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Boulder iQ Details 4 Key Regulations Medical Devices Manufacturers Must Act On Now
Date:11/3/2018

As 2018 comes to a close, significant changes to medical device regulations in the European Union (EU) continue to alter the landscape of quality systems for manufacturers worldwide. To mark World Quality Day this month, Boulder iQ outlines four key changes medical device makers must act on now.

“While 2020 may sound far off, the May 26 deadline transition deadline that year for the new Medical Device Regulation in the EU requires medical device manufacturers to take specific actions immediately,” says Carrie Hetrick, vice president of regulatory and clinical affairs at Boulder iQ, an expert consulting firm specializing in regulatory, quality and clinical compliance services for medical device and in-vitro diagnostic companies.

Among the many changes manufacturers will face, following are some of those requiring immediate attention, says Hetrick.

1.    Increased scrutiny on clinical evaluation reports (CERs) – Devices equivalence arguments may be more difficult to make, and may be more frequently challenged by notified bodies. Companies must show that their device has the same technical, biological and clinical characteristics, and demonstrate sufficient access to the data on the equivalent device. Then, says Hetrick, updates to CERs may also trigger updates to use instructions.

2.    New requirements for clinical investigations – Manufacturers will need to conduct these investigations according to the new legislation and recognized ethical principles, as well as be in sync with the clinical evaluation plan.

3.    Stepped-up activity for post-market clinical follow-up (PMCF) – Notified Bodies will look for current, active PMCF reports and plans.

4.    Increased frequency of safety and clinical performance summaries – The new regulations stipulate these must be updated yearly, at a minimum.

Because all companies that sell their devices in the EU must meet the MDR – as well as other requirements affecting quality systems, classification rules and technical documentation – the demand for expertise and help navigating the maze is significant, and growing, says Hetrick. “We are already seeing the bottleneck the new regulations are creating. Many medical device manufacturers are not equipped to handle all of the changes internally, and will need to look for additional implementation expertise, or risk orphaned devices.” Some requirements will extend beyond 2020, she adds, making it even more necessary for medical device manufacturers to find a quality systems expert with whom to partner.

About Boulder iQ (http://www.boulderiq.com)
Boulder iQ is an expert contract consulting firm for medical device and industrial product design and development. Formed as a merger between Boulder BioMed and Samson Design Associates Inc., Boulder iQ offers regulatory, quality and clinical compliance services for medical device and in-vitro diagnostic companies, and design, development and manufacturing for medical device, consumer and industrial products.

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