How new regulations are changing the market for medical devices in Europe
For firms engaged in medical technology development that do business in Europe, 2017 brought important changes in the laws governing how they bring products to market. The European Union's new medical device regulation and in vitro diagnostic regulation went into effect in May. To operate in the EU, organizations must be fully in compliance with MDR by 2020 and with IVDR by 2022.
The changes in law require organizations to implement extensive shifts in their processes for medical device design and development. If these companies are to succeed in the years ahead, they must move fast to adapt to stringent laws. By understanding the effects of MDR and IVDR and strategizing accordingly, makers of medical products can position themselves to meet the challenges of competing in the European market.
The new rules for medical devices
"The rules clarify and strengthen clinical reporting requirements."
MDR and IVDR make a number of significant changes to existing laws governing medical products. An introductory guide provided by the UK's Medicines and Healthcare Products Regulatory Agency explained that the rules clarify and strengthen clinical reporting requirements. The laws also change the classifications for certain devices and establish new requirements for the notified bodies that are assigned by EU countries to handle assessment.
The standards for clinical testing and reporting are based on the risks that products present to patients, with four classes laid out for both medical devices and in vitro devices. Low-risk products are categorized as Class I medical devices, like stethoscopes or wheelchairs, or Class A in vitro medical diagnostic devices, which include specimen receptacles and clinical chemistry analyzers. Organizations are permitted to put these items on the market based just on self-assessment, unless a Class I medical device is marketed as sterile, provides measurements or is a reusable surgical instrument.
All other classes must receive approval from a notified body by passing a conformity assessment. Where the notifying bodies once played more of an advisory role, they will now be charged with greater responsibility for enforcing the stringent guidelines.To pass the conformity assessment, devices must be in accordance with an array of general safety and performance requirements, such as:
- Providing clinical evidence that demonstrates the benefits of a product are greater than its risks.
- Meeting various standards for chemical, physical and biological properties in medical device design and manufacturing.
- Including detailed and accurate labeling information.
In addition, manufacturers must also provide appropriate technical documentation. MHRA's director of medical devices, John Wilkinson, explained the motivation behind the changes in a press release.
"Patient safety is our priority," Wilkinson said. "It is expected that the implementation of these new regulations will clarify the role of competent authorities increase post-market surveillance to help protect both patients and industry alike."
How MDR will affect medical product manufacturers
The regulations will alter how medical device makers operate in a variety of ways, as a white paper from the clinical research organization Icon explained. One of the biggest changes is that certification requirements will apply for a far greater segment of IVDs, skyrocketing from around 10 percent of these products to 90 percent. Another is that all devices will be required to carry unique device identification numbers.
Makers of many implantable devices have relied on equivalency statements in the past. They will now either need to conduct studies on their own products, rather than relying on data from competitors, or remove those items from the market. Organizations should also be aware that the classifications for some existing devices may have changed, like in the cases of automated external defibrillators, spinal implants and surgical mesh.
Manufacturers may also face new challenges after their devices go into use. A wide range of products will become subject to post-market surveillance and assessment to monitor their risks. Meanwhile, manufacturers and distributors will face heightened liability in cases where their devices prove defective.
Adapting for the future of medical device innovation
The next few years will be demanding ones for firms creating and selling medical devices in the EU. Corporate leadership must strategize to comply with the regulations while maintaining their competitive footing. The Regulatory Affairs Professional Society offered several pointers on how to shift procedures in anticipation of the new rules coming into full effect:
- Device makers should start by assessing how the regulations will affect all existing products, including any that will be reclassified or require fresh clinical data, technical documentation or labeling.
- Conduct gap analyses to find out what additional resources and personnel will be necessary to bring devices into compliance.
- Every product must pass a thorough review to find out what steps will be necessary to bring it into compliance and assess whether the process is worth the investment.
- Get started early, rather than waiting for late in the transition when the notified bodies could be backed up, and create pilot process to establish clear procedures for moving forward.
- Be prepared to learn further details and make more changes as the regulations roll out.
An agile, forward-looking approach will make the difference in continuing successful medical product development under the latest EU rules. Firms must continue to do exceptional work in areas like human factors engineering and medical user interface design while meeting higher standards for clinically proven effectiveness. For organizations that plan thoughtfully, this transitional period could reveal opportunities for progressing their devices with safety and high performance.