With MDR right around the corner, organizations conducting medical device clinical research are working overtime to prepare for the massive regulatory shifts about to go into effect across the EU. Let’s recap what’s ahead:
• With transparency and safety as key goals, MDR expands the scope of what a medical device is. Devices that previously didn’t need clinical trials now will.
• Organizations will need to present more data than ever and keep stronger ongoing compliance documentation – especially with post-market surveillance.
• Electronic instructions for use (eIFUs): All devices on the market in the EU will need to provide users with mobile phone-accessible product information updated in real time in a user’s preferred language.
And this is just scratching the surface. Other elements of MDR will necessitate more clinical trials, and create greater data management complexities. It’s likely that most device companies will undergo growing pains as they readjust their workflows to meet new standards.
And here’s what’s important to note: it’s not just Europe shaking things up with MDR – device regulations in Asia-Pacific (APAC) are rapidly shifting too. It seems that all researchers, regardless of where they work and do business, will need to reckon with these reforms and respond to global demand for safer, higher-quality devices and a push towards worldwide regulatory harmonization.
For us at Medrio, keeping an eye on these regulatory shifts is crucial to our mission of facilitating clinical trials. Getting bogged down by compliance snags slows researchers’ efforts and keeps their life-enriching work from reaching people in need. A central element of our eClinical solutions is the capacity to easily manage vast quantities of data having peace of mind that information is 100% compliant. During this time of worldwide regulatory flux, we suggest taking the long view and seeing these changes as opportunities to overhaul workflows and innovate. Now is a pivotal moment to set in motion new processes to create higher-value products that enhance people’s lives.
There’s already been a lot of discussion about MDR – let’s dive into some noteworthy regulatory shifts taking place across APAC.
Where are medical device clinical research regulations evolving?
The land down under is dedicated to harmonizing regulations with the EU. In 2016, Australia committed to aligning its medical device rules with Europe “wherever possible and appropriate.” Even with MDR’s stricter regulations, Australia’s Therapeutic Goods Administration (TGA) is still seeking to harmonize. Look at these recent developments:
• In April 2019 the TGA announced plans to improve oversight of new devices entering the market, boost post-market monitoring, and provide more device information to patients.
• The TGA is also looking to upgrade reporting systems by allowing consumers to submit adverse events via smartphone apps. They want to publicize how reporting these events improves safety.
• The country is fast-tracking device reforms to improve transparency and increase public and health professional confidence. Many changes are slated to go into effect starting this year.
China has drastically changed regulations over the past few years. In 2018, China’s National Medical Products Administration (NMPA) published tighter regulations and bigger penalties for noncompliance. But now there’s more:
• In January 2019, the NMPA announced guidelines on inspections of overseas medical device manufacturers. This document clarifies that investigations will target research and development sites as well as manufacturing facilities.
• A fundamental purpose of NMPA’s new regulations is to fulfill a government request to raise the quality of imported products and better serve the public.
In recent years, the government of India has shown a clear inclination to bolster India’s competitiveness in the global medical device market. They’ve also taken steps to ensure higher-quality devices domestically. Take a look:
• In April 2019, the government of India announced mandatory Central Drugs Standard Control Organization (CDSCO) certification for all medical devices sold within the country.
• Just like MDR, these stricter regulations aim to boost safety, performance, and quality standards in medical devices and medical device clinical research.
In the globalized world of clinical trials, huge regulatory shifts like MDR have far-reaching effects. And with stricter regulations emerging in APAC, organizations conducting medical device clinical research, no matter which markets they serve, will need to revamp their processes to stay competitive and easily meet new requirements. For us at Medrio, we’ll keep doing our part to support researchers by making sure our EDC, eSource, ePRO, and eConsent stay on top of the latest regulatory changes. While over the short term stricter regulations may cause some frustration and organizational growing pains, taking this time to ensure you have everything in place to adapt is the best way to keep your path to innovation clear for the long term.