by then.
The EU MDR allows for the reprocessing of SUDs if it’s also permitted under national law and in compliance with Article 17 of the EU MDR. That means, in addition to meeting medical device manufacturer requirements as outlined in the MDR, each EU member must permit such products under national law. AMDR is urging members to “opt in,” meaning, to elect to allow remanufactured SUDs that are CE marked – meaning they conform to the EU MDR’s requirements. Belgium and the Netherlands have already taken steps to do so and have reported such to the Commission. AMDR is in touch with numerous other Member States taking action, including Germany, Ireland, Portugal, Slovenia and the UK.
Opting into Article 17 of the EU MDR promotes safety. Article 17 gives Ministries of Health authority to stop any inappropriate SUD reuse of single use devices that may be happening in hospitals and promote only safe, regulated SUD reprocessing and remanufacturing. Patients deserve to know that all devices used on them meet the same standards.
Countries that opt in will promote competition and drive down costs. Allowing CE marked remanufacturing of SUDs provides governments a useful tool to combat growing medical device costs as remanufactured devices can be, on average, 30 percent less expensive than buying new. In 2018, hospitals that used safe, regulated reprocessed devices saved over US$470 million. These savings will only grow annually in the EU thanks to the MDR.
Medical device manufacturers have also been known to lower their prices for new equipment when faced with economic competition from reprocessors.
Countries that opt in will also reduce medical waste. Article 17 addresses the environmental consequences of our “disposable” healthcare culture. Incineration of healthcare waste leads to pollutants in the air that can make people sick. Healthcare should not be making our patient populations sicker. Further, healthcare waste is expensive to dispose of, and by reprocessing and remanufacturing, hospitals save additional money in waste hauling fees.
AMDR member reprocessors meet medical device manufacturer standards, as required by law. As with any novel technology, there is sometimes resistance by the established industry. Reprocessors are not asking they be cut any corners – they will demonstrate their products meet the EU MDR’s requirements and include voluminous data supporting their cleaning, design/functional performance and disinfection and sterilization validations in their required submissions to regulators.
The EU MDR’s placing of SUD reprocessing as a manufacturing activity solves legal, regulatory, safety and fairness issues. If all would-be SUD reprocessors are placed on a level playing field, we know that all devices, new, reprocessed or remanufactured, are safe and effective for patients. We ensure that SUD reuse in hospitals, or another non-confirming reuse, is stopped. OEMs are not held responsible for commercially reprocessed devices, and know their competitors are being held to the same standards. With these principals in place, reprocessors are eager to enter the various Member State markets, lowering medical device costs and reducing medical device waste.